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 tablet) Ibuprofen 200 mg
(NSAID*)*nonsteroidal anti-inflammatory drug
Otc - Purpose
PurposePain reliever/fever reducer
Indications & Usage
- UsesTemporarily relieves minor aches and pains associated withheadachetoothachebackachemenstrual crampscommon coldmuscular achesminor arthritis painTemporarily reduces fever.
- WarningsAllergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- Hivesskin reddeningasthma (wheezing)acial swellingrashshockblistersIf 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 or 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 - Stop Use
- Do not useif you have ever had an allergic reaction to any other pain reliever/fever reducerright before or after heart surgeryAsk a doctor before use ifyou have problems or serious side effects from taking pain relievers or fever reducersstomach bleeding warning applies to youyou 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 diureticAsk a doctor or pharmacist before use if you aretaking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirinunder a doctor’s care for any serious conditiontaking any other drug When using this producttake with food or milk if stomach upset occursStop use and ask a doctor ifyou experience any of the following signs of stomach bleeding:feel faintvomit blood have bloody or black stoolshave stomach pain that does not get betteryou have symptoms of heart problems or strokechest paintrouble breathingweakness in one part or side of bodyslurred speechleg swellingpain gets worse or lasts for more than 10 daysfever gets worse or lasts for more than 3 daysredness or swelling is present in the painful areaany new or unexpected symptoms occurIf 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 specifically 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 use 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 older)
- Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used.
- Do not exceed 6 tablets in 24 hours, unless directed by a doctor.
- Children under 12 years:
- Do not give to children under 12 years of age.
Other Safety Information
- Other informationread all product information before usingstore at 68-77°F (20-25°C)avoid excessive heat 40°C (above 104°F)tamper evident sealed packetsdo not use any opened or torn packets
carnauba wax*, corn starch, hypromellose*, iron oxide red, lactose*, magnesium stearate*, microcrystalline cellulose*, polydextrose*,
polyethylene glycol, polyvinyl alcohol*, povidone K30*, silicon dioxide, sodium starch glycolate, stearic acid, talc*, titanium dioxide
Otc - Questions
* Please review the disclaimer below.