Guaifenesin Extended-Release 600 mg

GUAIFENESIN ORAL HUMAN OTC DRUG

Guaifenesin Extended-Release 600 mg is an FDA drug label for the active ingredient GUAIFENESIN manufactured by Guardian Drug Company 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 20180228.

Generic name
GUAIFENESIN
Manufacturer
Guardian Drug Company
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
53041-233
Application
ANDA209215
Label effective
20180228

Active ingredients

ACTIVE INGREDIENT(in each extended-release tablet) Guaifenesin 600 mg

Indications & Usage

USE(S) 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

WARNING .

Adverse Reactions

Not available.

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