IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]

IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]
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NDC 25000-114-03, 25000-114-14, 25000-114-20, 25000-114-30, 25000-114-93, 25000-114-98, 25000-117-03, 25000-117-14, 25000-117-20, 25000-117-30, 25000-117-93, 25000-117-98
Set ID 3c8df1e5-61bc-4e70-b6b9-8973986ad589
Category Human OTC Drug Label
Packager MARKSANS PHARMA LIMITED
Generic Name
Product Class
Product Number
Application Number ANDA091239
  • 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


    Ibuprofen Tablets USP, 200mg


    500 counts
    Bottle Label



    ibu-tab-500-bott-label



    Ibuprofen Tablets USP, 200mg


    1000 counts
    Bottle Label



    ibu-tab-1000-bott-label


    Ibuprofen Tablets USP, 200mg (Caplets)


    300 counts
    Bottle Label



    ibu-cap-300-bott-label





  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-114
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorBROWNScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 114
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-114-0330 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2011
    2NDC:25000-114-141000 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2011
    3NDC:25000-114-204 in 1 BOX07/25/2011
    36500 in 1 BAG; Type 0: Not a Combination Product
    4NDC:25000-114-306 in 1 BOX07/25/2011
    46500 in 1 BAG; Type 0: Not a Combination Product
    5NDC:25000-114-981 in 1 BOX07/25/2011
    534065 in 1 BAG; Type 0: Not a Combination Product
    6NDC:25000-114-931 in 1 BOX07/25/2011
    637470 in 1 BAG; Type 0: Not a Combination Product
    7NDC:25000-114-70500 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2011
    8NDC:25000-114-711000 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09123907/25/2011
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-117
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorBROWNScoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code 117
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-117-0330 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2011
    2NDC:25000-117-141000 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2011
    3NDC:25000-117-204 in 1 BOX07/25/2011
    36500 in 1 BAG; Type 0: Not a Combination Product
    4NDC:25000-117-306 in 1 BOX07/25/2011
    46500 in 1 BAG; Type 0: Not a Combination Product
    5NDC:25000-117-981 in 1 BOX07/25/2011
    534065 in 1 BAG; Type 0: Not a Combination Product
    6NDC:25000-117-931 in 1 BOX07/25/2011
    637470 in 1 BAG; Type 0: Not a Combination Product
    7NDC:25000-117-69300 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09123907/25/2011
    Labeler - MARKSANS PHARMA LIMITED (925822975)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975LABEL(25000-117) , MANUFACTURE(25000-114, 25000-117)

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