Label: ACETAMINOPHEN AND IBUPROFEN tablet

  • NDC Code(s): 62207-588-32, 62207-588-85
  • Packager: Granules India Limited
  • Category: BULK INGREDIENT
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated July 10, 2024

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  • PRINCIPAL DISPLAY PANEL

    62207-588-32

    62207-588-85

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN AND IBUPROFEN 
    acetaminophen and ibuprofen tablet
    Product Information
    Product TypeBULK INGREDIENTItem Code (Source)NDC:62207-588
    Route of AdministrationNOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN125 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Coloryellow (Light yellow to yellow colored) Scoreno score
    ShapeCAPSULE (capsule shaped, biconvex) Size14mm
    FlavorImprint Code G;131
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-588-3210000 in 1 DRUM08/30/2023
    2NDC:62207-588-8590000 in 1 DRUM03/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only08/30/2023
    Labeler - Granules India Limited (915000087)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Limited918609236analysis(62207-588) , manufacture(62207-588)