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.
Active Ingredient (In Each Caplet)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug
_ temporarily relieves minor aches and pains due to:_ toothache _ muscular aches _ the common cold_ headache _ menstrual cramps_ backache _ minor pain of arthritis_ temporarily reduces feverDrug Facts (continued)
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:_ asthma (wheezing) _ skin reddening _ shock_ blisters _ rash _ facial swelling _ hivesIf 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 older_ have had stomach ulcers or bleeding problems_ take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]_ have 3 or more alcoholic drinks every day while using this product_ take a blood thinning (anticoagulant) or steroid drug_ take more or for a longer time than directedDrug Facts (continued)
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
_ the stomach bleeding warning applies to you_ you have a history of stomach problems, such as heartburn_ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease _ you have asthma_ you have problems or serious side effects from taking pain relievers or fever reducers_ you are taking a diuretic
Ask A Doctor Or Pharmacist Before Use If You Are
_ 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_ the risk of heart attack or stroke may increase if you use more than directed or for longer than directedDrug Facts (continued)
Stop Use And Ask A Doctor If
_ you 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_ 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_ 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 (1-800-222-1222) right away.Drug Facts (continued)
_ do not take more than directed_ the smallest effective dose should be used_ drink a full glass of water with each dose_ adults and children 12 years and older take 1 caplet every 8 to 12 hours while symptoms last_ for the first dose you may take 2 caplets within the first hour_ do not exceed 2 caplets in any 8- to 12-hour period_ do not exceed 3 caplets in a 24-hour period_ children under 12 years: ask a doctor
_ each caplet contains: sodium 20 mg_ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN_ store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F)_ use by expiration date on packageDrug Facts (continued)
Croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide
* Please review the disclaimer below.