NDC Code(s) : 0280-0245-50
Packager : Bayer HealthCare LLC.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Alka-Seltzer Ultra Strength Heartburn ReliefChewsCalcium carbonate TABLET, CHEWABLE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0245
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
(CALCIUM CATION - UNII:2M83C4R6ZB) 		CALCIUM CARBONATE1000 mg
Inactive Ingredients
Ingredient Name Strength
SHELLAC(UNII: 46N107B71O)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TURMERIC(UNII: 856YO1Z64F)
ANNATTO(UNII: 6PQP1V1B6O)
.ALPHA.-TOCOPHEROL, DL-(UNII: 7QWA1RIO01)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
SODIUM ASCORBATE(UNII: S033EH8359)
WATER(UNII: 059QF0KO0R)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
SUNFLOWER OIL(UNII: 3W1JG795YI)
STARCH, POTATO(UNII: 8I089SAH3T)
COCONUT OIL(UNII: Q9L0O73W7L)
CORN OIL(UNII: 8470G57WFM)
PALM OIL(UNII: 5QUO05548Z)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SORBIC ACID(UNII: X045WJ989B)
SORBITOL(UNII: 506T60A25R)
ACACIA(UNII: 5C5403N26O)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
EDETATE DISODIUM(UNII: 7FLD91C86K)
HYDROGENATED COCONUT OIL(UNII: JY81OXM1OM)
WHITE WAX(UNII: 7G1J5DA97F)
CARNAUBA WAX(UNII: R12CBM0EIZ)
.BETA.-CAROTENE(UNII: 01YAE03M7J)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
CORN SYRUP(UNII: 9G5L16BK6N)
METHYLPARABEN(UNII: A2I8C7HI9T)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SUCROSE(UNII: C151H8M554)
Product Characteristics
Color yellow, orange Score no score
Shape ROUND Size 18 mm
Flavor MANGO, PEACH, TROPICAL FRUIT PUNCH Imprint Code U2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0280-0245-5050 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product03/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M001 03/01/2017

LABELER - Bayer HealthCare LLC.(112117283)

PRINCIPAL DISPLAY PANEL

tropical twist

Alka-Seltzer®

Calcium Carbonate/Antacid

ULTRA STRENGTH

HEARTBURN

RELIEFCHEWS®

FAST POWERFUL RELIEF

50 CHEWABLE TABLETS

Label 50 count