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Aleve Tablets, Caplets and Gelcaps (Bayer Healthcare)

  • Description
  • Indications and Usage
  • Warnings
  • Dosage and Administration
  • Description (2)
  • How Supplied

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  • Active Ingredient:                                 Purpose:

    (in each tablet/caplet/gelcap)

    Naproxen sodium 220 mg                        Pain reliever/fever reducer

      (naproxen 200 mg)

    Uses:    Temporarily relieves minor aches and pains due to:

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

    temporarily reduces fever

    Warnings: Allergy alert:    Naproxen sodium may cause a severe allergic reaction which may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

    Alcohol warning:    If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take naproxen sodium or other pain relievers/fever reducers. Naproxen sodium may cause stomach bleeding.

    Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer

    Ask a doctor before use if you have ever had serious side effects from any pain reliever/fever reducer

    Ask a doctor or pharmacist before use if you are

    • under a doctor's care for any serious condition
    • taking other drug
    • taking any other product that contains naproxen sodium, or any other pain reliever/fever reducer

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • 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
    • you develop heartburn
    • stomach pain occurs or lasts, even if symptoms are mild
    • 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 right away.


    • do not take more than directed
    • drink a full glass of water with each dose

    Adults and children
    12 years and older
    · take 1 tablet (caplet, gelcap) every 8 to 12 hours
       while symptoms last
    · for the first dose you may take 2 tablets (caplets,
       gelcaps) within the first hour
    · the smallest effective dose should be used
    · do not exceed 2 tablets (caplets, gelcaps) in any 8- to
       12-hour period
    · do not exceed 3 tablets (caplets, gelcaps) in a 24-hour
    Adults over 65 years
    · do not take more than 1 tablet (caplet, gelcap) every
       12 hours unless directed by a doctor
    Children under 12 years
    · ask a doctor

    Other Information:

    • each tablet (caplet, gelcap) contains: sodium 20 mg
    • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F)

    Aleve tablets, caplets:

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

    Aleve gelcaps:

    Inactive Ingredients:    D&C yellow #10 aluminum lake, edetate disodium, edible ink, FD&C blue #1, FD&C yellow #6 aluminum lake, gelatin, glycerin, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid, talc, titanium dioxide

    Questions or comments? call 1-800-395-0689 or

    * capsule-shaped tablet(s)
    ** gelatin coated capsule-shaped tablet(s)

    How Supplied:

    ALEVE® Caplets in boxes of 24, 50, 100, 150, 200.

    ALEVE® Gelcaps in boxes of 20, 40, 80.

    ALEVE® Tablets in boxes of 24, 50, 100, 150. + 8 count vials

    Distributed by

    Bayer HealthCare LLC

    PO Box 1910

    Morristown, NJ 07962-1910 USA

    B-R LLC

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    This page was last modified 30-JUN-07
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