Label: IBUPROFEN- ibuprofen tablet, coated
IBUPROFEN tablet, coated

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

Drug Label Information

Updated June 27, 2013

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  • Active ingredient(s)


    Ibuprofen 200 mg (NSAID)*

     * nonsteroidal anti-inflammatory drug


  • Purpose


    Pain reliever/Fever reducer


  • Use(s)

    temporarily relieves minor aches and pain due to:

    • backache
    • headache
    • menstrual cramps
    • minor pain of arthritis
    • muscular aches
    • the common cold
    • toothache
    • temporarily reduces fever
  • Warnings

    Allergy alert: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.

    Symptoms may include: 

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

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


    Stomach bleeding warning:     This product contains an 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 prescription or non prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • the 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
    • you have a history of stomach problems such as heartburn
    • the stomach bleeding warning applies to you
    • you have high blood pressure, heart disease , kidney disease, liver cirrhosis  
    • you are taking  a diuretic
    • you have asthma
  • 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 ibuprofen may decrease this benefit of aspirin
    • 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 occur

    Side effects occur. You may report side effects to PolyGen at 1-888-291-7337 and/ or FDA at 1-800-FDA-1088

  • Pregnancy/Breastfeeding


    ask a health professional before use. It is especially important not to use ibuprofen 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
    adults and children
    12 years and older:
    		· take 1 tablet every 4 to 6 hours while symptoms persist
    · if pain or fever does not respond to 1 tablet, 2 tablets may be used
    · do not exceed 6 tablets in 24 hours unless directed by a doctor
    children under 12 years:
    		ask a doctor
  • other information

    •  do not use if seal under cap is broken or missing
    • see end panel for lot number and expiration date


  • Inactive ingredient


    colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

  • Storage

    • store between 20-25 °C (68-77 ° F).
  • Questions


    1-888-291-7337


  • Principal Display Panel


    CARTON LABEL PDP

     

    NDC: 52605-114-01

     

    Compare to the active ingredient in Advil®

     

    IBUPROFEN TABLETS, USP 200 mg

    PAIN RELIEVER/ FEVER REDUCER (NSAID)

     

    100 COATED TABLETS

     

    SEE NEW WARNINGS INFORMATION
     


    Ibuprofen


    BOTTLE LABEL PDP

    NDC: 52605-114-01

     

    IBUPROFEN TABLETS, USP 200 mg

    PAIN RELIEVER/ FEVER REDUCER(NSAID)

     

    100 COATED TABLETS

     

    SEE NEW WARNINGS INFORMATION



    ibu200tabbottlab

    CARTON LABEL PDP

     

    NDC: 52605-117-01

     

    Compare to the active ingredient in Advil®

     

    IBUPROFEN TABLETS, USP 200 mg

    PAIN RELIEVER/ FEVER REDUCER (NSAID)

     

    100 COATED CAPLETS

     

    SEE NEW WARNINGS INFORMATION



    ibucarton100

    BOTTLE LABEL PDP

    NDC: 52605-117-01

     

    IBUPROFEN TABLETS, USP 200 mg

    PAIN RELIEVER/ FEVER REDUCER(NSAID)

     

    100 COATED CAPLETS

     

    SEE NEW WARNINGS INFORMATION



    ibubott100

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN  
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52605-114
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 114
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52605-114-011 in 1 CARTON
    1100 in 1 BOTTLE
    2NDC:52605-114-101000 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09123906/05/2012
    IBUPROFEN 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52605-117
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code 117
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52605-117-011 in 1 CARTON
    1100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09123906/05/2012
    Labeler - Polygen Pharmaceuticals LLC (962415720)
    Registrant - Polygen Pharmaceuticals LLC (962415720)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marksans Pharma Limited925822975MANUFACTURE(52605-117)
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