ALKA-SELTZER COOL ACTION EXTRA STRENGTH RELIEFCHEWS MINT- calcium carbonate tablet, chewable

Alka-Seltzer Cool Action Extra Strength ReliefChews Mint by

Drug Labeling and Warnings

Alka-Seltzer Cool Action Extra Strength ReliefChews Mint by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL INDEXING DATA ELEMENTS SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each chewable tablet)

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 take more than 5 chewable tablets in a 24-hour
period

● if pregnant do not take more than 5 tablets in 24 hours

● 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: fully chew then swallow 2 to 4 chewable tablets as symptoms occur, or as directed by a doctor

● children under 12 years: consult a doctor

● do not take more than 5 chewable tablets in a 24-hour period

● if pregnant, do not take more than 5 chewable tablets in 24

hours

Other information

Other information

● each chewable tablet contains: calcium 300 mg

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

● avoid excessive humidity

● close cap tightly after use

INACTIVE INGREDIENT

Inactive ingredients carnauba wax, citric acid, coconut oil, corn syrup, dextrin, FD&C Blue No.1, FD&C Blue No.1 Aluminum Lake, FD&C Red No.40 Aluminum Lake, FD&C Yellow No.6 Aluminum Lake, flavors, glycerin, gum arabic, lecithin, maltodextrin, mono and diglycerides, potassium sorbate, propylene glycol, purified water, shellac, sorbic acid, sucrose, titanium dioxide, vegetable oil, white wax, xylitol

Questions or comments

Questions or comments? 1-800-986-0369

(Mon – Fri 9AM – 5PM EST)

Bottle label 30 tablets

Starts Neutralizing Acid

in Seconds!

NEW

Cooling

Sensation

Alka-Seltzer®

Calcium Carbonate/Antacid

EXTRA STRENGTH

COOL ACTION

HEARTBURN

RELIEFCHEWS®

cool mint

30 Chewable Tablets

INGREDIENTS AND APPEARANCE

ALKA-SELTZER COOL ACTION EXTRA STRENGTH RELIEFCHEWS MINT 
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-0058
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
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
COCONUT OIL (UNII: Q9L0O73W7L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SUCROSE (UNII: C151H8M554)
CORN SYRUP (UNII: 9G5L16BK6N)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
WHITE WAX (UNII: 7G1J5DA97F)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SORBIC ACID (UNII: X045WJ989B)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	blue	Score	no score
Shape	ROUND	Size	18mm
Flavor	MINT	Imprint Code	AS
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-0058-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/03/2019
2	NDC: 0280-0058-50	50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/03/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	03/03/2019

Labeler - Bayer HealthCare LLC. (112117283)