Alka-Seltzer Cool Action Heartburn Relief

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:19:58

Label at a glance#

ProductAlka-Seltzer Cool Action Heartburn Relief 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: 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each chewing piece)

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 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 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

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: 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 SECTION

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

OTC - QUESTIONS SECTION

Questions or comments? 1-800-986-0369

(Mon – Fri 9AM – 5PM EST)

Carton count 16 pieces

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Works Fast!

Alka-Seltzer®

Calcium Carbonate/

Antacid

EXTRA STRENGTH

COOL ACTION

HEARTBURN RELIEF

GUM

cool mint

16 pieces

16 count carton16 count carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2281777calcium carbonate 750 MG Chewing GumPSN7
2281777calcium carbonate 750 MG Chewing GumSCD7

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130016500586074GTIN-13: 0016500586074
EAN-13: 0016500586074
GTIN-12: 016500586074
UPC-A: 016500586074
GTIN storage (14 digits): 00016500586074
C00009373_AS_16ct_Ctn_R (1) - proof report_Page_1.jpg

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
0280-0001-01Alka-Seltzer Cool Action Heartburn ReliefMint2 in 1 CARTONGUM, CHEWING27
0280-0001-01Alka-Seltzer Cool Action Heartburn ReliefMint8 in 1 BLISTER PACKGUM, CHEWING87
0280-0001-02Alka-Seltzer Cool Action Heartburn ReliefMint8 in 1 BLISTER PACKGUM, CHEWING87
0280-0001-02Alka-Seltzer Cool Action Heartburn ReliefMint1 in 1 CARTONGUM, CHEWING17
0280-0001-03Alka-Seltzer Cool Action Heartburn ReliefMint1 in 1 POUCHGUM, CHEWING17
0280-0001-04Alka-Seltzer Cool Action Heartburn ReliefMint10 in 1 BLISTER PACKGUM, CHEWING107
0280-0001-04Alka-Seltzer Cool Action Heartburn ReliefMint6 in 1 CARTONGUM, CHEWING67

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-00010280-0001-01, 0280-0001-02, 0280-0001-03, 0280-0001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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 Heartburn Relief MintCALCIUM CARBONATEBayer HealthCare LLC.9b8da147-8d0c-e6b0-e053-2a95a90a35e62025-12-04WarningsExact identifier
ndc (package): 0280-0001-01
ndc (package): 0280-0001-03
ndc (package): 0280-0001-04
ndc (package): 0280-0001-02
ndc (product): 0280-0001
ndc11 (package): 00280000101
ndc11 (package): 00280000102
ndc11 (package): 00280000104
ndc11 (package): 00280000103
spl id: 452374f2-bab8-ec4e-e063-6294a90adca9
spl set id: 9b8da147-8d0c-e6b0-e053-2a95a90a35e6

Reported adverse events (FAERS/openFDA)#

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