Label: IBUPROFEN - ibuprofen tablet 

  • Label RSS
  • 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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 LABEL Item Code (Source) NDC:25000-115
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE  
    CROSCARMELLOSE SODIUM  
    STARCH, CORN  
    TALC  
    COLLOIDAL SILICON DIOXIDE  
    MAGNESIUM STEARATE  
    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 LABEL Item Code (Source) NDC:25000-120
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE  
    CROSCARMELLOSE SODIUM  
    STARCH, CORN  
    TALC  
    COLLOIDAL SILICON DIOXIDE  
    MAGNESIUM STEARATE  
    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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