Guaifenesin
Guaifenesin is an FDA drug label for the active ingredient GUAIFENESIN manufactured by BluePoint Laboratories administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231212.
Generic: GUAIFENESIN
Manufacturer: BluePoint Laboratories
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 68001-561
Application: ANDA210453
Effective: 20231212
Active Ingredients: Active ingredient (in each extended-release tablet) Guaifenesin USP 600 mg
Indications & Usage
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Dosage & Administration
Directions do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours. children under 12 years of age: do not use
Contraindications
Not available.
Warnings
Warnings Do not use for children under 12 years of age
Adverse Reactions
Not available.
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