dextromethorphan hydrobromide, menthol

FDA Drug Profile — Robitussin Medi-Soothers

Drug Details

Generic Name
dextromethorphan hydrobromide, menthol
Brand Names
Robitussin Medi-Soothers
Application Number
M012
Sponsor
Haleon US Holdings LLC
NDC Codes
2
Dosage Forms
LOZENGE
Routes
ORAL
Active Ingredients
DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL, UNSPECIFIED FORM

Indications and Usage

Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold occasional minor irritation, pain, sore mouth, and sore throat

Warnings

Warnings Sore throat warning if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly Do Not Use if you are now taking 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, or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor or dentist if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens 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. Sore throat warning if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly