NDC 0280-0051 Alka-seltzer Kids Tummy Reliefchews

Calcium Carbonate And Dimethicone Tablet, Chewable Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0280-0051
Proprietary Name:
Alka-seltzer Kids Tummy Reliefchews
Non-Proprietary Name: [1]
Calcium Carbonate And Dimethicone
Substance Name: [2]
Calcium Carbonate; Dimethicone
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Bayer Healthcare Llc.
    Labeler Code:
    0280
    FDA Application Number: [6]
    M001
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    03-01-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

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

    Product Packages

    NDC Code 0280-0051-01

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

    Product Details

    What is NDC 0280-0051?

    The NDC code 0280-0051 is assigned by the FDA to the product Alka-seltzer Kids Tummy Reliefchews which is 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. The product is distributed in a single package with assigned NDC code 0280-0051-01 28 tablet, chewable in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Alka-seltzer Kids Tummy Reliefchews?

    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

    What are Alka-seltzer Kids Tummy Reliefchews Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • CALCIUM CARBONATE 750 mg/1 - Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.
    • DIMETHICONE 80 mg/1

    Which are Alka-seltzer Kids Tummy Reliefchews UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Alka-seltzer Kids Tummy Reliefchews Inactive Ingredients UNII Codes?

    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. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Alka-seltzer Kids Tummy Reliefchews?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:
    • RxCUI: 1492387 - calcium carbonate 750 MG / simethicone 80 MG Chewable Tablet

    Which are the Pharmacologic Classes for Alka-seltzer Kids Tummy Reliefchews?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Calcium Carbonate


    Calcium carbonate is a dietary supplement used when the amount of calcium taken in the diet is not enough. Calcium is needed by the body for healthy bones, muscles, nervous system, and heart. Calcium carbonate also is used as an antacid to relieve heartburn, acid indigestion, and upset stomach. It is available with or without a prescription. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
    [Learn More]


    Simethicone


    Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

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

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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".