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Monday, October 10, 2016

Guaifenex PPA 75

Generic Name: guaifenesin and phenylpropanolamine (gwye FEN e sin/fen ill proe pa NOLE a meen)

Brand Names: Ami-Tex LA, Banex-LA, Coldloc-LA, Dayquil Sinus Pressure and Congestion, Despec, Entex LA, Exgest LA, G-Vent, Guaifenex PPA 75, Guaivent, Guiatex LA, Naldecon-EX Pediatric, Nasahist LA, Phentex-LA, Phenylfenesin LA, Poly-Vent, Profen LA, Stamoist LA, Triaminic Expectorant, Vanex-LA

What is Guaifenex PPA 75 (guaifenesin and phenylpropanolamine)?

Guaifenesin is an expectorant. It is used to break up congestion and mucous to make breathing easier. Guaifenesin thins mucous, increases lubrication of the respiratory tract (lungs, nose and throat), and increases the removal of mucous.

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries), which reduces swelling of mucous membranes in areas such as the nose and sinuses.

Guaifenesin and phenylpropanolamine is used to treat the symptoms of the common cold and of infections of the sinuses, lungs, and throat.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Guaifenesin and phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Guaifenex PPA 75 (guaifenesin and phenylpropanolamine)?

Drink plenty of extra fluids while taking this medication. Do not crush or chew the tablets. Swallow them whole or break them in half where they are scored to make them easier to swallow if needed.

Who should not take Guaifenex PPA 75 (guaifenesin and phenylpropanolamine)?

Do not take guaifenesin and phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

high blood pressure or any other type of heart disease,

diabetes,

a peripheral vascular disorder (poor circulation),

glaucoma or increased pressure in the eyes,

an overactive thyroid, or

difficulty urinating or an enlarged prostate.

You may not be able to take guaifenesin and phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Guaifenesin and phenylpropanolamine is in the FDA pregnancy category C. This means that it is not known whether guaifenesin and phenylpropanolamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication passes into breast milk and may harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from guaifenesin and phenylpropanolamine. You may require a lower dose of this medication. Guaifenesin and phenylpropanolamine has not been approved for use by children younger than 6 years of age.

How should I take Guaifenex PPA 75 (guaifenesin and phenylpropanolamine)?

Take guaifenesin and phenylpropanolamine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Increasing fluid intake during the day may help relieve congestion. Take guaifenesin and phenylpropanolamine with food if it causes stomach upset. Do not crush or chew the tablets. Swallow them whole or break them in half where they are scored to make them easier to swallow if needed. Store guaifenesin and phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a guaifenesin and phenylpropanolamine overdose include vomiting, high blood pressure (headache, redness of face, blurred vision), an irregular heartbeat, and numbness of the fingers or toes.

What should I avoid while taking Guaifenex PPA 75 (guaifenesin and phenylpropanolamine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Guaifenesin and phenylpropanolamine may cause dizziness. If you experience dizziness, avoid these activities.

Guaifenex PPA 75 (guaifenesin and phenylpropanolamine) side effects

No serious side effects from guaifenesin and phenylpropanolamine are expected. Seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take guaifenesin and phenylpropanolamine and talk to your doctor if you experience

dizziness or headache;

nervousness, restlessness, or insomnia;

nausea or stomach upset; or

difficulty urinating.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Guaifenex PPA 75 (guaifenesin and phenylpropanolamine)?

Heart medications such as methyldopa (Aldomet), reserpine (Serpalan, Serpasil), and guanethidine (Ismelin) may have decreased effects. Talk to your doctor before taking guaifenesin and phenylpropanolamine if you are taking any of these medications.

Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking guaifenesin and phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain guaifenesin, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.

Drugs other than those listed here may also interact with guaifenesin and phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Guaifenex PPA 75 resources

Guaifenex PPA 75 Side Effects (in more detail)
Guaifenex PPA 75 Use in Pregnancy & Breastfeeding
Guaifenex PPA 75 Drug Interactions
Guaifenex PPA 75 Support Group
0 Reviews for Guaifenex PPA 75 - Add your own review/rating

Compare Guaifenex PPA 75 with other medications

Cough and Nasal Congestion

Where can I get more information?

Your pharmacist has additional information about guaifenesin and phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

Guaifenesin and phenylpropanolamine is available with a prescription under several brand names. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Entex LA, 400 mg of guaifenesin and 75 mg of phenylpropanolamine--orange, scored tablets

Exgest LA, 400 mg of guaifenesin and 75 mg of phenylpropanolamine--white, oval-shaped, scored, long-acting tablets with blue speckles

Dura-Vent, 600 mg of guaifenesin and 75 mg of phenylpropanolamine--white, scored tablets

See also: Guaifenex PPA 75 side effects (in more detail)

guanfacine

Generic Name: guanfacine (GWAHN fa seen)

Brand Names: Intuniv, Tenex

What is guanfacine?

Guanfacine reduces nerve impulses in your heart and blood vessels. Guanfacine works by relaxing blood vessels, which lowers blood pressure and improves blood flow.

Guanfacine is used to treat high blood pressure (hypertension). It is sometimes given together with other blood pressure medications.

Guanfacine is also used to treat attention deficit hyperactivity disorder (ADHD) in children who are at least 6 years old.

Guanfacine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about guanfacine?

You should not use this medication if you are allergic to guanfacine.

Before you take guanfacine, tell your doctor if you have heart disease, heart block, coronary artery disease or a history of stroke, low blood pressure, kidney or liver disease, or if you have recently had a heart attack.

Guanfacine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Avoid drinking alcohol.

To be sure this medication is helping your condition and not causing harmful effects, your doctor will need to check your progress on a regular basis. Your blood pressure and heart rate may also need to be checked. Do not miss any` follow-up visits to your doctor.

If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Tell your doctor if you regularly use other medicines that make you sleepy. They can add to sleepiness caused by guanfacine.

What should I discuss with my healthcare provider before taking guanfacine?

You should not use this medication if you are allergic to guanfacine.

