ACIDO ACETILSALICILICO WITH ENTERIC COAT- aspirin tablet, coated

Acido Acetilsalicilico by

Drug Labeling and Warnings

Acido Acetilsalicilico by is a Otc medication manufactured, distributed, or labeled by 4Medical Group LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACIDO ACETILSALICILICO  WITH ENTERIC COAT
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83337-232(NDC:69168-405)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	HEART
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83337-232-24	40 in 1 BOX; Type 0: Not a Combination Product	07/03/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		07/03/2023

Labeler - 4Medical Group LLC (067443990)

Establishment
Name	Address	ID/FEI	Business Operations
4Medical Group LLC		067443990	relabel(83337-232)