NDC 0280-0051 Alka-seltzer Kids Tummy Reliefchews

Calcium Carbonate And Dimethicone

NDC Product Code 0280-0051

NDC CODE: 0280-0051

Proprietary Name: Alka-seltzer Kids Tummy Reliefchews 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 And Dimethicone 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.

Product Characteristics

Color(s):
PINK (C48328)
Shape: ROUND (C48348)
Size(s):
18 MM
Imprint(s):
HG
Score: 1
Flavor(s):
FRUIT PUNCH (C73390)

NDC Code Structure

  • 0280 - Bayer Healthcare Llc.
    • 0280-0051 - Alka-seltzer Kids Tummy Reliefchews

NDC 0280-0051-01

Package Description: 28 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

NDC Product Information

Alka-seltzer Kids Tummy Reliefchews with NDC 0280-0051 is a a human over the counter drug product labeled by Bayer Healthcare Llc.. The generic name of Alka-seltzer Kids Tummy Reliefchews is calcium carbonate and dimethicone. 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 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 Kids Tummy Reliefchews 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.

  • CALCIUM CARBONATE 750 mg/1
  • DIMETHICONE 80 mg/1

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.

  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIACETIN (UNII: XHX3C3X673)
  • MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
  • WATER (UNII: 059QF0KO0R)
  • WHITE WAX (UNII: 7G1J5DA97F)
  • SHELLAC (UNII: 46N107B71O)
  • ACACIA (UNII: 5C5403N26O)
  • CORN SYRUP (UNII: 9G5L16BK6N)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SORBIC ACID (UNII: X045WJ989B)
  • SORBITOL (UNII: 506T60A25R)

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.

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: 03-01-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Alka-seltzer Kids Tummy Reliefchews Product Label Images

Alka-seltzer Kids Tummy Reliefchews 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

Other

Drug Facts

Active Ingredients And Purpoose

Active ingredients (in each chewable tablet) Purpose
Calcium carbonate 750 mg….................................….…...Antacid

Simethicone 80 mg……………………………………….......Antigas

Indications & Usage

Uses for the relief of:

● acid indigestion ● heartburn ● sour stomach

● upset stomach associated with these symptoms

● bloating, pressure, or stuffed feeling commonly referred to as gas

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
● adults and children 12 years and over do not take more than 6 chewable tablets in a 24-hour period

● children 6 to under 12 years do not take more than 4 chewable tablets in a 24-hour period

● if pregnant, do not take more than 6 chewable 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

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.

Dosage & Administration

  • Directionsadults and children 12 years and over • fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a doctor.
  • • do not take more than 6 chewable tablets in a 24-hour period
  • Children 6 years to under 12 years • under adult supervision, fully chew then swallow 1 chewable tablet as symptoms occur, or as directed by a doctor.
  • • do not take more than 4 chewable tablets in a 24-hour period
  • Children under 6 yearsconsult a doctorif pregnant, do not take more than 6 chewable tablets in 24 hours

Other Safety Information

Other information● each chewable tablet contains: calcium 300 mg

● store at room temperature. Avoid excessive heat above 40°C (104°F).

● close cap tightly after use

Inactive Ingredient

Inactive ingredients acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, FD&C red No.40 aluminum lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, maltodextrin, modified starch, potassium hydroxide, pregelatinized modified starch, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, sucrose, titanium dioxide, triacetin, water, white wax

Otc - Questions

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

Package Label 28 Count

WorksAmazingly Fast!Alka-Seltzer® KidsTummy ReliefChews®Calcium Carbonate/AntiacidSimethicone/Antigas•6 Symptom Relief••Upset Stomach•Gas • Bloating•Acid Indigestion•Heartburn•Upset StomachFRUIT PUNCH28 CHEWABLE TABLETS

* Please review the disclaimer below.