NDC Code(s) : 52389-154-09, 52389-154-18, 52389-154-12, 52389-154-36
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:52389-154
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
CALCIUM CARBONATE(UNII: H0G9379FGK)
CALCIUM SULFATE DIHYDRATE(UNII: 4846Q921YM)
STARCH, CORN(UNII: O8232NY3SJ)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM SILICATE(UNII: 9B9691B2N9)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MINERAL OIL(UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL 600(UNII: NL4J9F21N9)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
STEARIC ACID(UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ETHYL VANILLIN(UNII: YC9ST449YJ)
Product Characteristics
Color green Score no score
Shape OVAL Size 15 mm
Flavor Imprint Code ALVA
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52389-154-182 in 1 CARTON 03/01/2011
1NDC:52389-154-099 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:52389-154-363 in 1 CARTON 15/09/2008
2NDC:52389-154-1212 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part340 04/08/1993

PRINCIPAL DISPLAY PANEL

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