Label: IBUPROFEN- ibuprofen 600mg tablet, film coated

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

Drug Label Information

Updated March 10, 2021

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  • How Supplied Section

    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

  • Medication Guide Section

    IBUPROFEN- ibuprofen tablet, film coated
    TIME CAP LABORATORIES, INC

    ----------

    ibuprofen tablets 400 mg - 600 mg- 800 mg medguide

    [MEDGUIDE IBUPROFEN TABLETS]

    Revised: 12/2019
    TIME CAP LABORATORIES, INC

  • Principal Display Panel

    Ibuprofen 600mg

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen 600mg tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80425-0132(NDC:49483-603)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN600 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code 122
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80425-0132-390 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09079612/30/2015
    Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Rx Pharmacy of Tennseess, LLC117023142repack(80425-0132)