Ibuprofen 200mg

FDA Drug Profile — Ibuprofen 200mg, Physicians Care Ibuprofen, Redicare Ibuprofen 200mg

Drug Details

Generic Name
Ibuprofen 200mg
Brand Names
Ibuprofen 200mg, Physicians Care Ibuprofen, Redicare Ibuprofen 200mg
Application Number
ANDA072096
Sponsor
Southern Sales & Services, Inc.
NDC Codes
8
Dosage Forms
TABLET, FILM COATED, TABLET, TABLET, COATED
Routes
ORAL
Active Ingredients
IBUPROFEN

Indications and Usage

Use(s) temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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. Contains FD&C Yellow No. 5 (tartrazine) as a color additive. Do not use if you have ever had an allergic reaction to any other pain reliever/ fever reducer right before or after heart surgery Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if under a doctor’s care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better If pregnant or breastfeeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.