NDC Code(s) : 0280-0042-08, 0280-0042-36, 0280-0042-60, 0280-0042-90
Packager : Bayer HealthCare LLC.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Alka-Seltzer Extra Strength Heartburn ReliefChewsCalcium carbonate TABLET, CHEWABLE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0042
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 CATION750 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA(UNII: 5C5403N26O)
SORBITOL(UNII: 506T60A25R)
RAW SUGAR(UNII: 8M707QY5GH)
WHITE WAX(UNII: 7G1J5DA97F)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
CARNAUBA WAX(UNII: R12CBM0EIZ)
.ALPHA.-TOCOPHEROL, DL-(UNII: 7QWA1RIO01)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
HYDROGENATED COCONUT OIL(UNII: JY81OXM1OM)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)(UNII: 461P5CJN6T)
CORN SYRUP(UNII: 9G5L16BK6N)
SHELLAC(UNII: 46N107B71O)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SORBIC ACID(UNII: X045WJ989B)
WATER(UNII: 059QF0KO0R)
CARMINIC ACID(UNII: CID8Z8N95N)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PHOSPHORIC ACID(UNII: E4GA8884NN)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
Product Characteristics
Color orange, yellow, pink Score no score
Shape ROUND Size 25 mm
Flavor LEMON, STRAWBERRY, ORANGE Imprint Code AS
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0280-0042-088 in 1 POUCH Type 0: Not a Combination Product15/09/2016
2NDC:0280-0042-3636 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/09/2016
3NDC:0280-0042-6060 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/09/2016
4NDC:0280-0042-9090 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/09/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M001 09/15/2016

LABELER - Bayer HealthCare LLC.(112117283)

PRINCIPAL DISPLAY PANEL

assorted fruit

Alka-Seltzer

Calcium Carbonate / Antacid

Extra Strength

Heartburn ReliefChews

Fast

Powerful

relief

Bayer

60 CHEWABLE TABLETS

ASESHBRC