LOW DOSE ASPIRIN- aspirin tablet, coated
NuCare Pharmaceuticals,Inc.

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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LOW DOSE ASPIRIN
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68071-4449(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
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
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)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68071-4449-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2018
2	NDC:68071-4449-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2018
3	NDC:68071-4449-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2018

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

Labeler - NuCare Pharmaceuticals,Inc. (010632300)

Name	Address	ID/FEI	Business Operations
Establishment
NuCare Pharmaceuticals,Inc.		010632300	repack(68071-4449)