Label: IBUPROFEN tablet, film coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 5, 2023

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  • MEDICATION GUIDE

    [MEDGUIDE IBUPROFEN TABLETS]

  • HOW SUPPLIED

    400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side) Bottles of 100 & 500

  • HOW SUPPLIED

    600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain on the other side) Bottles of 30, 50, 100 & 500

  • HOW SUPPLIED

    800 mg (white to off-white, capsule shaped, biconvex, film-coated​ tablets debossed with ‘123’ on one side and plain on other side)

  • PRINCIPAL DISPLAY PANEL

    231

  • PRINCIPAL DISPLAY PANEL

    266

  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

    67836482764

  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

    72189-231-90

  • PRINCIPAL DISPLAY PANEL

    72189-231-60

  • PRINCIPAL DISPLAY PANEL

    72189-231-30

  • PRINCIPAL DISPLAY PANEL

    72189-266-15

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72189-266(NDC:49483-604)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN800 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code 123
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72189-266-4040 in 1 BOTTLE; Type 0: Not a Combination Product09/16/2021
    2NDC:72189-266-9090 in 1 BOTTLE; Type 0: Not a Combination Product09/16/2021
    3NDC:72189-266-3030 in 1 BOTTLE; Type 0: Not a Combination Product09/16/2021
    4NDC:72189-266-71100 in 1 BOTTLE; Type 0: Not a Combination Product09/16/2021
    5NDC:72189-266-72120 in 1 BOTTLE; Type 0: Not a Combination Product09/16/2021
    6NDC:72189-266-6060 in 1 BOTTLE; Type 0: Not a Combination Product09/16/2021
    7NDC:72189-266-1515 in 1 BOTTLE; Type 0: Not a Combination Product09/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09079609/16/2021
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72189-231(NDC:49483-603)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN600 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code 122
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72189-231-2121 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2021
    2NDC:72189-231-6060 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2021
    3NDC:72189-231-9090 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2021
    4NDC:72189-231-3030 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09079606/04/2021
    Labeler - DIRECT RX (079254320)
    Registrant - DIRECT RX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIRECT RX079254320repack(72189-231, 72189-266)
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