NDC 0280-0001 Alka-seltzer Cool Action Heartburn Relief Mint

Calcium Carbonate

NDC Product Code 0280-0001

NDC CODE: 0280-0001

Proprietary Name: Alka-seltzer Cool Action Heartburn Relief Mint What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Calcium Carbonate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat symptoms caused by too much stomach acid such as heartburn, upset stomach, or indigestion. It is an antacid that works by lowering the amount of acid in the stomach. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

NDC Code Structure

  • 0280 - Bayer Healthcare Llc.
    • 0280-0001 - Alka-seltzer Cool Action Heartburn Relief

NDC 0280-0001-01

Package Description: 2 BLISTER PACK in 1 CARTON > 8 GUM, CHEWING in 1 BLISTER PACK

NDC Product Information

Alka-seltzer Cool Action Heartburn Relief Mint with NDC 0280-0001 is a a human over the counter drug product labeled by Bayer Healthcare Llc.. The generic name of Alka-seltzer Cool Action Heartburn Relief Mint is calcium carbonate. The product's dosage form is gum, chewing and is administered via oral form.

Labeler Name: Bayer Healthcare Llc.

Dosage Form: Gum, Chewing - A sweetened and flavored insoluble plastic material of various shapes which when chewed, releases a drug substance into the oral cavity.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Alka-seltzer Cool Action Heartburn Relief Mint Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ISOMALT (UNII: S870P55O2W)
  • SORBITOL (UNII: 506T60A25R)
  • COPOVIDONE K25-31 (UNII: D9C330MD8B)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bayer Healthcare Llc.
Labeler Code: 0280
FDA Application Number: part331 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Alka-seltzer Cool Action Heartburn Relief Mint Product Label Images

Alka-seltzer Cool Action Heartburn Relief Mint Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index


Drug Facts

Otc - Active Ingredient

Active ingredient (in each chewing piece) Calcium carbonate 750 mg

Otc - Purpose



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



Otc - Do Not Use

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

Otc - Ask Doctor

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

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

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.


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

Otc - Questions

Questions or comments? 1-800-986-0369
(Mon – Fri 9AM – 5PM EST)

Carton Count 16 Pieces

Works Fast!Alka-Seltzer®Calcium Carbonate/AntacidEXTRA STRENGTHCOOL ACTIONHEARTBURN RELIEFGUMcool mint16 pieces

* Please review the disclaimer below.