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.
Otc - Active Ingredient
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
Otc - Purpose
Purpose Pain reliever/Fever reducer
Indications & Usage
- Uses temporarily relieves minor aches and pains due to:headachetoothachebackachemenstrual crampsthe common coldmuscular achesminor pain of arthritistemporarily reduces fever
- Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- Hivesfacial swellingasthma (wheezing)shockskin reddeningrashblistersIf 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 directedHeart 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.
Otc - Do Not Use
- Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducerright before or after heart surgery
Otc - Ask Doctor
- 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, asthma, or had a strokeyou are taking a diuretic
Otc - Ask Doctor/Pharmacist
- Ask a doctor or pharmacist before use if you areunder 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
Otc - When Using
- When using this producttake with food or milk if stomach upset occurs
Otc - Stop Use
- Stop use and ask a doctor if you experience any of the following signs of stomach bleeding:feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betteryou have symptoms of heart problems or stroke:chest paintrouble breathingweakness in one part or side of bodyslurred speechleg swellingpain 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
Dosage & Administration
- Directionsdo not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be used do not exceed 6 capsules in 24 hours, unless directed by a doctorchildren under 12 years: ask a doctor
Other Safety Information
- Other information each capsule contains:
- Potassium 20 mgread all warnings and directions before usestore at 20-25ºC (68-77ºF)avoid excessive heat above 40°C (104°F)
Inactive ingredients ammonium hydroxide, FD&C green no. 3, gelatin, iron oxide black, medium chain triglycerides, polyethylene glycol, potassium hydroxide, propylene glycol, purified water, shellac, sorbitan monooleate, sorbital sorbitan
Otc - Questions
* Please review the disclaimer below.