Guaifenesin Extended Release
Guaifenesin Extended Release is an FDA drug label for the active ingredient GUAIFENESIN manufactured by SAM'S WEST INC 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 20220624.
- Generic name
- GUAIFENESIN
- Manufacturer
- SAM'S WEST INC
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 68196-996
- Application
- ANDA209254
- Label effective
- 20220624
Active ingredients
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 extended-release 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 extended-release tablet every 12 hours. Do not exceed 2 extended-release 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.