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Generic: naproxen sodium is used for the treatment of Arthritis, Juvenile Arthritis, Rheumatoid Back Pain Bursitis Common Cold Dysmenorrhea Fever Gout Headache Inflammation Osteoarthritis Pain Pregnancy Trimester, Third Spondylitis, Ankylosing Toothache


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Active Ingredient (in Each Tablet)


Naproxen sodium 220 USP, mg (naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes


Pain reliever/fever reducer

Uses

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

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

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, 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
  • 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



Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • have bloody or black stools
    • feel faint
    • vomit blood
    • have stomach pain that does not get better
  • you have symptoms of heart problem or stroke:
    • chest pain
    • trouble breathing
    • slurred speech
    • leg swelling
    • 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
  • 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

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.

Directions

  • do not make 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 a any 8- to 12-hour period
    • do not exceed 3 tablets in a 24-hour period
  • children under 12 years: ask a doctor 

Other Information

  • each tablet contains: sodium 20 mg
  • store at 20Âș to 25ÂșC (68Âș to 77ÂșF). Avoid high humidity and excessive heat above 40ÂșC (104ÂșF). Protect from light.



Inactive Ingredients


croscarmellose sodium, FD&C blue # 2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide

Questions Or Comments?


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

Principal Display Panel


Compare to the active ingredient in Aleve¼†

All Day Pain Relief

Naproxen sodium tablets,

(NSAID) 220 mg

pain reliever/fever reducer

strength to last 12 hours

Tablets

†This product is not manufactured or distributed by Bayer Healthcare, LLC, distributor Aleve¼.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Package Labeling

READYinCASE All Day Pain Relief

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