Active Ingredient (in each Orange Tablet): Ibuprofen USP (200 mg). Inactive Ingredients: Carnauba Wax, Cellulose, Corn Starch, FD&C Yellow No. 6, Fumed Silica Gel, Hypromellose, Lactose, Magnesium Stearate, Polydextrose, Polyethylene Glycol, Sodium Starch Glycolate, Stearic Acid, Titanium Dioxide.
Do not take more than directed. The smallest effective dose should be used. Do not take longer than 10 days, unless directed by a doctor (see warnings). Adults and Children 12 Years and Over: 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: Ask a doctor. Store at controlled room temperature. Avoid excessive heat 40 degrees C (104 degrees F).
Wakefern Food Corporation
Elizabeth, NJ 07207
Allergy Alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing), rash, skin reddening, blisters, hives. If an allergic reaction occurs, stop use and seek medical help right away. Stomach Bleeding Warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you have had stomach ulcers or bleeding problems; take a blood thinning (anticoagulant) or steroid drug; are age 60 or older; have 3 or more alcoholic drinks every day while using this product; take other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or others]; take 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 reducer; right before or after heart surgery. Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers; stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain; bleeding problems; high blood pressure; ulcers; taken a diuretic; heart or kidney disease; reached age 60 or older. Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription); taking a blood thinning (anticoagulant) or steroid drug; taking any other drug; under a doctor's care for any serious condition. When using this product take with food or milk if stomach upset occurs; long term continuous use may increase the risk of heart attack or stroke. Stop use and ask a doctor if pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding; redness or swelling is present in the painful area; any new symptoms appear; stomach pain or upset gets worse or lasts. 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing.