NDC 0280-0058 Alka-seltzer Cool Action Extra Strength Reliefchews Mint

Calcium Carbonate

NDC Product Code 0280-0058

NDC Code: 0280-0058

Proprietary Name: Alka-seltzer Cool Action Extra Strength Reliefchews Mint Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.


Product Characteristics
Color(s):
BLUE (C48333)
Shape: ROUND (C48348)
Size(s):
18 MM
Imprint(s):
AS
Score: 1
Flavor(s):
MINT (C73404)

Code Structure
  • 0280 - Bayer Healthcare Llc.
    • 0280-0058 - Alka-seltzer Cool Action Extra Strength Reliefchews Mint

NDC 0280-0058-30

Package Description: 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

NDC 0280-0058-50

Package Description: 50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

NDC Product Information

Alka-seltzer Cool Action Extra Strength Reliefchews Mint with NDC 0280-0058 is a a human over the counter drug product labeled by Bayer Healthcare Llc.. The generic name of Alka-seltzer Cool Action Extra Strength Reliefchews Mint is calcium carbonate. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Bayer Healthcare Llc.

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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 Extra Strength Reliefchews Mint Active Ingredient(s)

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

  • CALCIUM CARBONATE 750 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • 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)

Administration Route(s)

Additional informationCallout TooltipWhat 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.

Product Labeler Information

Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 03-03-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Extra Strength Reliefchews Mint Product Label Images

Alka-seltzer Cool Action Extra Strength Reliefchews 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

Spl Indexing Data Elements

Drug Facts

Otc - Active Ingredient

Active ingredient (in each chewable tablet)Calcium carbonate 750 mg

Otc - Purpose

PurposeAntacid

Uses

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

Warnings

Warnings

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/Pharmacist

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 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 morethan 2 weeks except under the advice and supervision of aphysician

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

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

Bottle Label 30 Tablets

Starts Neutralizing Acidin Seconds!NEWCoolingSensationAlka-Seltzer®Calcium Carbonate/AntacidEXTRA STRENGTHCOOL ACTIONHEARTBURNRELIEFCHEWS®cool mint30 Chewable Tablets

* Please review the disclaimer below.

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