Label: ALL DAY PAIN RELIEF- naproxen sodium tablet 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated 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 05/12

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

  • Active ingredient (in each tablet)

    Naproxen sodium 220 mg

    (naproxen 200 mg) (NSAID)*

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever/fever reducer

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  • 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
    • 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
    • take other drugs containing prescription or nonprescription NSAIDs (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

    • 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, or kidney disease
    • you are taking a diuretic
    • you have asthma

    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
    • 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 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
    • 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
    • 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. (1-800-222-1222)

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  • 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 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 any 8- to 12-hour period
    • do not exceed 3 tablets in a 24-hour period

    Children under 12 years

    • ask a doctor
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  • Other information

    • each tablet 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

    FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Strength to Last 12 Hours

    See New Warnings Information

    All Day Pain Relief

    Naproxen Sodium Tablets, 220 mg

    Pain Reliever & Fever Reducer (NSAID)

    Actual Size

    Compare to active ingredient of Aleve® Tablets

    Naproxen Sodium 220mg

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  • INGREDIENTS AND APPEARANCE
    ALL DAY PAIN RELIEF 
    naproxen sodium tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42254-230(NDC:0113-9490)
    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 GLYCOLS  
    POVIDONES  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color BLUE (Light Blue) Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code L490
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42254-230-14 14 in 1 BOTTLE
    2 NDC:42254-230-20 20 in 1 BOTTLE
    3 NDC:42254-230-30 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074661 01/14/1997
    Labeler - Rebel Distributors Corp (118802834)
    Registrant - PSS World Medical, Inc. (101822862)
    Establishment
    Name Address ID/FEI Business Operations
    PSS World Medical, Inc. 791528623 REPACK(42254-230)
    Establishment
    Name Address ID/FEI Business Operations
    STAT RX USA LLC 786036330 REPACK(42254-230)
    Establishment
    Name Address ID/FEI Business Operations
    Dispensing Solutions, Inc. 066070785 RELABEL(42254-230), REPACK(42254-230)
    Establishment
    Name Address ID/FEI Business Operations
    SCRIPT PAK 964420108 RELABEL(42254-230), REPACK(42254-230)
    Establishment
    Name Address ID/FEI Business Operations
    Keltman Pharmaceuticals, Inc. 362861077 REPACK(42254-230)
    Establishment
    Name Address ID/FEI Business Operations
    Rebel Distirbutors Corp. 118802834 RELABEL(42254-230), REPACK(42254-230)
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