IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]

IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]
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NDC 25000-135-03, 25000-135-14, 25000-135-30, 25000-135-93, 25000-135-98, 25000-136-03, 25000-136-14, 25000-136-30, 25000-136-93, 25000-136-98
Set ID 859d7190-586f-4766-a7e7-9e800a72d58b
Category Human OTC Drug Label
Packager MARKSANS PHARMA LIMITED
Generic Name
Product Class
Product Number
Application Number ANDA091237
  • Active ingredient(s)  


    Ibuprofen 200 mg (NSAID)*

      * nonsteroidal 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 allergic 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 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 or nonprescription 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 for longer than directed.  

  • Do not use


    • if you have ever had an allergic reaction to ibuprofen or 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 high blood pressure, heart disease, liver cirrhosis, or 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

  • Other required warnings

  • 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



  • Inactive ingredient(s)


    Silicon dioxide, croscarmellose sodium, FD & C yellow # 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide.

  • Storage

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


    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 Indl. Estate,
    Verna, Goa-403 722, India.

  • Principal Display Panel

    Ibuprofen Tablets, USP 200mg


    30 counts
    Bottle Label



    ibu-tab-30ct-bot-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-bot-label








    Ibuprofen Tablets, USP 200mg (Caplets)


    30 counts
    Carton Label



    ibu-cap-30ct-cart-label

    Ibuprofen Tablets, USP 200mg


    300 counts
    Bottle Label



    ibu-tab-300-bott-label


    Ibuprofen Tablets, USP 200mg


    1000 counts
    Bottle Label



    ibu-tab-1000-bott-label



    Ibuprofen Tablets, USP 200mg (Caplets)


    500 counts
    Bottle Label



    ibu-cap-500-bott-label


  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-135
    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)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeCAPSULE (Capsule Shaped) Size10mm
    FlavorImprint Code 120
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-135-0330 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2015
    2NDC:25000-135-141000 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2015
    3NDC:25000-135-306 in 1 BOX11/06/2015
    36500 in 1 BAG; Type 0: Not a Combination Product
    4NDC:25000-135-981 in 1 BOX11/06/2015
    434065 in 1 BAG; Type 0: Not a Combination Product
    5NDC:25000-135-931 in 1 BOX11/06/2015
    537470 in 1 BAG; Type 0: Not a Combination Product
    6NDC:25000-135-70500 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09123711/06/2015
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-136
    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)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUND (Round Shaped) Size15mm
    FlavorImprint Code 115
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-136-0330 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2015
    2NDC:25000-136-141000 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2015
    3NDC:25000-136-306 in 1 BOX11/06/2015
    36500 in 1 BAG; Type 0: Not a Combination Product
    4NDC:25000-136-981 in 1 BOX11/06/2015
    434065 in 1 BAG; Type 0: Not a Combination Product
    5NDC:25000-136-931 in 1 BOX11/06/2015
    537470 in 1 BAG; Type 0: Not a Combination Product
    6NDC:25000-136-69300 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2015
    7NDC:25000-136-711000 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09123711/06/2015
    Labeler - MARKSANS PHARMA LIMITED (925822975)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-135, 25000-136)

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