Acetaminophen tablet extended release

FDA Drug Profile — Acetaminophen

Drug Details

Generic Name
Acetaminophen tablet extended release
Brand Names
Acetaminophen
Application Number
ANDA215486
Sponsor
Asclemed USA, Inc.
NDC Codes
3
Dosage Forms
TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients
ACETAMINOPHEN

Indications and Usage

Uses For Arthritis Pain temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever For Muscle Aches & Pains temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day 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.