To make sure you can safely take guanfacine, tell your doctor if you have any of these other conditions:

heart disease or heart block;

coronary artery disease or a history of stroke;

low blood pressure;

kidney disease;

liver disease; or

if you have recently had a heart attack.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether guanfacine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take guanfacine?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

If you take Intuniv to treat ADHD, take your dose in the morning.

If you take Tenex to treat hypertension, you may need to take your dose at bedtime if guanfacine causes severe drowsiness. Follow your doctor's instructions.

Do not crush, chew, or break an Intuniv extended-release tablet. Swallow the pill whole. Breaking the pill may cause too much of the drug to be released at one time.

If there are any changes in the brand, strength, or type of guanfacine you use, your dosage needs may change. Always check your refills to make sure you have received the correct brand and type of medicine prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.

Do not stop taking this medication without first talking to your doctor. If you stop taking guanfacine suddenly, your condition may become worse and you could have unpleasant symptoms.

Store at room temperature away from moisture, heat, and light.

See also: Guanfacine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Call your doctor for instructions if you miss more than 2 doses in a row.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include drowsiness, dizziness, slow heart rate, or feeling like you might pass out.

What should I avoid while taking guanfacine?

Avoid taking guanfacine with a high-fat meal.

Guanfacine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather while you are taking guanfacine.

Drinking alcohol can increase certain side effects of guanfacine.

Guanfacine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

fast or slow heart rate;

pounding heartbeats, chest tightness;

numbness or tingling; or

feeling like you might pass out.

Less serious side effects may include:

drowsiness, dizziness, tired feeling;

dry mouth;

constipation;

stomach pain;

weight gain;

headache; or

feeling irritable.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Guanfacine Dosing Information

Usual Adult Dose for Hypertension:

Initial dose: 1 mg orally once a day at bedtime, when given alone or in combination with another antihypertensive drug.
Maintenance dose: 1 to 3 mg orally once a day at bedtime.

Usual Pediatric Dose for Attention Deficit Disorder:

Only the guanfacine extended-release formulation is indicated for ADHD.

Children 6 to 17 years of age:

Initial dose: 1 mg extended-release orally once a day in the morning

Dosage should be adjusted in increments of no more than 1 mg/week.

Maintenance dose: 1 to 4 mg extended-release orally once daily in the morning, depending on clinical response and tolerability.

What other drugs will affect guanfacine?

Before you take guanfacine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, anxiety, or psychiatric disorders). They can add to sleepiness caused by guanfacine.

Tell your doctor about all other medications you use, especially any other blood pressure medications, or:

bosentan (Tracleer);

conivaptan (Vaprisol);

dexamethasone (Decadron, Hexadrol);

diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);

St. John's wort;

imatinib (Gleevec);

isoniazid (for treating tuberculosis);

valproic acid (Depakene, Stavzor);

an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), rifampin (Rifadin, Rifater, Rifamate), or telithromycin (Ketek);

antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);

an antidepressant such as nefazodone;

a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);

a calcium channel blocker such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

HIV or AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase), or ritonavir (Norvir); or

seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

This list is not complete and other drugs may interact with guanfacine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More guanfacine resources

Guanfacine Side Effects (in more detail)
Guanfacine Dosage
Guanfacine Use in Pregnancy & Breastfeeding
Drug Images
Guanfacine Drug Interactions
Guanfacine Support Group
53 Reviews for Guanfacine - Add your own review/rating

guanfacine Advanced Consumer (Micromedex) - Includes Dosage Information

Guanfacine Professional Patient Advice (Wolters Kluwer)

Guanfacine Prescribing Information (FDA)

Guanfacine Monograph (AHFS DI)

Guanfacine MedFacts Consumer Leaflet (Wolters Kluwer)

Intuniv Prescribing Information (FDA)

Intuniv Consumer Overview

Intuniv Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Tenex Prescribing Information (FDA)

Compare guanfacine with other medications

ADHD
High Blood Pressure

Where can I get more information?

Your pharmacist can provide more information about guanfacine.

See also: guanfacine side effects (in more detail)

Guaifenesin Granules

Pronunciation: gwye-FEN-eh-sin
Generic Name: Guaifenesin
Brand Name: Examples include Mucinex Children's and Mucinex Junior Strength

Guaifenesin Granules are used for:

Relieving symptoms of cough and mucus in the chest due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Guaifenesin Granules are an expectorant. It works by thinning mucus (phlegm) in the lungs and making it less sticky and easier to cough up. This reduces chest congestion by making coughs more productive.

Do NOT use Guaifenesin Granules if:

you are allergic to any ingredient in Guaifenesin Granules

Contact your doctor or health care provider right away if any of these apply to you.

Before using Guaifenesin Granules:

Some medical conditions may interact with Guaifenesin Granules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a persistent cough that occurs with smoking, asthma, chronic bronchitis, or emphysema, or if your cough occurs with large amounts of mucus

if you have phenylketonuria

Some MEDICINES MAY INTERACT with Guaifenesin Granules. Tell your health care provider if you are taking any other medicines. However, no specific interactions with Guaifenesin Granules are known at this time.

Ask your health care provider if Guaifenesin Granules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Guaifenesin Granules:

Use Guaifenesin Granules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Guaifenesin Granules by mouth with or without food.

Drinking extra fluids while you are taking Guaifenesin Granules are recommended. Check with your doctor for instructions.

Empty the entire contents of the packet onto the tongue and swallow. For best taste, do not chew before swallowing.

If you miss a dose of Guaifenesin Granules and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Guaifenesin Granules.

Important safety information:

If cough persists for more than 1 week or is accompanied by a fever, contact your health care provider. A persistent cough could be a sign of a serious condition.

Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.

Different brands of Guaifenesin Granules may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Guaifenesin Granules while you are pregnant. It is not known if Guaifenesin Granules are found in breast milk. If you are or will be breast-feeding while you use Guaifenesin Granules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Guaifenesin Granules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Guaifenesin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Guaifenesin Granules:

Store Guaifenesin Granules at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Guaifenesin Granules out of the reach of children and away from pets.

