Naproxen Sodium
FDA Label NDC 67060-000

ACTIVE INGREDIENT IN EACH TABLET-

Naproxen 200 mg

(naproxen 200 mg)(NSAID)*

*nonsteroidal anti-inflammatory drug

pain reliever/fever reducer

Uses: temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • menstrual cramps • headaches • toothache • temporarily reduces fever

Warnings:

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

Stomach Bleeding Warning: This product contains 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 a blood thinning (anticoagulant) or steroid drug • 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 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: • 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 are taking a diuretic • you have problems or serious side effects from taking pain relievers or fever reducers • you have asthma

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

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 for 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 specifically 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.

Directions: • do not use more than directed • the smallest effective dose should be used • drink a full glass of water with each dose

Adults and children 12 years of age and older:  • Take 1 tablet every 8 - 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.

Inactive Ingredients: FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, propylene glycol, povidone, talc, titanium dioxide