FDA.reportPublic FDA data

Alka-Seltzer Cool Action Extra Strength ReliefChews Mint

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:19:56

Label at a glance#

ProductAlka-Seltzer Cool Action Extra Strength ReliefChews Mint
Active ingredientCALCIUM CARBONATE
Label structure10 sections

Indications and uses

Uses for the relief of: ● acid indigestion ● heartburn ● sour stomach ● upset stomach associated with these symptoms

Dosage and administration

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

Label contents#

Full prescribing information#

SPL INDEXING DATA ELEMENTS SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each chewable tablet)

Calcium carbonate 750 mg

OTC - PURPOSE SECTION

Purpose

Antacid

Uses

INDICATIONS & USAGE SECTION

Uses for the relief of:

● acid indigestion ● heartburn ● sour stomach

● upset stomach associated with these symptoms

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

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 SAFETY 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 SECTION

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

OTC - QUESTIONS SECTION

Questions or comments? 1-800-986-0369

(Mon – Fri 9AM – 5PM EST)

Bottle label 30 tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Starts Neutralizing Acid

in Seconds!

NEW

Cooling

Sensation

Alka-Seltzer®

Calcium Carbonate/Antacid

EXTRA STRENGTH

COOL ACTION

HEARTBURN

RELIEFCHEWS®

cool mint

30 Chewable Tablets

AS Cool Action Relief Chews Mint bottle labelAS Cool Action Relief Chews Mint bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN6
308915calcium carbonate 750 MG Chewable TabletSCD6
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0058-30Alka-Seltzer Cool Action Extra Strength ReliefChews Mint30 in 1 BOTTLE, PLASTICTABLET, CHEWABLE306
0280-0058-50Alka-Seltzer Cool Action Extra Strength ReliefChews Mint50 in 1 BOTTLE, PLASTICTABLET, CHEWABLE506

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-00580280-0058-30, 0280-0058-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
CORN SYRUP9G5L16BK6NIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SHELLAC46N107B71OIACT
WHITE WAX7G1J5DA97FIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C BLUE NO. 1--ALUMINUM LAKEJ9EQA3S2JMIACT
MALTODEXTRIN7CVR7L4A2DIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SUCROSEC151H8M554IACT
SORBIC ACIDX045WJ989BIACT
XYLITOLVCQ006KQ1EIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CALCIUM CARBONATEH0G9379FGKACTIB
CARNAUBA WAXR12CBM0EIZIACT
COCONUT OILQ9L0O73W7LIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Cool Action Extra Strength ReliefChews MintCALCIUM CARBONATEBayer HealthCare LLC.849bd52a-b730-3ba7-e053-2a91aa0a507c2025-12-04WarningsExact identifier
ndc (package): 0280-0058-50
ndc (package): 0280-0058-30
ndc (product): 0280-0058
ndc11 (package): 00280005850
ndc11 (package): 00280005830
spl id: 45262c76-563b-6aee-e063-6394a90af808
spl set id: 849bd52a-b730-3ba7-e053-2a91aa0a507c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.