NDC Code(s) : 52389-117-01, 52389-117-28
Packager : Alva-Amco Pharmacal Companies, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Pep-Back Caffeine TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52389-117
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Caffeine(UNII: 3G6A5W338E)
(Caffeine - UNII:3G6A5W338E) 		Caffeine200 mg
Inactive Ingredients
Ingredient Name Strength
Acacia(UNII: 5C5403N26O)
Calcium carbonate(UNII: H0G9379FGK)
FD&C Red No. 40(UNII: WZB9127XOA)
FD&C Yellow No. 6(UNII: H77VEI93A8)
Hypromellose(UNII: 3NXW29V3WO)
Magnesium silicate(UNII: 9B9691B2N9)
Magnesium stearate(UNII: 70097M6I30)
Maltodextrin(UNII: 7CVR7L4A2D)
Cellulose, microcrystalline(UNII: OP1R32D61U)
Mineral oil(UNII: T5L8T28FGP)
Starch, corn(UNII: O8232NY3SJ)
Stearic acid(UNII: 4ELV7Z65AP)
Taurine(UNII: 1EQV5MLY3D)
Titanium dioxide(UNII: 15FIX9V2JP)
Triacetin(UNII: XHX3C3X673)
Product Characteristics
Color red Score no score
Shape OVAL Size 15 mm
Flavor Imprint Code ALVA;1reverse
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52389-117-282 in 1 CARTON
1NDC:52389-117-0114 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part340 03/28/2007

PRINCIPAL DISPLAY PANEL

PepBack Peak Performance PDP