Label: IBUPROFEN tablet, film coated

  • NDC Code(s): 49483-602-01, 49483-602-50, 49483-603-01, 49483-603-03, view more
    49483-603-05, 49483-603-50, 49483-604-01, 49483-604-03, 49483-604-05, 49483-604-50
  • Packager: TIME CAP LABORATORIES, INC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 30, 2019

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

    MEDGUIDE IBUPROFEN TABLETS

  • HOW SUPPLIED

    400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side) Bottles of 100 & 500

  • 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

  • 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)

  • 400mg Ibuprofen 100 count label

    400 mg label

  • 400 mg 500 count label

    400 mg 500 count label

  • 600 mg 100 count label

    600 mg 100 count label

  • 800 mg 100 count label

    800 mg 100 count label

  • 600 MG 500 COUNT LABEL

    600 MG 500 CT LABEL

  • 800 MG 500 COUNT LABEL

    800 MG 500 COUNT LABEL

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)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)  
    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
    ShapeROUNDSize13mm
    FlavorImprint Code 121
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-602-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2015
    2NDC:49483-602-50500 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
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)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)  
    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
    ShapeCAPSULESize18mm
    FlavorImprint Code 122
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-603-0330 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2015
    2NDC:49483-603-0550 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2015
    3NDC:49483-603-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2015
    4NDC:49483-603-50500 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
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)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:49483-604-0330 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2015
    2NDC:49483-604-0550 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2015
    3NDC:49483-604-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2015
    4NDC:49483-604-50500 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 - TIME CAP LABORATORIES, INC (037052099)
    Registrant - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(49483-602, 49483-603, 49483-604)
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