Label: IBUPROFEN tablet, film coated

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

Drug Label Information

Updated December 13, 2024

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

    MEDGUIDE IBUPROFEN TABLETS

  • 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)

    Supplied as:

    NDC 60760-604-09 BOTTLES OF 9

    NDC 60760-604-20 BOTTLES OF 20

    NDC 60760-604-30 BOTTLES OF 30

    NDC 60760-604-60 BOTTLES OF 60

    NDC 60760-604-90 BOTTLES OF 90

  • PRINCIPAL DISPLAY PANEL

    ibu

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60760-604(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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    STARCH, PREGELATINIZED 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:60760-604-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/16/2019
    2NDC:60760-604-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/16/2019
    3NDC:60760-604-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/16/2019
    4NDC:60760-604-00100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/202003/31/2022
    5NDC:60760-604-099 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/10/2020
    6NDC:60760-604-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09079610/16/2019
    Labeler - St. Mary's Medical Park Pharmacy (063050751)
    Establishment
    NameAddressID/FEIBusiness Operations
    St. Mary's Medical Park Pharmacy063050751relabel(60760-604) , repack(60760-604)
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