Naproxen Sodium Tablet, Film Coated
FDA Label NDC 21130-856

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug

Pain reliever/fever reducer

• temporarily relieves minor aches and pains due to:
  
  • headache
  • muscular aches
  • the common cold
  • toothache
  • backache
  • menstrual cramps
  • minor pain of arthritis
  • temporarily reduces fever

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

• 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]
• are age 60 or older
• 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 are taking a diuretic
• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
• you have problems or serious side effects from taking pain relievers or fever reducers

• under a doctor’s care for any serious condition
  
• taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
  
• 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 stomach pain that does 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

ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

In case of overdose, get medical help or contact a Poison Control Center 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 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
  
• store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F)
  
• see end flap for expiration date and lot number
  

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

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

COMPARE TO
Aleve® Caplets
active ingredient^†

NDC 21130-856-52

Signature
care®
Quality
Guaranteed

Naproxen
Sodium
TABLETS, 220 mg
Pain Reliever/
Fever Reducer (NSAID)
Strength to last 12 hours

Actual Size

90 CAPLETS**
**CAPSULE-SHAPED TABLETS

TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING

^†This product is not manufactured or distributed by Bayer
HealthCare LLC, distributors of Aleve® Caplets.
50844   ORG122160452

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