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 caplet)
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Otc - Purpose
Pain reliever/Fever reducer
Indications & Usage
- Usestemporarily relieves minor aches and pains due to:backache
- Menstrual cramps
- Minor pain of arthritis
- Muscular aches
- The common cold
- Temporarily reduces fever
- WarningsAllergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
- Symptoms may include:
- Asthma (wheezing)blistersfacial swellinghivesrashshockskin reddeningIf 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 useif you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducerright before or after heart surgery
Otc - Ask Doctor
- Ask 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 diuretic
Otc - Ask Doctor/Pharmacist
- Ask 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
Otc - When Using
- When using this producttake with food or milk if stomach upset occurs
Otc - Stop Use
- Stop use and ask a doctor ifyou 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 symptoms of heart problem or stroke:chest pain
- Trouble breathing
- Weakness in one part or side of the body
- Slurred speech
- Leg swelling
- Pain 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 (1-800-222-1222).
Dosage & Administration
- Directionsdo not take more than directedthe smallest effective dose should be usedadults and children 12 years and over:take 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 under12 years:ask a doctor
- Other informationread all warnings and directions before usestore at 20-25°C (68-77°F)
Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide
Otc - Questions
Questions or comments? Call 1-800-632-6900
* Please review the disclaimer below.