ASPIRIN ENTERIC COATED- aspirin tablet, coated
Unit Dose Services

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ASPIRIN ENTERIC COATED

HOW SUPPLIED

Product: 50436-0127

ASPIR LOW (ASPIRIN) TABLET

ASPIRIN ENTERIC COATED
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50436-0127(NDC:49483-481)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	HEART
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50436-0127-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2015	12/31/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	06/19/2015	12/31/2017

Labeler - Unit Dose Services (831995316)

Name	Address	ID/FEI	Business Operations
Establishment
Unit Dose Services		831995316	REPACK(50436-0127) , RELABEL(50436-0127)

Revised: 1/2019

Document Id: 8a12f07d-f089-48f9-8a3d-e597a452ebd4

Set id: 8ebcbc13-0323-454a-9834-b6ea326d4e46

Version: 9

Effective Time: 20190117

Unit Dose Services