General information:

If you have any questions about Guaifenesin Granules, please talk with your doctor, pharmacist, or other health care provider.

Guaifenesin Granules are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Guaifenesin Granules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Guaifenesin resources

Guaifenesin Side Effects (in more detail)
Guaifenesin Use in Pregnancy & Breastfeeding
Drug Images
Guaifenesin Support Group
51 Reviews for Guaifenesin - Add your own review/rating

Compare Guaifenesin with other medications

Bronchitis
Cough
Fibromyalgia

Guaifenesin/Pseudoephedrine Controlled-Release Capsules

Pronunciation: gwye-FEN-ah-sin/sue-do-eh-FED-rin
Generic Name: Guaifenesin/Pseudoephedrine
Brand Name: Examples include Entex PSE and Nalex CR

Guaifenesin/Pseudoephedrine Controlled-Release Capsules are used for:

Relieving congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Guaifenesin/Pseudoephedrine Controlled-Release Capsules are a decongestant and expectorant combination. It works by constricting blood vessels, reducing swelling in the nasal passages, and thinning and loosening mucus in the airway. This allows you to breathe more easily and makes coughs more productive.

Do NOT use Guaifenesin/Pseudoephedrine Controlled-Release Capsules if:

you are allergic to any ingredient in Guaifenesin/Pseudoephedrine Controlled-Release Capsules

you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)

you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Guaifenesin/Pseudoephedrine Controlled-Release Capsules:

Some medical conditions may interact with Guaifenesin/Pseudoephedrine Controlled-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a fast, slow, or irregular heartbeat

if you have a history of adrenal gland problems (eg, tumor), heart problems, high blood pressure, diabetes, heart blood vessel problems, stroke, glaucoma, an enlarged prostate, seizures, or an overactive thyroid

if you have chronic cough

Some MEDICINES MAY INTERACT with Guaifenesin/Pseudoephedrine Controlled-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Guaifenesin/Pseudoephedrine Controlled-Release Capsules's side effects

Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

Bromocriptine because the risk of its side effects may be increased by Guaifenesin/Pseudoephedrine Controlled-Release Capsules

Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Guaifenesin/Pseudoephedrine Controlled-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Guaifenesin/Pseudoephedrine Controlled-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Guaifenesin/Pseudoephedrine Controlled-Release Capsules:

Use Guaifenesin/Pseudoephedrine Controlled-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Guaifenesin/Pseudoephedrine Controlled-Release Capsules by mouth with or without food.

Take Guaifenesin/Pseudoephedrine Controlled-Release Capsules with a full glass of water (8 oz/240 mL) unless your doctor tells you otherwise.

If you miss a dose of Guaifenesin/Pseudoephedrine Controlled-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Guaifenesin/Pseudoephedrine Controlled-Release Capsules.

Important safety information:

Guaifenesin/Pseudoephedrine Controlled-Release Capsules may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Guaifenesin/Pseudoephedrine Controlled-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not take appetite suppressants while you are taking Guaifenesin/Pseudoephedrine Controlled-Release Capsules without checking with your doctor.

Guaifenesin/Pseudoephedrine Controlled-Release Capsules has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.

Guaifenesin/Pseudoephedrine Controlled-Release Capsules may interfere with certain lab test results. Make sure that all of your doctors and lab personnel know that you are taking Guaifenesin/Pseudoephedrine Controlled-Release Capsules.

Tell your doctor or dentist that you take Guaifenesin/Pseudoephedrine Controlled-Release Capsules before you receive any medical or dental care, emergency care, or surgery.

Use Guaifenesin/Pseudoephedrine Controlled-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects.

Caution is advised when using Guaifenesin/Pseudoephedrine Controlled-Release Capsules in CHILDREN; they may be more sensitive to its effects.

PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Guaifenesin/Pseudoephedrine Controlled-Release Capsules, contact your doctor. You will need to discuss the benefits and risks of using Guaifenesin/Pseudoephedrine Controlled-Release Capsules while pregnant. It is not known if Guaifenesin/Pseudoephedrine Controlled-Release Capsules are found in breast milk. Do not breast-feed while taking Guaifenesin/Pseudoephedrine Controlled-Release Capsules.

Possible side effects of Guaifenesin/Pseudoephedrine Controlled-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor.

See also: Guaifenesin/Pseudoephedrine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Guaifenesin/Pseudoephedrine Controlled-Release Capsules:

Store Guaifenesin/Pseudoephedrine Controlled-Release Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Guaifenesin/Pseudoephedrine Controlled-Release Capsules out of the reach of children and away from pets.

General information:

If you have any questions about Guaifenesin/Pseudoephedrine Controlled-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.

Guaifenesin/Pseudoephedrine Controlled-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Guaifenesin/Pseudoephedrine Controlled-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Guaifenesin/Pseudoephedrine resources

Guaifenesin/Pseudoephedrine Side Effects (in more detail)
Guaifenesin/Pseudoephedrine Use in Pregnancy & Breastfeeding
Drug Images
Guaifenesin/Pseudoephedrine Drug Interactions
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Cough and Nasal Congestion

Guaifenex G

Generic Name: guaifenesin (Oral route)

gwye-FEN-e-sin

Commonly used brand name(s)

In the U.S.

Allfen

Altarussin

Amibid LA

Antitussin

Bidex 400

Diabetic Siltussin DAS-Na

Diabetic Tussin EX

Drituss G

Guaifenex G

Guaifenex LA

Mucinex

Robitussin

In Canada

Benylin-E

Benylin E Extra Strength Chest Congestion

Broncho-Grippex Expectorant

Robitussin Extra Strength

Available Dosage Forms:

Tablet, Extended Release

Solution

Capsule, Extended Release

Packet

Liquid

Tablet

Capsule

Elixir

Syrup

Therapeutic Class: Expectorant

Uses For Guaifenex G

Guaifenesin is used to help clear mucus or phlegm (pronounced flem) from the chest when you have congestion from a cold or flu. It works by thinning the mucus or phlegm in the lungs.

