Data from FDA - Curated by EPG Health - Last updated 27 July 2017

Indication(s)

INDICATIONS AND USAGE 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.

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Advisory information

contraindications
CONTRAINDICATIONS Hypersensitivity to any of the ingredients.
Special warnings and precautions
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 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.
Adverse reactions
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION 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. 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.
Pregnancy and lactation
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.

More information

Category Value
Agency product number 495W7451VQ
Orphan designation No
Product NDC 67046-250
Date Last Revised 06-10-2010
Type HUMAN PRESCRIPTION DRUG
RXCUI 197741
Storage and handling STORAGE — Store at controlled room temperature 20°-25°C (68°-77°F). Protect tablets from moisture. Keep bottle tightly closed. To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Qualitest PHARMACEUTICALS® Huntsville, AL 35811 8180142 Rev 5/08
Marketing authorisation holder Contract Pharmacy Services-PA