Naproxen Tablet
FDA Label NDC 68071-5039

Naproxen sodium 220 mg
(Naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Pain reliever/ fever reducer

temporarily relieves minor aches and pain due to:

• backache
• muscular aches
• minor pain of arthritis
• menstrual cramps
• headache
• toothache
• the common cold

temporarily reduces fever

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 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 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.

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

• if you have ever had an allergic reaction to any other pain reliever / fever reducer
• right before or after heart surgery

• 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, kidney disease, asthma, or had a stroke
• you are taking a diuretic
• you have problems or serious side effects from taking pain relievers or fever reducers

• under a doctor's care for any serious condition
•   taking any other drug

• take with food or milk if stomach upset occurs

• you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have a stomach pain that dose not get better
  • you have symptoms of heart problems or stroke

   leg swelling  chest pain
   slurred speech  trouble breathing
   weakness in one part or side of body

  • 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.

• 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 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 ^oC (68-77 ^oF). Avoid high humidity and excessive heat above 40 ⁰C (104 ⁰F)

• each tablet contains: sodium 20 mg

croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl
alcohol, povidone, silicon dioxide, talc, titanium dioxide

Call 1-800-540-3765