Label: IBUPROFEN tablet, film coated

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

Drug Label Information

Updated January 2, 2020

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

    MEDGUIDE IBUPROFEN TABLETS

  • 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)

    NDC

    60760-603-20 BOTTLES OF 20

    60760-603-28 BOTTLES OF 28

    60760-603-40 BOTTLES OF 40

    60760-603-60 BOTTLES OF 60

  • PRINCIPAL DISPLAY PANEL

    ibu

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60760-603(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
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code 122
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60760-603-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/21/2019
    2NDC:60760-603-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/21/2019
    3NDC:60760-603-2828 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/10/2019
    4NDC:60760-603-4040 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09079610/21/2019
    Labeler - St. Mary's Medical Park Pharmacy (063050751)
    Establishment
    NameAddressID/FEIBusiness Operations
    St. Mary's Medical Park Pharmacy063050751relabel(60760-603) , repack(60760-603)