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Before Using Guaifenex G

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of guaifenesin in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults. However, check with your doctor before using this medicine in children who have a chronic cough, such as occurs with asthma, or who have an unusually large amount of mucus or phlegm with the cough. Children with these conditions may need a different kind of medicine. Also, guaifenesin should not be given to children and infants younger than 2 years of age unless you are directed to do so by your doctor.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of guaifenesin in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of guaifenesin

This section provides information on the proper use of a number of products that contain guaifenesin. It may not be specific to Guaifenex G. Please read with care.

Drinking plenty of water while taking guaifenesin may help loosen mucus or phlegm in the lungs.

For patients taking the extended-release capsule form of this medicine:

Swallow the capsule whole, or open the capsule and sprinkle the contents on soft food such as applesauce, jelly, or pudding and swallow without crushing or chewing.

For patients taking the extended-release tablet form of this medicine:

If the tablet has a groove in it, you may carefully break it into two pieces along the groove. Then swallow the pieces whole, without crushing or chewing them.

If the tablet does not have a groove, it must be swallowed whole. Do not break, crush, or chew it before swallowing.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For regular (short-acting) oral dosage forms (capsules, oral solution, syrup, or tablets):
- For cough:
  - Adults—200 to 400 milligrams (mg) every four hours.
  - Children 6 to 12 years of age—100 to 200 mg every four hours.
  - Children 4 to 6 years of age—50 to 100 mg every four hours.
  - Children and infants up to 4 years of age—Use is not recommended .

For long-acting oral dosage forms (extended-release capsules or tablets):
- For cough:
  - Adults—600 to 1200 mg every twelve hours.
  - Children 6 to 12 years of age—600 mg every twelve hours.
  - Children 4 to 6 years of age—300 mg every twelve hours.
  - Children and infants up to 4 years of age—Use is not recommended .

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Guaifenex G

If your cough has not improved after 7 days or if you have a fever, skin rash, continuing headache, or sore throat with the cough, check with your doctor. These signs may mean that you have other medical problems.

Guaifenex G Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare

Diarrhea

dizziness

headache

hives

nausea or vomiting

skin rash

stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Guaifenex G side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Guaifenex G resources

Guaifenex G Side Effects (in more detail)
Guaifenex G Use in Pregnancy & Breastfeeding
Drug Images
Guaifenex G Support Group
0 Reviews for Guaifenex G - Add your own review/rating

Allfen MedFacts Consumer Leaflet (Wolters Kluwer)

Guaifenesin Monograph (AHFS DI)

Guaifenesin Granules MedFacts Consumer Leaflet (Wolters Kluwer)

Guaifenesin NR Prescribing Information (FDA)

Hytuss Immediate-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Mucinex Prescribing Information (FDA)

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Bronchitis
Cough
Fibromyalgia

Guaifenesin-DM NR

Dosage Form: liquid
Guaifenesin-DM NR LIQUID

This product labeled for sale on prescription only.

Guaifenesin-DM NR Description

Guaifenesin-DM NR Liquid is a clear yellow liquid with a raspberry flavor.

Each 5 mL (1 teaspoonful) contains:

Guaifenesin 100 mg.

Dextromethorphan Hydrobromide 10 mg.

Other Ingredients: Citric Acid, D&C Yellow No. 10, FD&C Red No. 40, Glycerin, Methylparaben, Propylene Glycol, Raspberry Flavor, Saccharin Sodium, Sodium Benzoate, Sorbitol Solution, Water. It may contain Sodium Citrate. Guaifenesin (glyceryl guaiacolate) has the chemical name 3-(2-methoxyphenoxy)-1,2-propanediol. Its molecular formula is C10H14O4, with a molecular weight of 198.21. It is a white, colorless crystalline substance with a slightly bitter aromatic taste. One gram dissolves in 20 mL water at 25°C; freely soluble in ethanol. Guaifenesin is readily absorbed from the GI tract and is rapidly metabolized and excreted in the urine. Guaifenesin has a plasma halflife of one hour. The major urinary metabolite is beta-(2-methoxyphenoxy) lactic acid.

Guaifenesin-DM NR - Clinical Pharmacology

Guaifenesin-DM NR LIQUID combines the expectorant, guaifenesin and the cough suppressant, dextromethorphan hydrobromide. Guaifenesin is an expectorant, the action of which promotes or facilitates the removal of secretions from the respiratory tract. By increasing sputum volume and making sputum less viscous, guaifenesin facilitates expectoration of retained secretions. Dextromethorphan is a synthetic nonopioid cough suppressant, the dextro isomer of the codeine analogue of levorphanol. Dextromethorphan acts centrally to elevate the threshold for coughing, but does not have addictive, analgesic or sedative actions and does not produce respiratory depression with usual doses.

Indications and Usage for Guaifenesin-DM NR

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants. Calms the cough control center and relieves coughing. Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive.

Contraindications

Hypersensitivity to any of the ingredients. The use of dextromethorphan-containing products is contraindicated in patients receiving monoamine oxidase inhibitors (MAOIs).

Precautions

Carcinogenesis, Mutagenesis, Impairment of Fertility: Animal studies to assess the long-term carcinogenic and mutagenic potential or the effect on fertility in animals or humans of Guaifenesin-DM NR Liquid have not been performed.

Pregnancy

Teratogenic Effects-Pregnancy Category C: Animal reproduction studies have not been conducted. Safe use in pregnancy has not been established relative to possible adverse effects on fetal development. Therefore, this product should not be used in pregnant patients, unless in the judgment of the physician, the potential benefits outweigh possible hazards.

Nursing Mothers: It is not known whether guaifenesin or dextromethorphan is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when these products are administered to a nursing woman and a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Laboratory Test Interactions: Guaifenesin or its metabolites may cause color interference with the VMA (vanilylmandelic acid) test for catechols. It may also falsely elevate the level of urinary 5-HIAA (5-hydroxyindoleacetic acid) in certain serotonin metabolite chemical tests because of color interference.

