DEXTROMETHORPHAN HYDROBROMIDE and HEXYLRESORCINOL

FDA Drug Profile — MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEF

Drug Details

Generic Name
DEXTROMETHORPHAN HYDROBROMIDE and HEXYLRESORCINOL
Brand Names
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEF
Application Number
M012
Sponsor
RB Health (US) LLC
NDC Codes
1
Dosage Forms
LOZENGE
Routes
ORAL
Active Ingredients
DEXTROMETHORPHAN HYDROBROMIDE, HEXYLRESORCINOL

Indications and Usage

Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold occasional irritation and pain due to a sore mouth or sore throat pain associated with canker sores

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 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. in children under 6 years of age When using this product do not exceed recommended dosage 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 sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling develops cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition. 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.