SIMPEX Guaifenesin
SIMPEX Guaifenesin is an FDA drug label for the active ingredient GUAIFENESIN manufactured by Simpex Pharma Pvt. Ltd 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 20231129.
- Generic name
- GUAIFENESIN
- Manufacturer
- Simpex Pharma Pvt. Ltd
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 76457-004
- Application
- M012
- Label effective
- 20231129
Active ingredients
Indications & Usage
Uses helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus
Dosage & Administration
Directions adults & children 12 years of age and older : take a tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours. children under 12 years of age : do not use.
Contraindications
Not available.
Warnings
Warnings Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied with excessive phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days, recurs, or is accompanied with fever, rash, or persistent headache.These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.
Adverse Reactions
Not available.