IBUPFROFEN

FDA Drug Profile — IBUPROFEN

Drug Details

Generic Name
IBUPFROFEN
Brand Names
IBUPROFEN
Application Number
ANDA091239
Sponsor
TIME CAP LABORATORIES,INC
NDC Codes
1
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
IBUPROFEN

Indications and Usage

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

Warnings

Warnings 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. 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.