Drug Interactions: Serious toxicity may result if dextromethorphan is coadministered with monoamine oxidase inhibitors (MAOIs). The use of dextromethorphan hydrobromide may result in additive CNS depressant effects when coadministered with alcohol, antihistamines, psychotropics or other drugs, which produce CNS depression.

Information for Patients: Patients should be warned not to use this product if they are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If patients are uncertain whether a prescription drug contains an MAOI, they should be instructed to consult a health professional before taking such a product.

Adverse Reactions

Guaifenesin is well tolerated and has a wide margin of safety. Nausea and vomiting are the side effects that occur most commonly. Other reported adverse reactions have included dizziness, headache and rash (including urticaria). Rare drowsiness or mild gastrointestinal disturbances are the only side effects associated with extromethorphan in clinical use. (see also Drug Interactions)

Overdosage

Overdosage with guaifenesin is unlikely to produce toxic effects since its toxicity is low. Guaifenesin, when administered by stomach tube to test animals in doses up to 5 grams/kg, produced no signs of toxicity. In severe cases of overdosage, treatment should be aimed at reducing further absorption of the drug. Gastric emptying (emesis and/or gastric lavage) is recommended as soon as possible after ingestion.

Overdosage with dextromethorphan may produce excitement and mental confusion. Very high doses may produce respiratory depression. One case of toxic psychosis (hyper-activity, marked visual and auditory hallucinations) after ingestion of a single 300 mg dose of dextromethorphan has been reported.

Guaifenesin-DM NR Dosage and Administration

Adults and children 12 years of age and older: 2 teaspoonfuls (10 ML) every four hours not to exceed 12

teaspoonfuls (60 ML) in 24 hours.

Children 6 years to under 12 years of age: 1 teaspoonful (5 ML) every four hours not to exceed 6 teaspoonfuls

(30 ML) in 24 hours.

Children 2 to under 6 years of age: 1/2 teaspoonful (2.5 ML) every four hours not to exceed 3 teaspoonfuls

(15 ML) in 24 hours.

Children under 2 years of age: Consult a physician.

How is Guaifenesin-DM NR Supplied

Guaifenesin-DM NR Liquid is available in bottles of 4 oz (118 mL), one pint (473 mL), and one gallon (3785 mL).

Store at controlled room temperature - 15°-30°C (59°-86°F).

Protect from light. Keep bottle tightly closed.

Manufactured by:

Silarx Pharmaceuticals, Inc.

Spring Valley, NY 10977

Guaifenesin-DM NR LIQUID
Guaifenesin-DM NR liquid liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	54838-124
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (Guaifenesin)	Guaifenesin	100 mg in 5 mL
Dextromethorphan Hydrobromide (Dextromethorphan)	Dextromethorphan Hydrobromide	10 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid
D&C Yellow No. 10
FD&C Red No. 40
glycerin
methylparaben
propylene glycol
saccharin sodium
sodium benzoate
sorbitol
water
sodium citrate

Product Characteristics
Color		Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	54838-124-80	473 mL In 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved other		05/01/2000

Labeler - Silarx Pharmaceuticals, Inc (161630033)

Revised: 05/2009Silarx Pharmaceuticals, Inc

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Guaifenesin-DM NR Side Effects (in more detail)
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Guaifenesin-DM NR Use in Pregnancy & Breastfeeding
Drug Images
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Guaifenesin-DM NR Support Group
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Cough
Expectoration

Guaifenesin/Hydrocodone

Pronunciation: gwye-FEN-e-sin/hye-droe-KOE-done
Generic Name: Guaifenesin/Hydrocodone
Brand Name: Examples include EndaCof-Tab and Ztuss ZT

Guaifenesin/Hydrocodone is used for:

Relieving cough and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Guaifenesin/Hydrocodone is a cough suppressant and expectorant combination. It works by loosening mucus and lung secretions in the chest, and making coughs more productive. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Guaifenesin/Hydrocodone if:

you are allergic to any ingredient in Guaifenesin/Hydrocodone or any other codeine or morphine-related medicine (eg, oxycodone)

you are taking sodium oxybate (GHB)

you have increased pressure in the brain, trouble breathing, or diarrhea due to antibiotic use

Contact your doctor or health care provider right away if any of these apply to you.

Before using Guaifenesin/Hydrocodone:

Some medical conditions may interact with Guaifenesin/Hydrocodone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a history of glaucoma, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, stroke, adrenal gland problems, or an underactive thyroid

if you have a history of stomach problems, bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent abdominal surgery

if you have breathing or lung problems (eg, asthma, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if cough occurs with large amounts of mucus

if you have recently had any head injury, brain injury or tumor, infection of the brain or nervous system, epilepsy, or seizures

if you have a history of alcohol abuse, drug abuse, or suicidal thoughts or behavior

Some MEDICINES MAY INTERACT with Guaifenesin/Hydrocodone. Tell your health care provider if you are taking any other medicines, especially any of the following:

Cimetidine because it may increase the risk of Guaifenesin/Hydrocodone's side effects

Barbiturates (eg, phenobarbital) or sodium oxybate (GHB) because the risk of severe drowsiness or breathing problems may be increased

Naltrexone because it may decrease Guaifenesin/Hydrocodone's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Guaifenesin/Hydrocodone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Guaifenesin/Hydrocodone:

Use Guaifenesin/Hydrocodone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Guaifenesin/Hydrocodone by mouth with or without food.

Drink plenty of water while taking Guaifenesin/Hydrocodone.

If you miss a dose of Guaifenesin/Hydrocodone, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Guaifenesin/Hydrocodone.

Important safety information:

Guaifenesin/Hydrocodone may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Guaifenesin/Hydrocodone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.

Guaifenesin/Hydrocodone may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Guaifenesin/Hydrocodone.

Tell your doctor or dentist that you take Guaifenesin/Hydrocodone before you receive any medical or dental care, emergency care, or surgery.

Use Guaifenesin/Hydrocodone with caution in the ELDERLY; they may be more sensitive to its effects.

Guaifenesin/Hydrocodone should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Guaifenesin/Hydrocodone while you are pregnant. It is not known if Guaifenesin/Hydrocodone is found in breast milk. Do not breast-feed while taking Guaifenesin/Hydrocodone.

