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 common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 Softgels in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.