NDC Code(s) : 16103-356-09, 16103-356-11
Packager : Pharbest Pharmaceuticals, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Adult Low Dose AspirinAspirin TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:16103-356
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)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2)(UNII: XRK36F13ZZ)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
STARCH, CORN(UNII: O8232NY3SJ)
STEARIC ACID(UNII: 4ELV7Z65AP)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color yellow (YELLOW COLOR) Score no score
Shape ROUND (ROUND TABLET) Size 8 mm
Flavor Imprint Code PH023
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16103-356-091 in 1 CARTON 01/12/2007
1120 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
2NDC:16103-356-111000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/12/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M 01/12/2007

LABELER - Pharbest Pharmaceuticals, Inc.(557054835)

REGISTRANT - Pharbest Pharmaceuticals, Inc.(557054835)

Establishment
Name Address ID/FEI Business Operations
Pharbest Pharmaceuticals, Inc. 557054835 analysis(16103-356), manufacture(16103-356), pack(16103-356), label(16103-356)

PRINCIPAL DISPLAY PANEL

PHARBEST

NDC 16103-356-09

Manufactured in the U.S.A

Low Dose

Aspirin

Pain Reliever (NSAID)

† COMPARE to the active ingredient in BAYER ® LOW DOSE

Aspirin Regimen 81 mg each

120 ENTERIC COATED TABLETS

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

Aspirin 81mg Enteric coated Tablet Product Label.jpg