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 or slightly gray crystalline substance with a slightly bitter aromatic taste. One gram dissolves in 20 mL water at 25°C; it is 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 half-life of one hour. The major urinary metabolite is β-(2-methoxyphenoxy) lactic acid.

ORGANIDIN® NR (guaifenesin) is an expectorant available for oral administration as:

Tablets - each containing 200 mg guaifenesin, USP.

Other ingredients: Corn starch, croscarmel-lose sodium, FD&C Red No. 40, magnesium stearate, microcrystalline cellulose.

Liquid - each teaspoonful (5 mL) containing 100 mg guaifenesin, USP.

Other ingredients: Caramel, citric acid, flavor (raspberry), glycerin, propylene gly-col, purified water, saccharin sodium, sodium benzoate, sorbitol solution.

ORGANIDIN® NR: Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes and make coughs more productive. Helps loosen phlegm and thin bronchial secretions in patients with stable chronic bronchitis.

ORGANIDIN® NR (guaifenesin)

Tablets - Adults and children 12 years of age and older: One to 2 tablets (200 mg to 400 mg) every four hours, not to exceed 2400 mg (12 tablets) in 24 hours.

Liquid - Adults and children 12 years of age and older: Two to four teaspoonfuls (200 mg to 400 mg) every four hours, not to exceed 2400 mg (24 teaspoonfuls) in 24 hours.

Children 6 years to under 12 years of age: One to two teaspoonfuls (100 mg to 200 mg) every four hours, not to exceed 1200 mg (12 teaspoonfuls) in 24 hours.

Children 2 years to under 6 years of age: ½ to 1 teaspoonful (50 mg to 100 mg) every four hours, not to exceed 600 mg (6 teaspoonfuls) in 24 hours.

Children 6 mo. to under 2 years of age: A common dosage is 1/4 to ½ teaspoonful (25 mg to 50 mg) every four hours, not to exceed 300 mg (3 teaspoonfuls) in 24 hours. Individualized dosage should be determined by evaluation of patient.

PATIENTS SHOULD BE ADVISED TO KEEP THESE AND ALL DRUGS OUT OF THE REACH OF CHILDREN AND TO SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY IN CASE OF ACCIDENTAL OVERDOSE.

ORGANIDIN® NR (guaifenesin)

Tablets - Each round, scored, rose-colored tablet contains 200 mg guaifenesin USP-available in bottles of 100 (NDC 0037-4312-01)

Liquid - 100 mg guaifenesin per teaspoonful (5 mL) -available as a clear amber liquid in bottles of 1 pint (NDC 0037-4214-10)

STORAGE - Store at controlled room temperature 20°-25°C (68°-77°F). Protect tablets from moisture. Keep bottle tightly closed.

MedPointe Pharmaceuticals, somerset, New Jersey 08873. Rev. 11/06. FDA revision date: n/a

Guaifenesin is well tolerated and has a wide margin of safety. Side effects have been generally mild and infrequent. Nausea and vomiting are the side effects that occur most commonly. Dizziness, headache, and rash (including urticaria) have been reported rarely.

No information provided.

No information provided.

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 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, these products 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 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 (vanillylmandelic 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.

In massive overdosage the stomach should be emptied (emesis and/or gastric lavage) and further absorption prevented. Treatment is symptomatic and supportive.

The acute toxicity of guaifenesin is low and over-dosage is unlikely to produce serious toxic effects. In laboratory animals no toxicity resulted when guaifen-esin was administered by stomach tube in doses up to 5 grams/kg.

Hypersensitivity to any of the ingredients.

ORGANIDIN® NR (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.

No information provided. Please refer to the PRECAUTIONS section.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

GUAIFENESIN - ORAL

(gweye-FEN-eh-sin)

COMMON BRAND NAME(S): Guiatuss, Organidin NR, Robitussin

USES: This medication is used for the temporary relief of coughs caused by certain respiratory tract infections (e.g., common cold, sinusitis, bronchitis) and other breathing illnesses. This product is usually not used for ongoing cough from smoking or long-term breathing problems (e.g., chronic bronchitis, emphysema) unless directed by your doctor.

Guaifenesin belongs to a class of drugs known as expectorants. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier.

Do not use this medication in children younger than 2 years unless specifically directed by the doctor. To decrease the risk for serious side effects, carefully follow all of the doctor's dosage directions. Do not give other cough and cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask your doctor or pharmacist about other ways to relieve cough and cold symptoms (e.g., saline nose drops/spray, using a humidifier or infant nasal suction bulb).

HOW TO USE: Take this medication by mouth with or without food, usually every 4 hours or as directed by your doctor. Do not take more than 6 doses in a 24-hour period.

Drink plenty of fluids while taking this medication. Fluids will help to break up mucus and clear congestion.

Dosage is based on your medical condition and response to therapy.

For liquid forms, measure your dose with the dosing device provided with this medication. Do not use a household spoon.

Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day.

Inform your doctor if your condition persists or worsens after 7 days.

SIDE EFFECTS: Side effects from this medication are unlikely. If any bothersome side effects occur, notify your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking guaifenesin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., emphysema, chronic bronchitis, asthma), cough with large amounts of phlegm.

Liquid forms of this product may contain sugar and/or alcohol. Caution is advised if you have diabetes, alcohol dependence, or liver disease. Ask your doctor or pharmacist about the safe use of this product.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Guaifenesin is available in both prescription and nonprescription products. Check the labels of all your medications to make sure you are not taking more than one product containing guaifenesin.

This product can affect the results of certain lab tests (e.g., urine levels of certain acids). Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center. Symptoms of overdose may include: nausea, vomiting.

NOTES: Do not share this medication with others.

This medication is for temporary use only. Do not take this medication for more than 7 days unless your doctor tells you to do so. Tell your doctor if your condition lasts longer than 7 days.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Do not freeze liquid forms of this medication. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.