acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate

FDA Drug Profile — NIGHTTIME CHERRY COLD AND FLU, Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime

Drug Details

Generic Name
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate
Brand Names
NIGHTTIME CHERRY COLD AND FLU, Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime
Application Number
M012
Sponsor
BETTER LIVING BRANDS LLC.
NDC Codes
2
Dosage Forms
LIQUID, CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE

Indications and Usage

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, 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.