ACIDO ACETILSALICILICO WITH ENTERIC COAT- aspirin tablet, coated 
4Medical Group LLC

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OTC Label - Aspirin - Allegiant Health

Aspiring 81mg NDC 83337-232

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)

Revised: 7/2023
Document Id: ffdb39ca-51a5-2267-e053-6394a90adf3f
Set id: f783afa1-e1aa-c686-e053-6294a90a3354
Version: 3
Effective Time: 20230706
 
4Medical Group LLC