Active ingredient (in each caplet)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Uses
_ temporarily relieves minor aches and pains due to:
_ toothache _ muscular aches _ the common cold
_ headache _ menstrual cramps
_ backache _ minor pain of arthritis
_ temporarily reduces fever
Drug Facts (continued)
Warnings
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 _ hives
If 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 directed
Drug 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 directed
Drug 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
Directions
_ 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
Other information
_ 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 package
Drug Facts (continued)
