NDC Code(s) : 37808-546-63
Packager : H E B

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

completeFamotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:37808-546
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE(UNII: 5QZO15J2Z8)
(FAMOTIDINE - UNII:5QZO15J2Z8) 		FAMOTIDINE10 mg
CALCIUM CARBONATE(UNII: H0G9379FGK)
(CARBONATE ION - UNII:7UJQ5OPE7D) 		CALCIUM CARBONATE800 mg
MAGNESIUM HYDROXIDE(UNII: NBZ3QY004S)
(MAGNESIUM HYDROXIDE - UNII:NBZ3QY004S) 		MAGNESIUM HYDROXIDE165 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
ASPARTAME(UNII: Z0H242BBR1)
DEXTRATES(UNII: G263MI44RU)
FERRIC OXIDE RED(UNII: 1K09F3G675)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE(UNII: FZ989GH94E)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color ORANGE (PEACH WITH WHITE SPECKLES) Score no score
Shape ROUND Size 18 mm
Flavor MINT Imprint Code L546
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37808-546-6325 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077355 09/14/2008

PRINCIPAL DISPLAY PANEL

Compare to Pepcid Complete® active ingredients

Dual Action

COMPLETE

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

Acid Reducer Plus Antacid

ACTUAL SIZE

Just One Tablet Relieves Heartburn Due to Acid Indigestion

Cool Mint Flavor

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