Label: ACIDO ACETILSALICILICO WITH ENTERIC COAT- aspirin tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated July 6, 2023

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  • PRINCIPAL DISPLAY PANEL

    Aspiring 81mg NDC 83337-232

  • INGREDIENTS AND APPEARANCE
    ACIDO ACETILSALICILICO  WITH ENTERIC COAT
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83337-232(NDC:69168-405)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM HYDRIDE (UNII: 23J3BHR95O)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code HEART
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83337-232-2440 in 1 BOX; Type 0: Not a Combination Product07/03/2023
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only07/03/2023
    Labeler - 4Medical Group LLC (067443990)
    Establishment
    NameAddressID/FEIBusiness Operations
    4Medical Group LLC067443990relabel(83337-232)
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