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Ibuprofen (Marksans Pharma Limited)

Available Formats

Dosage Form Package Information Links
TABLET 1000 TABLET in 1 BOTTLE (25000-114-14) Label Information
TABLET 4 BAG in 1 BOX (25000-114-20) > 6500 TABLET in 1 BAG Label Information
TABLET 6 BAG in 1 BOX (25000-114-30) > 6500 TABLET in 1 BAG Label Information
TABLET 30 TABLET in 1 BOTTLE (25000-114-03) Label Information

Complete Ibuprofen Information

  • Active ingredient(s)


    Ibuprofen 200 mg (NSAID)*

    * nonstreoidal anti-inflammatory drug


  • Purpose


    Pain reliever / fever reducer


  • Use(s)


    • temporarily relieves minor aches and pains 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 a NSAID, which may cause severe 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 drugs containing 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

    Heart attack and stroke warning: NSAID's except aspirin increases the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or longer than directed.  



  • Do not use


    • if you have ever had an allergic reaction to ibuprofen or 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
    • The stomach bleeding warning applies to you
    • You have a history of stomach problems, such as heartburn
    • You have a high blood pressure, heart disease,cirrhosis,kidney disease,asthma or had a stroke
    • You are taking a diuretic

     


  • Ask a doctor or pharmacist before use if you are


    • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    • under a doctor’s care for any serious condition
    • 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 stomach pain that does not get better
    • you have symptoms of heart problem 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
    • 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 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


    • 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.

  • Inactive ingredients

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

    Questions or Comments?

    Call 1-877-290-4008


     
    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 Industrial Estate
    Verna, Goa-403722, India  



  • Storage


  • Principal Display Panel

    Ibuprofen Tablets USP, 200mg


    30 counts
    Bottle Label



    ibu-tab-30ct-bott-label




    Ibuprofen Tablets USP, 200mg


    30 counts
    Carton Label



    ibu-tab-30ct-cart-label





    Ibuprofen Tablets USP, 200mg (Caplets)


    30 counts
    Bottle Label



    ibu-cap-30ct-bott-label




    Ibuprofen Tablets USP, 200mg (Caplets)


    30 counts
    Carton Label




    ibu-cap-30ct-cart-label




  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:25000-114
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    Color BROWN Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code 114
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:25000-114-03 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/25/2011
    2 NDC:25000-114-14 1000 in 1 BOTTLE; Type 0: Not a Combination Product 07/25/2011
    3 NDC:25000-114-20 4 in 1 BOX 07/25/2011
    3 6500 in 1 BAG; Type 0: Not a Combination Product
    4 NDC:25000-114-30 6 in 1 BOX 07/25/2011
    4 6500 in 1 BAG; Type 0: Not a Combination Product
    5 NDC:25000-114-98 1 in 1 BOX 07/25/2011
    5 34065 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091239 07/25/2011
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:25000-117
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    Color BROWN Score no score
    Shape CAPSULE Size 15mm
    Flavor Imprint Code 117
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:25000-117-03 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/25/2011
    2 NDC:25000-117-14 1000 in 1 BOTTLE; Type 0: Not a Combination Product 07/25/2011
    3 NDC:25000-117-20 4 in 1 BOX 07/25/2011
    3 6500 in 1 BAG; Type 0: Not a Combination Product
    4 NDC:25000-117-30 6 in 1 BOX 07/25/2011
    4 6500 in 1 BAG; Type 0: Not a Combination Product
    5 NDC:25000-117-98 1 in 1 BOX 07/25/2011
    5 34065 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091239 07/25/2011
    Labeler - MARKSANS PHARMA LIMITED (925822975)
    Establishment
    Name Address ID/FEI Business Operations
    MARKSANS PHARMA LIMITED 925822975 LABEL(25000-117) , MANUFACTURE(25000-114, 25000-117)