Label: IBUPROFEN tablet, film coated

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

Drug Label Information

Updated December 23, 2020

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

    MEDGUIDE IBUPROFEN TABLETS

  • HOW SUPPLIED

    Product: 53002-3011

    NDC: 53002-3011-1 10 TABLET, FILM COATED in a BOTTLE

    NDC: 53002-3011-2 15 TABLET, FILM COATED in a BOTTLE

    NDC: 53002-3011-4 30 TABLET, FILM COATED in a BOTTLE

    NDC: 53002-3011-5 50 TABLET, FILM COATED in a BOTTLE

  • Ibuprofen 600mg Tablets, USP

    Label Image
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53002-3011(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:53002-3011-430 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
    2NDC:53002-3011-110 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
    3NDC:53002-3011-550 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
    4NDC:53002-3011-215 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09079612/30/2015
    Labeler - RPK Pharmaceuticals, Inc. (147096275)
    Establishment
    NameAddressID/FEIBusiness Operations
    RPK Pharmaceuticals, Inc.147096275RELABEL(53002-3011) , REPACK(53002-3011)