IBUPROFEN TABLET [POLYGEN PHARMACEUTICALS LLC]

IBUPROFEN TABLET [POLYGEN PHARMACEUTICALS LLC]
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NDC 52605-120-01
Set ID a5e2a7fd-dc7e-4f1b-9436-41b9834caaab
Category Human OTC Drug Label
Packager Polygen Pharmaceuticals LLC
Generic Name
Product Class
Product Number
Application Number ANDA091237
  • ACTIVE INGREDIENT(S)

    (each Caplet contains)

    Ibuprofen 200 mg (NSAID)*

    ·        Non-steroidal 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 alerts: 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:

    • are age 60 or older
    • have bad stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drug containing prescription NSAID (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
    • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
    • ulcers
    • bleeding problems
    • high blood pressure
    • heart or kidney disease
    • taken a diuretics
    • reached age 60 or older
  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF

    You are

    • taking any other drugs containing an NSAID (prescription or nonprescription)
    • taking a blood thinning (anticoagulant) or steroid drug
    • under a doctor’s care for any serious condition
    • taking aspirin for heart attacks 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
    • long term continuous use may increase the risk of heart attack or stroke
  • STOP USE AND ASK DOCTOR IF

    • You feel faint, vomit blood, or have bloody or black stools.

            These are signs of stomach bleeding.

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • stomach pain or upset gets worse or lasts
    • redness or swelling is present in painful area
    • any new symptoms appear
  • 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 a 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 PoisonControlCenter right away.

  • 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)

             

    adults and children 12 years and older
    • take 1 caplet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 caplet, 2 caplets may be used
    • do not exceed 6 caplets in 24 hours, unless directed by a doctor.
    Children under 12 years
    • ask a doctor
  • STORAGE

    • Store between 20-250C (68-770F).
    • do not use if seal under bottle cap is broken or missing.
  • INACTIVE INGREDIENTS

    Microcrystalline Cellulose, Croscarmellose Sodium, Pregelatinized starch, talc, Colloidal silicon dioxide, Magnesium stearate,polyvinyl Alcohol, Polyethylene glycol,Titanium dioxide.

  • PRINCIPAL DISPLAY PANEL

    Carton Label
    Thrulife
    NDC : 52605-120-01
    IBUPROFEN TABLETS, 200 mg
    PAIN RELIEVER/ FEVER REDUCER (NSAID)
    100 COATED CAPLETS
    CAPSULE SHAPED TABLETS

    ibu-white-cap-ctn




    Bottle label PDP
    Thrulife
    NDC:52605-120-01
    IBUPROFEN TABLETS USP, 200 mg
    PAIN RELIEVER/ FEVER REDUCER (NSAID)
    100 COATED CAPLETS
    CAPSULE SHAPED TABLETS

    ibu-white-cap-bot





  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52605-120
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code 120
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52605-120-011 in 1 CARTON
    1100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09123707/02/2013
    Labeler - Polygen Pharmaceuticals LLC (962415720)
    Registrant - Polygen Pharmaceuticals LLC (962415720)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marksans Pharma Limited925822975MANUFACTURE(52605-120)

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