Country: United States
Language: English
Source: NLM (National Library of Medicine)
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
Pharmadel LLC
ORAL
OTC DRUG
Temporarily relieves minor aches and pains due to: - headache - muscular aches - minor pain of arthritis - toothache - backache - the common cold - menstrual cramps - temporarily reduces fever
Abbreviated New Drug Application
DOLEX FLEX- IBUPROFEN CAPSULE, LIQUID FILLED PHARMADEL LLC ---------- DOLEX FLEX (DEACTIVATED) DRUG FACTS ACTIVE INGREDIENT Active ingredient (in each capsule) Purpose Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*............... Pain reliever/fever reducer * nonsteroidal anti-inflammatory drug USES Temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever WARNINGS ALLERGY ALERT: IBUPROFEN may cause a severeallergic 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. 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 he Read the complete document