Active Ingredient (in each Tablet): Naproxen Sodium (220 mg) (Naproxen 200 mg) (NSAID - Nonsteroidal Anti-Inflammatory Drug). Inactive Ingredients: FD&C Blue No. 2 Lake, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Talc, 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). Drink a full glass of water with each dose. Adults and Children 12 Years and Older: Take 1 tablet every 8 to 12 hours while symptoms last. For the first dose you may take 2 tablets within the first hour. Do not exceed 2 tablets in any 8- to 12-hour period. Do not exceed 3 tablets in a 24-hour period. Children Under 12 Years: Ask a doctor. Store at 20-25 degrees C (68-77 degrees F). Avoid high humidity and excessive heat above 40 degrees C (104 degrees F).
Bayer HealthCare LLC
P.O. Box 1910 Morristown, NJ 07962-1910
Allergy Alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives; facial swelling; asthma (wheezing); shock; skin reddening; rash; blisters. 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: are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinning (anticoagulant) or steroid drug; take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others); have 3 or more alcoholic drinks ever day while using this product; 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; ulcers; bleeding problems; high blood pressure; heart or kidney disease; taken a diuretic; 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; under a doctor's care for any serious condition; taking any other drug. 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 you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; you have difficulty swallowing; it feels like the pill is stuck in your throat; you develop heartburn; stomach pain or upset gets worse or lasts; redness or swelling is present in the painful area; any new symptoms appear. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium 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. Do not use if carton is open or if foil seal imprinted with Safety Squease on bottle opening is missing or broken.