Betr chest congestion relief

Betr chest congestion relief is an FDA drug label for the active ingredient GUAIFENESIN manufactured by Live Betr 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 20230222.

Generic: GUAIFENESIN

Manufacturer: Live Betr LLC

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 80267-002

Application: ANDA213420

Effective: 20230222

Active Ingredients: Active ingredient (in each extended-release tablet) Guaifenesin 1200 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 tablet every 12 hours. Do not exceed 2 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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