ALKA-SELTZER FRUIT CHEWS- calcium carbonate tablet, chewable
Bayer HealthCare LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Alka-Seltzer ® Fruit Chews

Drug Facts

Active ingredient (in each chewable tablet)

Calcium carbonate 750 mg

Purpose

Antacid

Uses

for the relief of:

acid indigestion
heartburn
sour stomach
upset stomach associated with these symptoms

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

do not take more than 10 chewable tablets in a 24-hour period
do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician
constipation may occur

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Directions

adults and children 12 years and over: chew and swallow 1-2 chewable tablets every 2 to 4 hours as symptoms occur, or as directed by a doctor
children under 12 years: consult a doctor
do not take more than 10 chewable tablets in a 24-hour period

Other information

each chewable tablet contains: calcium 300 mg
contains FD&C Yellow No. 5 (tartrazine) as a color additive
store at room temperature. Avoid humidity. Close cap tightly after use.

Inactive ingredients

acacia, beeswax, carmine, carnauba wax, citric acid, corn starch, corn syrup, DL-alpha tocopherol, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #5 lake (tartrazine), FD&C yellow #6, FD&C yellow #6 aluminum lake, FD&C yellow #6 lake, flavors, hydrogenated coconut oil, medium chain triglycerides, methyl paraben, modified starch, phosphoric acid, pregelatinized modified starch, propyl paraben, propylene glycol, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide

Questions or comments?

1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.alkaseltzer.com

Distributed by:
Bayer HealthCare LLC
P.O. Box 1910
Morristown, NJ 07962-1910 USA

PRINCIPAL DISPLAY PANEL - 36 Tablet Bottle Label

NEW!

Orange
Lemon
Strawberry

Alka-
Seltzer ®
Calcium Carbonate /
Antacid

FRUIT CHEWS

FOR FAST RELIEF OF

HEARTBURN
ACID INDIGESTION
UPSET STOMACH

36 CHEWABLE TABLETS

Principal Display Panel - 36 Tablet Bottle Label

ALKA-SELTZER FRUIT CHEWS
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0280-4095
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	750 mg

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
YELLOW WAX (UNII: 2ZA36H0S2V)
PIGMENT RED 5 (UNII: 91OZU993LX)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
STARCH, CORN (UNII: O8232NY3SJ)
CORN SYRUP (UNII: 9G5L16BK6N)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ALUMINUM OXIDE (UNII: LMI26O6933)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHOSPHORIC ACID (UNII: E4GA8884NN)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SHELLAC (UNII: 46N107B71O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBIC ACID (UNII: X045WJ989B)
SORBITOL (UNII: 506T60A25R)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SUCROSE (UNII: C151H8M554)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange, yellow, pink	Score	no score
Shape	OVAL	Size	18mm
Flavor	ORANGE, LEMON, STRAWBERRY	Imprint Code	AS
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0280-4095-36	36 in 1 BOTTLE; Type 0: Not a Combination Product	03/15/2013	06/01/2015
2	NDC:0280-4095-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/15/2013	06/01/2015
3	NDC:0280-4095-01	1 in 1 POUCH; Type 0: Not a Combination Product	03/15/2013	06/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	03/15/2013	06/01/2015

Labeler - Bayer HealthCare LLC. (112117283)

Revised: 12/2017

Document Id: 60a01a76-047a-75e3-e053-2a91aa0ad385

Set id: e09648f2-4b46-4461-8554-9c4866650f90

Version: 2

Effective Time: 20171218

Bayer HealthCare LLC.