Label: ALEVE- naproxen sodium tablet 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 05/11

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    ALL DAY STRONG®

    ALEVE®

    naproxen sodium tablets,

    220 mg (NSAID)

    Pain reliever/fever reducer

    STRENGTH TO LAST 12 HOURS

    CAPSULE-SHAPED TABLETS

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  • Active ingredient

    Drug Facts

    Active ingredient Purposes

    (in each caplet)

    Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* ..............................Pain reliever/fever reducer

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever/fever reducer

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  • Keep Out of Reach of Children

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control

    Center right away

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  • Uses

    Uses

    ■ temporarily relieves minor aches and pains due to:

    ■ minor pain of arthritis ■ muscular aches ■ backache ■ menstrual cramps ■ headache ■ toothache

    ■ the common cold

    ■ temporarily reduces fever

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  • Warnings

    Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to

    aspirin. Symptoms may include:

    ■ hives ■ asthma (wheezing) ■ skin reddening ■ blisters ■ facial swelling ■ shock ■ rash

    If an allergic reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID),

    which may cause 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 an NSAID (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

    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 you have

    ■ problems or serious side effects from taking pain relievers or fever reducers

    ■ stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain

    ■ ulcers ■ asthma

    ■ bleeding problems ■ high blood pressure

    ■ heart or kidney disease ■ taken a diuretic

    ■ reached age 60 or older

    Ask a doctor or pharmacist before use if you are

    ■ taking any other drug containing an NSAID (prescription or nonprescription)

    ■ taking a blood thinning (anticoagulant) or steroid drug

    ■ 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

    ■ the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

    Stop use and ask a doctor if

    ■ you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.

    ■ pain gets worse or lasts for more than 10 days

    ■ fever gets worse or lasts for more than 3 days

    ■ you have difficulty swallowing

    ■ it feels like the pill is stuck in your throat

    ■ you develop heartburn

    ■ stomach pain or upset gets worse or lasts

    ■ 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.

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  • Directions

    Directions

    ■ do not take more than directed

    ■ the smallest effective dose should be used

    ■ do not take longer than 10 days, unless directed by a doctor (see Warnings)

    ■ drink a full glass of water with each dose

    Adults and children 12 years ■ take 1 caplet every 8 to 12 hours while symptoms last

    and older ■ 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

    Other information

    ■ 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).

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  • Inactive Ingredients

    Inactive ingredients FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline

    cellulose, polyethylene glycol, povidone, talc, titanium dioxide

    Questions or comments?

    1-800-395-0689 (Mon - Fri 9AM - 5PM EST) or www.aleve.com

    Bayer, the Bayer Cross, Aleve and All Day Strong are registered trademarks of Bayer.

    US Pats. 4,948,002 and D330,677.

    Bayer HealthCare LLC

    Consumer Care

    P.O. Box 1910

    Morristown, NJ 07962-1910 USA

    MADE IN GERMANY

    Cardinal Health

    Zanesville, OH 43701

    IU40283610410

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  • Package/Label Principal Display Panel

    Aleve®

    (naproxen sodium) tablet

    220 mg (NSAID)

    Aleve
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  • Principal Display Panel - Label

    NDC 55154-4853-4

    Aleve®

    naproxen sodium tablets

    220 mg (NSAID)

    200 Caplets

    Label

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  • INGREDIENTS AND APPEARANCE
    ALEVE 
    naproxen sodium tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55154-4853(NDC:25866-001)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM 220 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 2  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOL 3350  
    POVIDONE  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color BLUE Score no score
    Shape OVAL Size 14mm
    Flavor Imprint Code ALEVE
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55154-4853-4 200 in 1 CARTON
    1 NDC:55154-4853-6 1 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020204 01/11/1994
    Labeler - Cardinal Health (188557102)
    Establishment
    Name Address ID/FEI Business Operations
    Cardinal Health 188557102 REPACK
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