LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [BRYANT RANCH PREPACK]

LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [BRYANT RANCH PREPACK]
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NDC	71335-0932-1, 71335-0932-2, 71335-0932-3
Set ID	350a95d3-de67-43c8-ab3e-d53b63be30e8
Category	HUMAN OTC DRUG LABEL
Packager	Bryant Ranch Prepack
Generic Name
Product Class
Product Number
Application Number	PART343

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ACTIVE INGREDIENT
INACTIVE INGREDIENT
DOSAGE & ADMINISTRATION
INDICATIONS & USAGE
WARNINGS
PURPOSE
KEEP OUT OF REACH OF CHILDREN
HOW SUPPLIED

Product: 71335-0932

NDC: 71335-0932-1 90 TABLET, COATED in a BOTTLE

NDC: 71335-0932-2 800 TABLET, COATED in a BOTTLE

NDC: 71335-0932-3 30 TABLET, COATED in a BOTTLE
ASPIRIN 81MG TABLET

INGREDIENTS AND APPEARANCE

LOW DOSE ASPIRIN
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-0932(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:71335-0932-1	90 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2015
2	NDC:71335-0932-2	800 in 1 BOTTLE; Type 0: Not a Combination Product	09/12/2018
3	NDC:71335-0932-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/12/2018

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

Labeler - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-0932) , RELABEL(71335-0932)

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