Acetaminophen, Dextromethorphan, Doxylamine succinate

FDA Drug Profile — Nighttime Cold and Flu Liquid Cherry, Nighttime Cold and Flu

Drug Details

Generic Name
Acetaminophen, Dextromethorphan, Doxylamine succinate
Brand Names
Nighttime Cold and Flu Liquid Cherry, Nighttime Cold and Flu
Application Number
M012
Sponsor
Grimann, S.A. de C.V.
NDC Codes
3
Dosage Forms
LIQUID
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE

Indications and Usage

Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose and sneezing

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses 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 skin reaction occurs, stop use and seek medical help right away Sore throat warning: If sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.