ALKA-SELTZER COOL ACTION HEARTBURN RELIEF MINT- calcium carbonate gum, chewing

Alka-Seltzer Cool Action Heartburn Relief by

Drug Labeling and Warnings

Alka-Seltzer Cool Action Heartburn Relief 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 chewing piece)

Calcium carbonate 750 mg

PURPOSE

Purpose

Antacid

Uses

Uses for the relief of:

● acid indigestion ● heartburn ● sour stomach

● upset stomach associated with these symptoms

WARNINGS

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 use more than 5 pieces in a 24-hour period

● if pregnant do not use more than 5 pieces 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

If pregnant or breast-feeding, inform your doctor that you are using this product.

Keep out of reach of children.

Directions

Directions

● adults and children 12 years and over: chew 1 - 2 pieces as symptoms occur or as directed by a doctor

● children under 12 years: consult a doctor

● do not use more than 5 pieces in a 24-hour period

● if pregnant, do not use more than 5 pieces in 24-hour period

● do not swallow the gum

OTHER SAFETY INFORMATION

Other information

● each piece contains: calcium 300 mg

● store at room temperature. Avoid humidity and excessive heat above 40ºC (104ºF).

INACTIVE INGREDIENT

Inactive ingredients acesulfame potassium, butylated hydroxytoluene, copovidone, FD&C Blue No.1 Aluminum Lake, flavors, gum base, isomalt, magnesium stearate, sorbitol, sucralose, talc, titanium dioxide

QUESTIONS

Questions or comments? 1-800-986-0369

(Mon – Fri 9AM – 5PM EST)

Carton count 16 pieces

Works Fast!

Alka-Seltzer®

Calcium Carbonate/

Antacid

EXTRA STRENGTH

COOL ACTION

HEARTBURN RELIEF

GUM

cool mint

16 pieces

INGREDIENTS AND APPEARANCE

ALKA-SELTZER COOL ACTION HEARTBURN RELIEF  MINT
calcium carbonate gum, chewing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-0001
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
ISOMALT (UNII: S870P55O2W)
SORBITOL (UNII: 506T60A25R)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Product Characteristics
Color	blue (Blue and white; Active on white)	Score	no score
Shape	ROUND	Size	16mm
Flavor	MINT	Imprint Code	750
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-0001-01	2 in 1 CARTON	03/01/2020
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0280-0001-02	1 in 1 CARTON	05/01/2020
2		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	03/01/2020

Labeler - Bayer HealthCare LLC. (112117283)