Acetaminophen,Dextromethrophan HBR

FDA Drug Profile — DayTime High Blood Pressure Cold and Flu Relief Liquid filled Softgels

Acetaminophen,Dextromethrophan HBR is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including DayTime High Blood Pressure Cold and Flu Relief Liquid filled Softgels. Available dosage form: capsule, liquid filled.

Drug Details

Generic Name
Acetaminophen,Dextromethrophan HBR
Brand Names
DayTime High Blood Pressure Cold and Flu Relief Liquid filled Softgels
Application Number
M012
Sponsor
AptaPharma Inc.
NDC Codes
1
Dosage Forms
CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE

Indications and Usage

Uses Temporarily relieves common cold/flu symptoms:

Warnings

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 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, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.