Guaifenesin and Dextromethorphan HBr
Guaifenesin and Dextromethorphan HBr is an FDA drug label for the active ingredient GUAIFENESIN AND DEXTROMETHORPHAN HBR manufactured by Aurohealth 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 20231201.
Generic: GUAIFENESIN AND DEXTROMETHORPHAN HBR
Manufacturer: Aurohealth LLC
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 58602-871
Application: ANDA206941
Effective: 20231201
Active Ingredients: Active ingredients (in each extended-release tablet) Dextromethorphan Hydrobromide USP 30 mg Guaifenesin USP 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 temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep
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 timing of meals adults and children 12 years and older: 1 or 2 tablets every 12 hours; not more than 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 if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Adverse Reactions
Not available.
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