guaifenesin and dextromethorphan hydrobromide

FDA Drug Profile — Guaifenesin and Dextromethorphan Hydrobromide HBR

Drug Details

Generic Name
guaifenesin and dextromethorphan hydrobromide
Brand Names
Guaifenesin and Dextromethorphan Hydrobromide HBR
Application Number
ANDA214781
Sponsor
RITE-AID
NDC Codes
1
Dosage Forms
TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

Indications and 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

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. 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) When using this product do not use more than directed 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.