DG Health Mucus ER

DG Health Mucus ER is an FDA drug label for the active ingredient GUAIFENESIN manufactured by Dolgencorp, LLC 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 20230406.

Generic: GUAIFENESIN

Manufacturer: Dolgencorp, LLC

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 55910-904

Application: ANDA078912

Effective: 20230406

Active Ingredients: Active ingredient (in each extended-release tablet) Guaifenesin 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 Ask a doctor before use if you have • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by too much phlegm (mucus) Stop use and ask a doctor if • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Adverse Reactions

Not available.

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