Label: NAPROXEN SODIUM - naproxen sodium tablet, coated

  • NDC Code(s): 52605-141-01, 52605-144-01, 52605-144-24
  • Packager: Polygen Pharmaceuticals LLC
  • 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 06/13

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

  • Active ingredient(s)


     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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  • Use(s)


    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
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  • Do not use

    •  if you have ever had an allergic reaction to any other pain reliever/fever reducer
    •  right before or after heart surgery
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  • 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 problems or serious side effects from taking pain relievers or fever reducers
    • you have asthma
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  • Ask a doctor or pharmacist before use if

    • under a doctor's care for any serious condition
    • taking any other drug
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  • 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
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  • Stop use and ask 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
    • 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
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  • Pregnancy/Breastfeeding


    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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  • 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
    • 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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  • Storage


    store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F).

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  • Other information

    • each tablet contains: sodium 20 mg
    • side effects occur. You may report side effects to PolyGen at 1-888-291-7337 and/ or FDA at 1-800-FDA-1088.
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  • Inactive ingredients


    colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone, titanium dioxide.

     

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  • Questions or comments


    1-800-291-7337


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  • Principal Display Panel



    NAPROXEN SODIUM TABLETS:
     

    Carton PDP:

    NDC: 52605-141-01

    Compare to the active ingredient in Aleve®

    ALL DAY PAIN RELIEF

    NAPROXEN SODIUM TABLETS, USP 220 mg

    PAIN RELIEVER/ FEVER REDUCER (NSAID)

     

    STRENGTH TO LAST 12 HOURS

    100 TABLETS



    Naproxensodium

    Bottle Label PDP:

    NDC: 52605-141-01

    ALL DAY PAIN RELIEF

    NAPROXEN SODIUM TABLETS, USP 220 mg

    PAIN RELIEVER/ FEVER REDUCER(NSAID)

     

    STRENGTH TO LAST 12 HOURS

    100 TABLETS



    Naproxensodiumtablets

    NAPROXEN SODIUM CAPLETS:
     

    Carton PDP:
     
    NDC: 52605-144-01
     
    Compare to the active ingredient in Aleve®
     
    ALL DAY PAIN RELIEF
    NAPROXEN SODIUM TABLETS, USP 220 mg
    PAIN RELIEVER/ FEVER REDUCER (NSAID)
     
    STRENGTH TO LAST 12 HOURS
     
    100 CAPLETS (CAPSULE- SHAPED TABLETS)
     
    Naproxensodium
     

    Bottle Label PDP:
     
    NDC: 52605-144-01
     
     
    ALL DAY PAIN RELIEF
    NAPROXEN SODIUM TABLETS, USP 220 mg
    PAIN RELIEVER/ FEVER REDUCER (NSAID)
     
    STRENGTH TO LAST 12 HOURS
     
    100 CAPLETS (CAPSULE- SHAPED TABLETS)
     
    Naproxensodiumcaplets 




    NAPROXEN SODIUM CAPLETS:
     

    Carton PDP:
     
    NDC: 52605-144-24
     
    Compare to the active ingredient in Aleve®
     
    ALL DAY PAIN RELIEF
    NAPROXEN SODIUM TABLETS, USP 220 mg
    PAIN RELIEVER/ FEVER REDUCER (NSAID)
     
    STRENGTH TO LAST 12 HOURS
     
    24 CAPLETS (CAPSULE- SHAPED TABLETS)



     naproxensodium24


    Bottle Label PDP:
     
    NDC: 52605-144-24
     
     
    ALL DAY PAIN RELIEF
    NAPROXEN SODIUM TABLETS, USP 220 mg
    PAIN RELIEVER/ FEVER REDUCER (NSAID)
     
    STRENGTH TO LAST 12 HOURS
     
    24 CAPLETS (CAPSULE- SHAPED TABLETS)



    naproxensodium24




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  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52605-141
    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
    COLLOIDAL SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    FD&C BLUE NO. 2  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POVIDONE  
    TITANIUM DIOXIDE  
    POLYETHYLENE GLYCOLS  
    Product Characteristics
    Color BLUE Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code 141
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52605-141-01 1 in 1 CARTON
    1 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090545 06/11/2012
    NAPROXEN SODIUM 
    naproxen sodium tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52605-144
    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
    CROSCARMELLOSE SODIUM  
    COLLOIDAL SILICON DIOXIDE  
    FD&C BLUE NO. 2  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POVIDONE  
    TITANIUM DIOXIDE  
    POLYETHYLENE GLYCOLS  
    Product Characteristics
    Color BLUE Score no score
    Shape OVAL Size 12mm
    Flavor Imprint Code 144
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52605-144-01 1 in 1 CARTON
    1 100 in 1 BOTTLE
    2 NDC:52605-144-24 1 in 1 CARTON
    2 24 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090545 11/13/2012
    Labeler - Polygen Pharmaceuticals LLC (962415720)
    Registrant - Polygen Pharmaceuticals LLC (962415720)
    Establishment
    Name Address ID/FEI Business Operations
    Marksans Pharma Limited 925822975 MANUFACTURE(52605-144)
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