The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Distributed by:AAA Pharmaceutical, Inc.681 Main StreetLumberton, NJ 08048
Active Ingredient (In Each Caplet)
Ibuprofen, USP 200 mg (NSAIDnonsteroidal anti-inflammatory drug)
Pain reliever/fever reducer
- Temporarily relieves minor aches and pains due to:headachebackachethe common coldminor pain of arthritistoothachemenstrual crampsmuscular achestemporarily reduces fever
- Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:hivesshockfacial swellingskin reddeningasthma (wheezing)rashblistersIf 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 olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day while using this producttake more or for a longer time than directed
Do Not Use
- If you have ever had an allergic reaction to any other pain reliever/fever reducerright before or after heart surgery
Ask A Doctor Before Use If
- Stomach bleeding warning applies to youyou have problems or serious side effects from taking pain relievers or fever reducersyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthmayou are taking a diuretic
Ask A Doctor Or Pharmacist Before Use If You Are
- Under a doctor's care for any serious conditiontaking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirintaking any other drug
When Using This Product
- Take with food or milk if stomach upset occursthe risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop Use And Ask A Doctor If
- Side effects occur. You may report side effects to FDA at 1-800-FDA-1088.you experience any of the following signs of stomach bleeding:feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betterpain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysredness or swelling is present in the painful areaany new symptoms appear
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- Do not take more than directedthe smallest effective dose should be useddo not take longer than 10 days, unless directed by a doctor (see Warnings)adults and children 12 years and overtake 1 caplet every 4 to 6 hours while symptoms persistif pain or fever does not respond to 1 caplet, 2 caplets may be useddo not exceed 6 caplets in 24 hours, unless directed by a doctorchildren under 12 yearsask a doctor
- Store between 20°-25°C (68°-77°F)avoid excessive heat above 40°C (104°F)read all warnings and directions before useretain carton for complete product information
Colloidal silicon dioxide, corn starch, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone K30, pregelatinized starch, sodium carboxymellose, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin
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