Maximum Strength Non Drowsy Day and Night Cold and Flu

FDA Drug Profile — Maximum Strength Non Drowsy Day and Night Cold and Flu

Drug Details

Generic Name
Maximum Strength Non Drowsy Day and Night Cold and Flu
Brand Names
Maximum Strength Non Drowsy Day and Night Cold and Flu
Application Number
M012
Sponsor
WAL-MART STORES INC
NDC Codes
1
Dosage Forms
KIT
Routes
N/A
Active Ingredients
N/A

Indications and Usage

Uses Uses · temporarily relieves these symptoms due to a cold or flu: · minor aches and pains · headache · cough · sore throat · nasal and sinus congestion · temporarily reduces fever Directions Directions · do not take more than the recommended dose · adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor. · children under 12 years: do not use Uses Uses · temporarily relieves these symptoms due to a cold or flu: · minor aches and pains · headache · nasal and sinus congestion · 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. 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.