Dextromethorphan hydrobromide and Phenylephrine hydrochloride

FDA Drug Profile — Childrens SUDAFED PE Cold plus Cough

Drug Details

Generic Name
Dextromethorphan hydrobromide and Phenylephrine hydrochloride
Brand Names
Childrens SUDAFED PE Cold plus Cough
Application Number
M012
Sponsor
Kenvue Brands LLC
NDC Codes
1
Dosage Forms
SOLUTION
Routes
ORAL
Active Ingredients
DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses Temporarily relieves these symptoms due to hay fever (allergic rhinitis): cough due to minor throat and bronchial irritation runny nose sneezing itchy, watery eyes itching of the nose or throat Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis. Temporarily restores freer breathing through the nose

Warnings

Warnings Do not use to sedate a child or make a child sleepy 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 drug.