NDC Code(s) : 0280-0225-32, 0280-0225-54, 0280-0225-82, 0280-0225-01, 0280-0225-02, 0280-0225-03
Packager : Bayer HealthCare LLC.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical PunchCALCIUM CARBONATE AND SIMETHICONE TABLET, CHEWABLE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0225
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE80 mg
CALCIUM CARBONATE(UNII: H0G9379FGK)
(CALCIUM CATION - UNII:2M83C4R6ZB) 		CALCIUM CARBONATE750 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA(UNII: 5C5403N26O)
CARNAUBA WAX(UNII: R12CBM0EIZ)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)(UNII: 461P5CJN6T)
CORN SYRUP(UNII: 9G5L16BK6N)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
FD&C RED NO. 40(UNII: WZB9127XOA)
HYDROGENATED COCONUT OIL(UNII: JY81OXM1OM)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SORBIC ACID(UNII: X045WJ989B)
SORBITOL(UNII: 506T60A25R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
WATER(UNII: 059QF0KO0R)
WHITE WAX(UNII: 7G1J5DA97F)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color pink Score no score
Shape ROUND Size 18 mm
Flavor TROPICAL FRUIT PUNCH Imprint Code HG
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0280-0225-3232 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/03/2014
2NDC:0280-0225-5454 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/03/2014
3NDC:0280-0225-8282 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product03/01/2017
4NDC:0280-0225-01110 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product03/01/2020
5NDC:0280-0225-0228 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/03/2014
6NDC:0280-0225-0360 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product03/01/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M001 03/15/2014

LABELER - Bayer HealthCare LLC.(112117283)

PRINCIPAL DISPLAY PANEL

Alka-

Seltzer ®

Calcium Carbonate / Antacid

Simethicone / AntiGas

tropical punch

HEARTBURN+GAS

RELIEFCHEW™

Fast Powerful Relief

BAYER

32 CHEWABLE TABLETS

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