Acetaminophen 500mg

FDA Drug Profile — Pharbetol, Pain Relief Extra Strength, Acetaminophen, Acetaminophen 500mg ES, PHARBETOL

Drug Details

Generic Name
Acetaminophen 500mg
Brand Names
Pharbetol, Pain Relief Extra Strength, Acetaminophen, Acetaminophen 500mg ES, PHARBETOL
Application Number
M013
Sponsor
Ulai Health LLC
NDC Codes
6
Dosage Forms
TABLET, COATED, CAPSULE, COATED, TABLET, FILM COATED, TABLET
Routes
ORAL
Active Ingredients
ACETAMINOPHEN

Indications and Usage

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

Warnings

Warnings: Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4,000mg 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 reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If a skin reaction occurs, stop use and seek medical help right away. Do not use ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ new symptoms occur ■ redness or swelling is present. These could be signs of a serious condition If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.