Acetaminophen 160mg/5mL

FDA Drug Profile — Acetaminophen Oral Solution

Drug Details

Generic Name
Acetaminophen 160mg/5mL
Brand Names
Acetaminophen Oral Solution
Application Number
M013
Sponsor
Aldama Pharmaceuticals, Inc
NDC Codes
1
Dosage Forms
SOLUTION
Routes
ORAL
Active Ingredients
ACETAMINOPHEN

Indications and Usage

Uses Temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever

Warnings

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if: if adults takes more than 6 doses in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks everyday while using the 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.