NAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED]

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  • NAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED]

NAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED]
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NDC 25000-141-02, 25000-141-14, 25000-141-26, 25000-141-30, 25000-141-43, 25000-141-98, 25000-144-02, 25000-144-14, 25000-144-20, 25000-144-30, 25000-144-43, 25000-144-98
Set ID 48cb1363-ff12-40ee-a87a-2252dfbf8ff7
Category Human OTC Drug Label
Packager MARKSANS PHARMA LIMITED
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:
    • headache
    • minor pain of arthritis
    • muscular aches
    • backache
    • menstrual cramps
    • 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. 

    Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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, kidney disease, asthma or had a stroke
    • you are taking a diuretic
    • you have problems or serious side effects from taking pain relievers or fever reducers
  • Ask a doctor or pharmacist before use if

    • under a doctor's care for any serious condition
    • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
    • taking any other drug
  • When using this product

     

    • take with food or milk if stomach upset occurs

  • 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 a stomach pain that dose not get better
    • you have symptoms of heart problems or stroke
      • chest pain
      • trouble breathing
      • weakness in one part or side of body
      • slurred speech
      • leg swelling
    • 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
    • redness or swelling is present in the painful area
    • any new symptoms appear

  • Pregnancy/Breastfeeding


    ask 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.

  • 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 to12 hours while symptoms last
    • for 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 20-25oC (68-77oF). Avoid high humidity and excessive heat above 400C (1040F)
  • Other information

    • each tablet contains: sodium 20 mg

    Questions or comments?
    call toll free 1-877-376-4271


  • Inactive ingredients


    Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone,  titanium dioxide.

     

  • Manufactured for

    Time-Cap Labs, Inc.

    7 Michael Avenue,

    Farmingdale,

    NY 11735, USA

  • Manufactured by


    Marksans Pharma Ltd.

    Plot No.L-82, L-83, Verna Indl. Estate

    Verna, Goa – 403 722, India


    Mfg. Lic. No. GO/ Drugs/515

  • Principal Display Panel

    10s-Tablets-bottle-Label
    NDC 25000-141-43


    10s-tab-bottle



    10s-Tablets-bottle-Carton-Label
    NDC 25000-141-43


    10s-tab-carton



    24s-Tablets-bottle-Label
    NDC 25000-141-02


    24s-tab-bottle


    24s-Tablets-bottle-carton-Label
    NDC 25000-141-02


    24s-tab-carton


    1000s-Tablets-bottle-Label
    NDC 25000-141-14


    1000s-tab-bottle


    10s-oval-shaped-tablet-bottle-Label
    NDC 25000-144-43


    10s-cap-bottle


    10s-oval-shaped-tablet-bottle-carton-Label
    NDC 25000-144-43


    10s-cap-carton


    24s-oval-shaped-tablet-bottle-Label
    NDC 25000-144-02


    24s-cap-bottle


    24s-oval-shaped-tablet-bottle-carton-Label
    NDC 25000-144-02



    24s-cap-carton


    1000s-oval-shaped-tablet-bottle-Label
    NDC 25000-144-14



    1000s-cap-bottle
  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet, coated tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-144
    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
    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)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 144
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-144-141000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/04/2011
    2NDC:25000-144-204 in 1 BOX05/04/2011
    26500 in 1 BAG; Type 0: Not a Combination Product
    3NDC:25000-144-306 in 1 BOX05/04/2011
    36500 in 1 BAG; Type 0: Not a Combination Product
    4NDC:25000-144-02160 in 1 BOX05/04/2011
    41 in 1 CARTON
    424 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:25000-144-4310 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2011
    6NDC:25000-144-981 in 1 BOX05/04/2011
    632165 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09054505/04/2011
    NAPROXEN SODIUM 
    naproxen sodium, coated tablets tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-141
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 141
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-141-141000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/28/2011
    2NDC:25000-141-262 in 1 BOX05/28/2011
    21600 in 1 BAG; Type 0: Not a Combination Product
    3NDC:25000-141-306 in 1 BOX05/28/2011
    36500 in 1 BAG; Type 0: Not a Combination Product
    4NDC:25000-141-02160 in 1 BOX05/28/2011
    41 in 1 CARTON
    424 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:25000-141-4310 in 1 BOTTLE; Type 0: Not a Combination Product05/28/2011
    6NDC:25000-141-981 in 1 BOX05/28/2011
    632165 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09054505/28/2011
    Labeler - MARKSANS PHARMA LIMITED (925822975)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975API MANUFACTURE(25000-144) , MANUFACTURE(25000-141, 25000-144)
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