NDC Code(s) : 59779-738-63, 59779-738-71, 59779-738-33
Packager : CVS Pharmacy

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acid Reducer Plus Antacidfamotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-738
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)
(HYDROXIDE ION - UNII:9159UV381P) 		MAGNESIUM HYDROXIDE165 mg
CALCIUM CARBONATE(UNII: H0G9379FGK)
(CALCIUM CATION - UNII:2M83C4R6ZB) 		CALCIUM CARBONATE800 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
ASPARTAME(UNII: Z0H242BBR1)
D&C RED NO. 7(UNII: ECW0LZ41X8)
DEXTRATES(UNII: G263MI44RU)
FD&C BLUE NO. 1 ALUMINUM LAKE(UNII: J9EQA3S2JM)
FD&C RED NO. 40 ALUMINUM LAKE(UNII: 6T47AS764T)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
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:59779-738-6325 in 1 BOTTLE Type 0: Not a Combination Product02/11/2016
2NDC:59779-738-7150 in 1 BOTTLE Type 0: Not a Combination Product02/11/2016
3NDC:59779-738-3360 in 1 BOTTLE Type 0: Not a Combination Product06/08/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077355 02/11/2016

LABELER - CVS Pharmacy(062312574)

PRINCIPAL DISPLAY PANEL

CVS Health®

Compare to the active ingredients in Pepcid Complete®

Dual-Action Complete

Acid Reducer Plus Antacid

FAMOTIDINE 10mg/CALCIUM CARBONATE 800 mg/MAGNESIUM HYDROXIDE 165 mg TABLETS (CHEWABLE)

Acid reducer plus antacid

Just One Tablet:

Relieves heartburn due to acid indigestion

Berry Flavor

Actual Size

50 CHEWABLE TABLETS

cvshealth-acid-reducer-plus-antacid-berry-container-image.jpg