Naproxen Sodium Capsule
FDA Label NDC 59726-751

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
  • minor pain of arthritis
  • toothache
  • backache
  • the common cold
  • menstrual cramps
  • 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
• have 3 or more alcoholic drinks every day while using this product
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• 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 have problems or serious side effects from taking pain relievers or fever reducers
• you are taking a diuretic

• 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
  • have bloody or black stools
  • vomit blood
  • have stomach pain that does not get better
  • you have symptoms of heart problem or stroke:
    • chest pain
    • slurred speech
    • leg swelling
    • trouble breathing
    • weakness in one part or side of the body
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present in the painful area
    • any new symptoms appear
    • you have difficulty swallowing
    • it feels like the pill is stuck in your throat

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.

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
• if taken with food, this product may taken longer to work
• adults and children 12 years and older:
  • take 1 capsule 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

• each tablet contains: sodium 20 mg
• store at 20° to 25°C (68° to 77°F), excursions permitted between 15°C and 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Avoid high humidity and excessive heat above 40°C (104°F). Protect from light. 
• read all direction and warnings before use. Keep carton.
• swallow whole: do not crush, chew or dissolve

FD&C blue #1, gelatin, glycerin, lactic acid, polyethylene glycol, sorbitan, sorbitol, white pharmaceutical ink

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

†Compare to the active ingredient in Aleve® Liquid Gels

all day pain relief

Naproxen Sodium

capsules 220 mg

pain reliever / fever reducer (NSAID)

strength to last 12 hours

liquid gels**

(**liquid-filled capsules)

††This product is not manufactured or distributed by Bayer Healthcare, LLC, distributor of Aleve® Liquid Gels.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590