NAPROXEN SODIUM TABLET, COATED [POLYGEN PHARMACEUTICALS LLC]

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NAPROXEN SODIUM TABLET, COATED [POLYGEN PHARMACEUTICALS LLC]
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NDC 52605-141-01, 52605-144-01, 52605-144-24
Set ID e8720904-9ac0-46c0-b220-730e373505a7
Category Human OTC Drug Label
Packager Polygen Pharmaceuticals LLC
Generic Name
Product Class
Product Number
Application Number ANDA090545
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  • Active ingredient(s)


     Naproxen Sodium 220 mg (naproxen 200 mg) (NSAID)*

     *nonsteroidal anti-inflammatory drug

  • Purpose


    Pain reliever/Fever reducer 


  • 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
  • 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 problems or serious side effects from taking pain relievers or fever reducers
    • you have asthma
  • Ask a doctor or pharmacist before use if

    • 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 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
  • 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.

  • 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).

  • 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
  • Storage


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

  • 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.
  • Inactive ingredients


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

     

  • Questions or comments


    1-800-291-7337


  • 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

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52605-141
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
    Inactive Ingredients
    Ingredient NameStrength
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 141
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52605-141-011 in 1 CARTON
    1100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09054506/11/2012
    NAPROXEN SODIUM 
    naproxen sodium tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52605-144
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 144
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52605-144-011 in 1 CARTON
    1100 in 1 BOTTLE
    2NDC:52605-144-241 in 1 CARTON
    224 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09054511/13/2012
    Labeler - Polygen Pharmaceuticals LLC (962415720)
    Registrant - Polygen Pharmaceuticals LLC (962415720)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marksans Pharma Limited925822975MANUFACTURE(52605-144)
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