Country: United States
Language: English
Source: NLM (National Library of Medicine)
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
BJWC
ORAL
OTC DRUG
Pain reliever/Fever reducer - 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 - if you have ever had an allergic reaction to any other pain reliever/fever reducer - right before or after heart surgery - stomach bleeding warning applies to you - you have problems or serious side effects from taking pain relievers or fever reducers - you have a history of stomach problems, such as heartburn - you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke - you are taking a diuretic - 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 - 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 - you have sym
Abbreviated New Drug Application
IBUPROFEN- IBUPROFEN CAPSULE, LIQUID FILLED BJWC ---------- _DRUG FACTS_ _ACTIVE INGREDIENT (IN EACH CAPSULE)_ Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID) (present as the free acid and potassium salt) nonsteroidal anti-inflammatory drug _PURPOSE_ Pain reliever/Fever reducer _USES_ 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_ 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 be fatal. The risk is higher if you use more than directed or for longer than directed. 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 stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE under a doctor's care for any serious condition taking aspirin for heart at Read the complete document