dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride

FDA Drug Profile

Drug Details

Generic Name
dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride
Brand Names
N/A
Application Number
Sponsor
Bayer HealthCare LLC.
NDC Codes
1
Dosage Forms
CAPSULE, LIQUID FILLED
Routes
N/A
Active Ingredients
ACETAMINOPHEN, 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 daily 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.