Possible side effects of Guaifenesin/Hydrocodone:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; change in amount of urine; difficulty urinating; hearing change or loss; mental or mood changes; severe drowsiness.

See also: Guaifenesin/Hydrocodone side effects (in more detail)

If OVERDOSE is suspected:

Proper storage of Guaifenesin/Hydrocodone:

Store Guaifenesin/Hydrocodone at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Guaifenesin/Hydrocodone out of the reach of children and away from pets.

General information:

If you have any questions about Guaifenesin/Hydrocodone, please talk with your doctor, pharmacist, or other health care provider.

Guaifenesin/Hydrocodone is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Guaifenesin/Hydrocodone. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

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Guaifenesin/Hydrocodone Dosage
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Guaifenesin/Hydrocodone Drug Interactions
Guaifenesin/Hydrocodone Support Group
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Cough

Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour)

Pronunciation: gwye-FEN-e-sin/FEN-il-EF-rin
Generic Name: Guaifenesin/Phenylephrine
Brand Name: Examples include Gentex LA and Liquibid-D

Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) are used for:

Relieving symptoms of congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) are a decongestant and expectorant combination. It works by constricting blood vessels and shrinking swollen and congested nasal tissues (mucous membranes) and by thinning and loosening mucus in the airway. This allows you to breathe more easily and makes coughs more productive.

Do NOT use Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) if:

you are allergic to any ingredient in Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour)

you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems

you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour):

Some medical conditions may interact with Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a fast, slow, or irregular heartbeat

if you have a history of adrenal gland problems (eg, tumor), heart problems, high blood pressure, diabetes, heart blood vessel problems, stroke, glaucoma, an enlarged prostate, seizures, or an overactive thyroid

if you have chronic cough

Some MEDICINES MAY INTERACT with Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour). Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour)'s side effects

Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

Bromocriptine because the risk of its side effects may be increased by Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour)

Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour)

This may not be a complete list of all interactions that may occur. Ask your health care provider if Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour):

Use Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

Take Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) with a full glass of water (8 oz/240 mL) unless your doctor directs otherwise.

Swallow Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) whole. Do not break, crush, or chew before swallowing. Some brands of Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.

If you miss a dose of Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour), take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour).

Important safety information:

Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not take diet or appetite control medicines while you are taking Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) without checking with you doctor.

Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) has phenylephrine in it. Before you start any new medicine, check the label to see if it has phenylephrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.

If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.

Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour).

Tell your doctor or dentist that you take Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) before you receive any medical or dental care, emergency care, or surgery.

Use Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) with caution in the ELDERLY; they may be more sensitive to its effects.

Caution is advised when using Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) in CHILDREN; they may be more sensitive to its effects.

Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) while you are pregnant. Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) are found in breast milk. Do not breast-feed while taking Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour).

Possible side effects of Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour):

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor.

See also: Guaifenesin/Phenylephrine (12 Hour) side effects (in more detail)

If OVERDOSE is suspected:

Proper storage of Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour):

Store Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) out of the reach of children and away from pets.

General information:

If you have any questions about Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour), please talk with your doctor, pharmacist, or other health care provider.

Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour). If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) resources

Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) Side Effects (in more detail)
Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) Use in Pregnancy & Breastfeeding
Drug Images
Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) Drug Interactions
Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) Support Group
8 Reviews for Guaifenesin/Phenylephrine (12 Hour) - Add your own review/rating

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Cough and Nasal Congestion
Sinus Symptoms

Guanabenz

Dosage Form: tablet
Guanabenz Acetate Tablets USP

Rx only

Guanabenz Description

Guanabenz acetate USP, an antihypertensive agent for oral administration, is an aminoguanidine derivative. The chemical name for Guanabenz acetate USP is [(2,6-Dichlorobenzylidene)amino] guanidine monoacetate, and its structural formula is:

C8H8Cl2N4•C2H4O2 M.W. 291.14

It is an odorless, white to off-white, crystalline substance, sparingly soluble in water and soluble in alcohol. Each tablet of Guanabenz USP acetate is equivalent to 4 mg or 8 mg of free Guanabenz base. Guanabenz acetate USP, available as 4 mg or 8 mg tablets for oral administration, contains the following inactive ingredients: FD&C Blue #2 Aluminum Lake (8 mg only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, and ferric oxide.

Guanabenz - Clinical Pharmacology

Guanabenz acetate is an orally active central alpha-2 adrenergic agonist. Its antihypertensive action appears to be mediated via stimulation of central alpha adrenergic receptors, resulting in a decrease of sympathetic outflow from the brain at the bulbar level to the peripheral circulatory system.

Pharmacokinetics

In human studies, about 75% of an orally administered dose of Guanabenz acetate is absorbed and metabolized with less than 1% of unchanged drug recovered from the urine. Peak plasma concentrations of unchanged drug occur between two and five hours after a single oral dose. The average half-life for Guanabenz is about 6 hours. The site or sites of metabolism of Guanabenz have not been determined. The effect of meals on the absorption of Guanabenz acetate tablets has not been studied.

Pharmacodynamics

The onset of the antihypertensive action of Guanabenz begins within 60 minutes after a single oral dose and reaches a peak effect within two to four hours. The effect of an acute single dose is reduced appreciably six to eight hours after administration, and blood pressure approaches baseline values within 12 hours of administration.

The acute antihypertensive effect of Guanabenz occurs without major changes in peripheral resistance, but its chronic effect appears to be a decrease in peripheral resistance. A decrease in blood pressure is seen in both the supine and standing positions without alterations of normal postural mechanisms, so that postural hypotension has not been observed. Guanabenz decreases pulse rate by about 5 beats per minute. Cardiac output and left ventricular ejection fraction are unchanged during long-term therapy.

