Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine bitartrate, Doxylamine succinate

FDA Drug Profile — Alka-Seltzer Plus Cold Day and Night PowerMax gels

Drug Details

Generic Name
Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine bitartrate, Doxylamine succinate
Brand Names
Alka-Seltzer Plus Cold Day and Night PowerMax gels
Application Number
M012
Sponsor
Bayer HealthCare LLC.
NDC Codes
2
Dosage Forms
KIT
Routes
ORAL
Active Ingredients
N/A

Indications and Usage

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