Acetaminophen, Chlorpheniramine malaeate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride

FDA Drug Profile — Alka-Seltzer Plus Maximum Strength Cold and Cough Power Max Gels

Acetaminophen, Chlorpheniramine malaeate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Alka-Seltzer Plus Maximum Strength Cold and Cough Power Max Gels. Available dosage form: capsule, liquid filled.

Drug Details

Generic Name
Acetaminophen, Chlorpheniramine malaeate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
Brand Names
Alka-Seltzer Plus Maximum Strength Cold and Cough Power Max Gels
Application Number
M012
Sponsor
Bayer HealthCare LLC.
NDC Codes
1
Dosage Forms
CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients
CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN

Indications and Usage

Uses · temporarily relieves these symptoms due to a cold or flu: · minor aches and pains · headache · nasal and sinus congestion · sinus pressure · cough · sore throat · runny nose · sneezing · temporarily reduces fever

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take · more than 4,000 mg of acetaminophen in 24 hours · with other drugs containing acetaminophen · 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: · skin reddening · blisters · rash · hives · facial swelling · asthma (wheezing) · shock If a skin or general allergic 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. Do not use to sedate children.