In clinical trials, Guanabenz acetate, given orally to hypertensive patients, effectively controlled blood pressure without any significant effect on glomerular filtration rate, renal blood flow, body fluid volume or body weight. Guanabenz given parenterally to dogs has produced a natriuresis. Similarly, hypertensive subjects, 24 hours after salt loading, have shown a decrease in blood pressure and a natriuresis (5% to 240% increase in sodium excretion) following a single oral dose of Guanabenz acetate. After seven consecutive days of administration and effective blood-pressure control, no significant change on glomerular filtration rate, renal blood flow, or body weight was observed. However, in clinical trials of six to thirty months duration, hypertensive patients with effective blood-pressure control by Guanabenz lost one to four pounds of body weight. The mechanism of this weight loss has not been established. Tolerance to the antihypertensive effect of Guanabenz has not been observed.

During long-term administration of guanabenz, there is a small decrease in serum cholesterol and total triglycerides without any change in the high-density lipoprotein fraction. Plasma norepinephrine, serum dopamine beta-hydroxylase and plasma renin activity are decreased during chronic administration of guanabenz. No changes in serum electrolytes, uric acid, bloodurea nitrogen, calcium, or glucose have been observed.

Guanabenz and hydrochlorothiazide have been shown to have at least partially additive effects in patients not responding adequately to either drug alone.

Indications and Usage for Guanabenz

Guanabenz acetate tablets are indicated in the treatment of hypertension. It may be employed alone or in combination with a thiazide diuretic.

Contraindications

Guanabenz acetate is contraindicated in patients with a known sensitivity to the drug or any of the tablet ingredients.

Precautions

General

1. Sedation: Guanabenz causes sedation or drowsiness in a large fraction of patients. When Guanabenz is used with centrally active depressants, such as phenothiazines, barbiturates, and benzodiazepines, the potential for additive sedative effects should be considered.

2. Patients with vascular insufficiency: Guanabenz, like other antihypertensive agents, should be used with caution in patients with severe coronary insufficiency, recent myocardial infarction, cerebrovascular disease, or severe hepatic or renal failure.

3. Rebound: Sudden cessation of therapy with central alpha agonists like Guanabenz may rarely result in “overshoot” hypertension and more commonly produces an increase in serum catecholamines and subjective symptomatology.

4. Patients with hepatic impairment: The disposition of orally administered Guanabenz acetate is altered in patients with alcohol-induced liver disease. Mean plasma concentrations of Guanabenz were higher in these patients than in healthy subjects. The clinical significance of this finding is unknown. However, careful monitoring of blood pressure is suggested when Guanabenz is administered to patients with hypertension and coexisting chronic hepatic dysfunction.

5. Patients with renal impairment: The disposition of orally administered Guanabenz acetate is altered modestly in patients with renal impairment. Guanabenz’s half-life is prolonged and clearance decreased, more so in patients on hemodialysis. The clinical significance of these findings is unknown. Careful monitoring of blood pressure during Guanabenz dose titration is suggested in patients with coexisting hypertension and renal impairment.

Information for Patients

Patients who receive Guanabenz should be advised to exercise caution when operating dangerous machinery or driving motor vehicles until it is determined that they do not become drowsy or dizzy from the medication. Patients should be warned that their tolerance for alcohol and other CNS depressants may be diminished. Patients should be advised not to discontinue therapy abruptly.

Laboratory Tests

In clinical trials, no clinically significant laboratory-test abnormalities were identified during either acute or chronic therapy with guanabenz. Tests carried out included CBC, urinalysis, electrolytes, SGOT, bilirubin, alkaline phosphatase, uric acid, BUN, creatinine, glucose, calcium, phosphorus, total protein, and Coombs’ test. During long-term administration of guanabenz, there was a small decrease in serum cholesterol and total triglycerides without any change in the high-density lipoprotein fraction. In rare instances an occasional nonprogressive increase in liver enzymes has been observed. However, no clinical evidence of hepatic disease has been found.

Drug Interactions

Guanabenz has not been demonstrated to cause any drug interactions when administered with other drugs, such as digitalis, diuretics, analgesics, anxiolytics, and antiinflammatory or antiinfective agents, in clinical trials. However, the potential for increased sedation when Guanabenz is administered concomitantly with CNS-depressant drugs should be noted.

Drug/Laboratory Test Interactions

No laboratory-test abnormalities were identified with the use of guanabenz.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Two-year studies were conducted with oral Guanabenz administered in the diet to mice and rats. No evidence of carcinogenic potential was seen in mice given doses of up to 11.5 mg/kg/day (41.4 mg/m2/day) or in rats given doses of up to 9.5 mg/kg/day (83.8 mg/m2/day). On a body-weight basis, these doses are 9X and 7X, respectively, the maximum recommended human daily dose (MRHDD) of 64 mg (based on a 50 kg individual). On a body-surface-area basis, these doses are 1X (mice) and 2X (rats) the MRHDD. In the Salmonella microsome mutagenicity (Ames) test system, Guanabenz at 200 to 500 mcg per plate or at 30 to 50 mcg/mL in suspension gave dose-related increases in the number of mutants in one (TA 1537) of five Salmonella typhimurium strains with or without inclusion of rat liver microsomes. No mutagenic activity was seen at doses up to those which inhibit growth in the eukaryotic microorganism, Schizosaccharomyces pombe, or in Chinese hamster ovary cells at doses up to those which were lethal to the cells in culture. In another eukaryotic system, Saccharomyces cerevisiae, Guanabenz produced no activity in an assay measuring induction of repairable DNA damage. Reproductive studies showed a decreased pregnancy rate in rats administered high oral doses (9.6 mg/kg) of Guanabenz acetate, suggesting an impairment of fertility. The fertility of treated males (9.6 mg/kg) may also have been affected, as suggested by the decreased pregnancy rate of their mates, even though the females received Guanabenz only during the last third of pregnancy.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Guanabenz ACETATE MAY HAVE ADVERSE EFFECTS ON THE FETUS WHEN ADMINISTERED TO PREGNANT WOMEN. A teratology study in mice has indicated a possible increase in skeletal abnormalities when Guanabenz acetate is given orally at doses of 3 to 6 times the maximum recommended human dose of 1 mg/kg. These abnormalities, principally costal and vertebral, were not noted in similar studies in rats and rabbits. However, increased fetal loss has been observed after oral Guanabenz acetate administration to pregnant rats (14 mg/kg) and rabbits (20 mg/kg). Reproductive studies of Guanabenz in rats have shown slightly decreased live-birth indices, decreased fetal survival rate, and decreased pup body weight at oral doses of 6.4 and 9.6 mg/kg. There are no adequate, well-controlled studies in pregnant women. Guanabenz should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Guanabenz is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of Guanabenz in pediatric patients have not been established.

