NDC Code(s) : 16103-351-09, 16103-351-16, 16103-351-11
Packager : Pharbest Pharmaceuticals, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Adult Low Dose Aspirin Enteric CoatedAspirin 81mg TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:16103-351
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN(UNII: R16CO5Y76E)
(ASPIRIN - UNII:R16CO5Y76E) 		ASPIRIN81 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2)(UNII: XRK36F13ZZ)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color yellow (YELLOW COLOR) Score no score
Shape ROUND (ROUND TABLET) Size 7 mm
Flavor Imprint Code EA8
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16103-351-09120 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/02/2019
2NDC:16103-351-16300 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/02/2019
3NDC:16103-351-111000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/02/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M013 02/20/2019

LABELER - Pharbest Pharmaceuticals, Inc.(557054835)

REGISTRANT - Pharbest Pharmaceuticals, Inc.(557054835)

Establishment
Name Address ID/FEI Business Operations
Pharbest Pharmaceuticals, Inc. 557054835 manufacture(16103-351), pack(16103-351), analysis(16103-351), label(16103-351)

PRINCIPAL DISPLAY PANEL

PHARBEST

NDC 16103-351-16

Manufactured in the USA

*Compare to the active ingredient in Bayer® Low Dose

Adult Low Dose

Aspirin

ENTERIC COATED

81mg

Aspirin 81 mg

Pain Reliever (NSAID)

EA8

1000 TABLETS

Talk to you doctor or other healthcare provider before using this product for your heart.

Adult low Dose Aspirin 81 mg Enteric Coated (EA8) tablet Product Label