ALKA-SELTZER HEARTBURN PLUS GAS RELIEFCHEWS TROPICAL PUNCH- calcium carbonate and simethicone tablet, chewable

Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical Punch by

Drug Labeling and Warnings

Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical Punch by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each chewable tablet)	Purpose
Calcium carbonate 750 mg	Antacid
Simethicone 80 mg	Antigas

Uses

for the relief of:

• acid indigestion
• heartburn
• sour stomach
• upset stomach associated with these symptoms
• bloating, pressure, or stuffed feeling commonly referred to as gas

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 6 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 6 chewable tablets in a 24-hour period

Other information

• each chewable tablet contains: calcium 330 mg
• store at room temperature. Avoid excessive heat above 40°C (104°F).
• close cap tightly after use

Inactive ingredients

acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, FD&C red #40 aluminum lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, maltodextrin, methyl paraben, modified starch, potassium hydroxide, pregelatinized modified starch, propyl paraben, propylene glycol, shellac, sorbic acid, sorbitol, sugar, titanium dioxide, triacetin, water, white wax

Questions?

1-800-986-0369

SPL UNCLASSIFIED SECTION

Dist. by:
Bayer HealthCare LLC
Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 32 Tablet Bottle Label

Alka-

Seltzer ®

Calcium Carbonate / Antacid

Simethicone / AntiGas

tropical punch

HEARTBURN+GAS

RELIEFCHEW™

Fast Powerful Relief

BAYER

32 CHEWABLE TABLETS

INGREDIENTS AND APPEARANCE

ALKA-SELTZER HEARTBURN PLUS GAS RELIEFCHEWS TROPICAL PUNCH 
calcium carbonate and simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-0225
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	80 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	750 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	18mm
Flavor	TROPICAL FRUIT PUNCH	Imprint Code	HG
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-0225-32	32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/15/2014
2	NDC: 0280-0225-54	54 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/15/2014
3	NDC: 0280-0225-82	82 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	03/15/2014

Labeler - Bayer HealthCare LLC. (112117283)