Label: IBUPROFEN tablet

  • NDC Code(s): 25000-114-02, 25000-114-03, 25000-114-14, 25000-114-20, view more
    25000-114-30, 25000-114-70, 25000-114-71, 25000-114-93, 25000-114-98, 25000-117-02, 25000-117-03, 25000-117-14, 25000-117-20, 25000-117-30, 25000-117-69, 25000-117-93, 25000-117-98
  • Packager: MARKSANS PHARMA LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 21, 2021

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  • 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 :

    • headache
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold
    • menstrual cramps

    temporarily reduces fever

  • Warnings

    Allergy alert: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.
    Symptoms may include: 

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock
    • skin reddening
    • rash
    • blisters

    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 had 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
    • take more or for a longer time than directed

    Heart attack and stroke warning: NSAID's except aspirin increase 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 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, 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 problems 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 the painful area
    any new symptoms appear


  • If pregnant or breast-feeding


    ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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 0F).
    • do not use if carton is opened. do not use if seal under bottle cap imprinted with” SEALED for YOUR PROTECTION” is broken or missing.
    • see end panel for lot number and expiration date
  • Inactive ingredients

    colloidal 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

    NDC 25000-114-03, Ibuprofen Tablets USP, 200mg


    30 counts Bottle Label



    ibu-tab-30ct-bottle-label




    NDC 25000-114-03, Ibuprofen Tablets USP, 200mg


    30 counts Carton Label


    ibu-tab-30ct-cart-label




    NDC 25000-117-03, Ibuprofen Tablets USP, 200mg (Caplets)


    30 counts Bottle Label



    ibu-cap-30ct-bottle-label


    NDC 25000-117-03, Ibuprofen Tablets USP, 200mg (Caplets)


    30 counts Carton Label


    ibu-cap-30ct-cart-label


    NDC 25000-114-70, Ibuprofen Tablets USP, 200mg


    500 counts Bottle Label



    ibu-tab-500ct-bottle-label


    NDC 25000-114-14, Ibuprofen Tablets USP, 200mg


    1000 counts Bottle Label



    ibu-tab-1000ct-bottle-label


    NDC 25000-114-71, Ibuprofen Tablets USP, 200mg


    1000 counts (PET)  Bottle Label


    ibu-tab-1000ct-pet-bottle-label


    NDC 25000-117-14, Ibuprofen Tablets USP, 200mg


    1000 counts Bottle Label (Caplets)


    ibu-cap-1000ct-bottle-label


    NDC 25000-117-69, Ibuprofen Tablets USP, 200mg (Caplets)


    300 counts Bottle Label


    ibu-tab-300ct-bottle-label


    NDC 25000-114-02, Ibuprofen Tablets USP, 200mg


    24 counts Bottle Label


    ibu-tab-24ct-bottle-label


    NDC 25000-114-02, Ibuprofen Tablets USP, 200mg


    24 counts Carton Label


    ibu-tab-24ct-cart-label


    NDC 25000-117-02, Ibuprofen Tablets USP, 200mg (Caplets)


    24 counts Bottle Label


    ibu-cap-24ct-bottle-label


    NDC 25000-117-02, Ibuprofen Tablets USP, 200mg (Caplets)


    24 counts Carton Label



    ibu-cap-24ct-cart-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
    9NDC:25000-114-021 in 1 CARTON12/20/2019
    924 in 1 BOTTLE; Type 0: Not a Combination Product
    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
    8NDC:25000-117-021 in 1 CARTON12/20/2019
    824 in 1 BOTTLE; Type 0: Not a Combination Product
    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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