Guaifenesin Syrup and Dextromethorphan

GUAIFENESIN SYRUP AND DEXTROMETHORPHAN ORAL HUMAN OTC DRUG

Guaifenesin Syrup and Dextromethorphan is an FDA drug label for the active ingredient GUAIFENESIN SYRUP AND DEXTROMETHORPHAN manufactured by Natco Pharma USA 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 20231101.

Generic name: GUAIFENESIN SYRUP AND DEXTROMETHORPHAN
Manufacturer: Natco Pharma USA LLC
Product type: HUMAN OTC DRUG
Route: ORAL
Dosage form: N/A
NDC: 69339-149
Application: M012
Label effective: 20231101

Active ingredients

DRUG FACTS Active Ingredient (in each 5 mL cup) Purpose Guaifenesin, USP 100mg .............................................................................................................................. Expectorant Dextromethorphan HBr, USP 10mg ...................................................................................................... Cough Suppressant Active Ingredient (in each 10 mL cup) Purpose Guaifenesin, USP 200mg .............................................................................................................................. Expectorant Dextromethorphan HBr, USP 20mg .......................................................................................................Cough Suppressant Inactive Ingredients Anhydrous citric acid, dextrose, FD&C Red No. 40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate.

Indications & Usage

Uses • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Dosage & Administration

DIRECTIONS: Age Dose Adults and children 12 years and over 10 mL every 4 hours Max dose is 60mL in 24-hours Children under 12 years of age Ask a doctor

Contraindications

Not available.

Warnings

Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks after stopping the MAOI drug. Ask a doctor before use if you have • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema Ask a doctor or pharmacist before use if you are taking any other drug Stop use and ask a doctor if • your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. • you are hypersensitive to any of the ingredients 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.