Acetaminophen and Ibuprofen

FDA Drug Profile — dual action pain reliever, Acetaminophen and Ibuprofen, Acetaminophen and Ibuprofen Back Pain, Motrin Dual Action With Tylenol, Aacetaminophen and Ibuprofen

Drug Details

Generic Name
Acetaminophen and Ibuprofen
Brand Names
dual action pain reliever, Acetaminophen and Ibuprofen, Acetaminophen and Ibuprofen Back Pain, Motrin Dual Action With Tylenol, Aacetaminophen and Ibuprofen, Acetaminophen 250 mg and Ibuprofen 125 mg
Application Number
ANDA216999
Sponsor
Aurobindo Pharma Limited
NDC Codes
29
Dosage Forms
TABLET, FILM COATED, TABLET
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, IBUPROFEN

Indications and Usage

Uses ■ temporarily relieves minor aches and pains due to: ■ headache ■ toothache ■ backache ■ menstrual cramps ■ muscular aches ■ minor pain of arthritis

Warnings

Acetaminophen liver damage warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ with other drugs containing acetaminophen ■ more than 6 caplets in 24 hours, which is the maximum daily amount for this product ■ 3 or more alcoholic drinks every day while using this product Acetaminophen allergy alert may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If skin reaction occurs, stop use and seek medical help right away. NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock ■ skin reddening ■ rash ■ blisters If an allergic reaction occurs, stop use and seek medical help right away NSAID stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: ■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.