Geriatric Use

Clinical studies of Guanabenz did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions

The incidence of adverse effects has been ascertained from controlled clinical studies conducted in the United States and is based on data from 859 patients who received Guanabenz for up to 3 years. There is some evidence that the side effects are dose-related.

The following table shows the incidence of adverse effects occurring in at least 5% of patients in a study comparing Guanabenz acetate to placebo, at a starting dose of 8 mg b.i.d.

Adverse Effect	Placebo (%) n=102	Guanabenz acetate (%) n=109
Dry mouth	7	28
Drowsiness or sedation	12	39
Dizziness	7	17
Weakness	7	10
Headache	6	5

In other controlled clinical trials at the starting dose of 16 mg/day in 476 patients, the incidence of dry mouth was slightly higher (38%) and that of dizziness was slightly lower (12%), but the incidence of the most frequent adverse effects was similar to the placebo-controlled trial. Although these side effects were not serious, they led to discontinuation of treatment about 15% of the time. In more recent studies using an initial dose of 8 mg/day in 274 patients, the incidence of drowsiness or sedation was lower, about 20%.

Other adverse effects were reported during clinical trials with Guanabenz but are not clearly distinguishable from placebo effects and occurred with a frequency of 3% or less:

Cardiovascular-chest pain, edema, arrhythmias, palpitations.

Gastrointestinal-nausea, epigastric pain, diarrhea, vomiting, constipation, abdominal discomfort.

Central nervous system-anxiety, ataxia, depression, sleep disturbances.

ENT disorders-nasal congestion.

Eye disorders-blurring of vision.

Musculoskeletal-aches in extremities, muscle aches.

Respiratory-dyspnea.

Dermatologic-rash, pruritus.

Urogenital-urinary frequency, disturbances of sexual function (decreased libido, impotence).

Other-gynecomastia, taste disorders.

In very rare instances atrioventricular dysfunction, up to and including complete AV block, has been caused by guanabenz.

Drug Abuse and Dependence

No reported dependence or abuse has been associated with the administration of guanabenz.

Overdosage

Accidental ingestion of Guanabenz caused hypotension, somnolence, lethargy, irritability, miosis, and bradycardia in two pediatric patients aged one and three years. Gastric lavage and administration of pressor substances, fluids, and oral activated charcoal resulted in complete and uneventful recovery within 12 hours in both patients.

Since experience with accidental overdosage is limited, the suggested treatment is mainly supportive while the drug is being eliminated from the body and until the patient is no longer symptomatic. Vital signs and fluid balance should be carefully monitored. An adequate airway should be maintained and, if indicated, assisted respiration instituted. There are no data available on the dialyzability of guanabenz.

Guanabenz Dosage and Administration

Dosage with Guanabenz acetate tablets should be individualized. A starting dose of 4 mg twice a day is recommended, whether Guanabenz acetate tablets are used alone or with a thiazide diuretic. Dosage may be increased in increments of 4 to 8 mg per day every one to two weeks, depending on the patient’s response. The maximum dose studied to date has been 32 mg twice daily, but doses as high as this are rarely needed.

How is Guanabenz Supplied

Guanabenz Acetate Tablets USP are available as peach, round, compressed tablets, debossed with company logo on one side and “4226” on the other side, containing Guanabenz acetate USP equivalent to 4 mg Guanabenz packaged in bottles of 100 tablets; and as grey, round, bisected compressed tablets, debossed with company logo on one side and “4227” on the other side, containing Guanabenz acetate USP equivalent to 8 mg Guanabenz packaged in bottles of 100 tablets.

PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Manufactured In Ireland By: 0172

IVAX PHARMACEUTICALS IRELAND 01/08

Waterford, Ireland B7

Manufactured For:

IVAX PHARMACEUTICALS, INC.

Miami, FL 33137

Distributed By:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text

NDC 0172-4226-60

Guanabenz ACETATE

Tablets USP

4 mg*

*Each tablet contains Guanabenz acetate, USP equivalent to 4 mg guanabenz

Rx only

100 TABLETS

TEVA

PRINCIPAL DISPLAY PANEL

Principal Display Panel

NDC 0172-4227-60

Guanabenz ACETATE

Tablets USP

8 mg*

*Each tablet contains Guanabenz acetate, USP equivalent to 8 mg guanabenz

Rx only

100 TABLETS

TEVA

Guanabenz ACETATE
Guanabenz acetate tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0172-4226
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guanabenz ACETATE (GUANABENZ)	Guanabenz ACETATE	4 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE

Product Characteristics
Color	ORANGE (peach)	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code	4226
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0172-4226-60	100 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074149	11/22/2010

Guanabenz ACETATE
Guanabenz acetate tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0172-4227
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guanabenz ACETATE (GUANABENZ)	Guanabenz ACETATE	8 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 2
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE

Product Characteristics
Color	GRAY	Score	2 pieces
Shape	ROUND	Size	6mm
Flavor		Imprint Code	4227
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0172-4227-60	100 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074149	11/22/2010

Labeler - Ivax Pharmaceuticals, Inc. (884075235)

Revised: 11/2010Ivax Pharmaceuticals, Inc.

More Guanabenz resources

Guanabenz Side Effects (in more detail)
Guanabenz Dosage
Guanabenz Use in Pregnancy & Breastfeeding
Drug Images
Guanabenz Drug Interactions
Guanabenz Support Group
1 Review for Guanabenz - Add your own review/rating

guanabenz Concise Consumer Information (Cerner Multum)

guanabenz Advanced Consumer (Micromedex) - Includes Dosage Information

Guanabenz MedFacts Consumer Leaflet (Wolters Kluwer)

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High Blood Pressure