Guaifenesin Syrup and Dextromethorphan

FDA Drug Profile — Guaifenesin Syrup and Dextromethorphan

Drug Details

Generic Name
Guaifenesin Syrup and Dextromethorphan
Brand Names
Guaifenesin Syrup and Dextromethorphan
Application Number
M012
Sponsor
Natco Pharma USA LLC
NDC Codes
2
Dosage Forms
SYRUP
Routes
ORAL
Active Ingredients
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

Indications and 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.

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)