Label: IBUPROFEN tablet, film coated

  • NDC Code(s): 71335-1396-0, 71335-1396-1, 71335-1396-2, 71335-1396-3, view more
    71335-1396-4, 71335-1396-5, 71335-1396-6, 71335-1396-7, 71335-1396-8, 71335-1396-9, 71335-1503-0, 71335-1503-1, 71335-1503-2, 71335-1503-3, 71335-1503-4, 71335-1503-5, 71335-1503-6, 71335-1503-7, 71335-1503-8, 71335-1503-9, 71335-1517-1, 71335-1517-2, 71335-1517-3, 71335-1517-4, 71335-1517-5, 71335-1517-6, 71335-1517-7, 71335-1517-8, 71335-1517-9
  • Packager: Bryant Ranch Prepack
  • This is a repackaged label.
  • Source NDC Code(s): 49483-602, 49483-603, 49483-604
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 27, 2020

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  • ibuprofen tablets 400 mg - 600 mg- 800 mg medguide

    MEDGUIDE IBUPROFEN TABLETS

  • HOW SUPPLIED

    Product: 71335-1396

    NDC: 71335-1396-0 84 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1396-1 20 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1396-2 15 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1396-3 40 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1396-4 21 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1396-5 30 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1396-6 90 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1396-7 100 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1396-8 120 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1396-9 60 TABLET, FILM COATED in a BOTTLE

    Product: 71335-1503

    NDC: 71335-1503-0 21 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1503-1 20 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1503-2 15 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1503-3 30 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1503-4 40 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1503-5 60 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1503-6 90 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1503-7 120 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1503-8 50 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1503-9 100 TABLET, FILM COATED in a BOTTLE

    Product: 71335-1517

    NDC: 71335-1517-1 20 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1517-2 30 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1517-3 40 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1517-4 60 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1517-5 90 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1517-6 120 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1517-7 100 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1517-8 21 TABLET, FILM COATED in a BOTTLE

    NDC: 71335-1517-9 15 TABLET, FILM COATED in a BOTTLE

  • Ibuprofen 800mg Tablet

    Label Image
  • Ibuprofen 600mg Tablet

    Label Image
  • Ibuprofen 400mg Tablet

    Label Image
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71335-1396(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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code 123
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-1396-084 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2019
    2NDC:71335-1396-120 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2019
    3NDC:71335-1396-215 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2019
    4NDC:71335-1396-340 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2019
    5NDC:71335-1396-421 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2019
    6NDC:71335-1396-530 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2019
    7NDC:71335-1396-690 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2019
    8NDC:71335-1396-7100 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2019
    9NDC:71335-1396-8120 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2019
    10NDC:71335-1396-960 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09079612/30/2015
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71335-1503(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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code 122
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-1503-021 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
    2NDC:71335-1503-120 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
    3NDC:71335-1503-215 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
    4NDC:71335-1503-330 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
    5NDC:71335-1503-440 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
    6NDC:71335-1503-560 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
    7NDC:71335-1503-690 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
    8NDC:71335-1503-7120 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
    9NDC:71335-1503-850 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
    10NDC:71335-1503-9100 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09079612/30/2015
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71335-1517(NDC:49483-602)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize13mm
    FlavorImprint Code 121
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-1517-120 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2020
    2NDC:71335-1517-230 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2020
    3NDC:71335-1517-340 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2020
    4NDC:71335-1517-460 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2020
    5NDC:71335-1517-590 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2020
    6NDC:71335-1517-6120 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2020
    7NDC:71335-1517-7100 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2020
    8NDC:71335-1517-821 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2020
    9NDC:71335-1517-915 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09079612/30/2015
    Labeler - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-1517, 71335-1396, 71335-1503) , RELABEL(71335-1396, 71335-1503, 71335-1517)
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