Label: IBUPROFEN - ibuprofen tablet

  • NDC Code(s): 25000-115-03, 25000-115-14, 25000-115-30, 25000-120-03, view more
    25000-120-14, 25000-120-30
  • Packager: MARKSANS PHARMA LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 11/12

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

  • Active ingredient(s)


    Ibuprofen 200 mg (NSAID)*

    ·        nonstreoidal anti-inflammatory drug

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  • Purpose


    Pain reliever / fever reducer Close
  • 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
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  • 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
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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


     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
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  • Ask a doctor or pharmacist before use if


    you are

    • taking any other drugs containg an NSAID (prescription or nonprescription)
    • taking a blood thining (anticoagulant) or steriod 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
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  • 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
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  • 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
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  • 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.

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  • Keep out of reach of children


    In case of overdose, get medical help or contact a PoisonControlCenter right away. Close
  • 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 docter
      (see Wanings)

             
    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

     
     
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  • Inactive ingredient(s)


    Microcrystalline sodium, Crosscarmellose Sodium, Pregelatinised starch, talc, Colloidal silicon dioxide, Magnesium stearate. Close
  • Storage

    • store between 20-25 0c (68-77 0 F).
    • do not use if seal under bottle cap imprinted with” SEALED for YOUR PROTECTION” is broken or missing.

     

    Manufactured for:


    Marksans Pharma Inc.

    3-Phillips Ln,
    Lake Grove, NY 11755, USA

    Manufactured by:

    Marksans Pharma Ltd.


    Plot No. L-82, L-83, Verna Indl. Estate,
    Verna, Goa-403 722, India.  Close
  • Principal Display Panel

    1000's count coated Tablets:

    Ibuprofen Tablets, USP 200mg


    (Round Shape)
     
    Ibuprofen round shape

     

    1000's count coated Tablets:

    Ibuprofen Tablets, USP 200mg


    (Caplet Shape)
     

    Ibuprofen capsule shape

     
     
      
     
     
     
     
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  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:25000-115
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code 115
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:25000-115-03 30 in 1 BOTTLE
    2 NDC:25000-115-14 1000 in 1 BOTTLE
    3 NDC:25000-115-30 6 in 1 BOX
    3 6500 in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091237 07/04/2012
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:25000-120
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 15mm
    Flavor Imprint Code 120
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:25000-120-03 30 in 1 BOTTLE
    2 NDC:25000-120-14 1000 in 1 BOTTLE
    3 NDC:25000-120-30 6 in 1 BOX
    3 6500 in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091237 07/04/2012
    Labeler - MARKSANS PHARMA LIMITED (925822975)
    Establishment
    Name Address ID/FEI Business Operations
    MARKSANS PHARMA LIMITED 925822975 MANUFACTURE(25000-115, 25000-120)
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