NDC Code(s) : 30142-321-63, 30142-321-71
Packager : Kroger Company

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dual Action Completefamotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:30142-321
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE(UNII: 5QZO15J2Z8)
(FAMOTIDINE - UNII:5QZO15J2Z8) 		FAMOTIDINE10 mg
MAGNESIUM HYDROXIDE(UNII: NBZ3QY004S)
(MAGNESIUM CATION - UNII:T6V3LHY838) 		MAGNESIUM HYDROXIDE165 mg
CALCIUM CARBONATE(UNII: H0G9379FGK)
(CALCIUM CATION - UNII:2M83C4R6ZB) 		CALCIUM CARBONATE800 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
DEXTRATES(UNII: G263MI44RU)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONES(UNII: FZ989GH94E)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color PINK (mottled) Score no score
Shape ROUND (bi-layered) Size 17 mm
Flavor BERRY Imprint Code L321
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:30142-321-6325 in 1 BOTTLE
2NDC:30142-321-7150 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077355 09/09/2008

PRINCIPAL DISPLAY PANEL

COMPARE TO the active ingredients of PEPCID COMPLETE®

See back panel

DUAL ACTION

Complete

Famotidine 10 mg/Calcium Carbonate 800 mg/Magnesium Hydroxide 165 mg Tablets

ACID REDUCER + ANTACID

Just One Tablet!

Relieves Heartburn Due to Acid Indigestion

Berry Flavor

25 CHEWABLE TABLETS

actual size

Complete Image 1Complete Image 1Complete Image 1