Acetaminophen, Dextromethrophan HBr, Doxylamine succinate

FDA Drug Profile — Nighttime Cold and Flu

Acetaminophen, Dextromethrophan HBr, Doxylamine succinate is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including Nighttime Cold and Flu. Available dosage form: liquid.

Drug Details

Generic Name
Acetaminophen, Dextromethrophan HBr, Doxylamine succinate
Brand Names
Nighttime Cold and Flu
Application Number
M012
Sponsor
Kroger
NDC Codes
2
Dosage Forms
LIQUID
Routes
ORAL
Active Ingredients
DOXYLAMINE SUCCINATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE

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

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 Liquicaps 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. Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 Liquicaps 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.