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NDC 54973-3196 Tummy Ache 4kids

Silver Nitrate,Asafetida,Activated Charcoal,Matricaria Recutita,Cinchona Officinalis - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54973-3196?
  5. Tummy Ache 4kids Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes

Product Information

NDC Product Code:
54973-3196
Proprietary Name:
Tummy Ache 4kids
Non-Proprietary Name: [1]
Silver Nitrate, Asafetida, Activated Charcoal, Matricaria Recutita, Cinchona Officinalis Bark, Citrullus Colocynthis Fruit Pulp, Lycopodium Clavatum Spore, Nutmeg, And Pulsatilla Vulgaris
Substance Name: [2]
Activated Charcoal; Asafetida; Cinchona Officinalis Bark; Citrullus Colocynthis Fruit Pulp; Lycopodium Clavatum Spore; Matricaria Recutita; Nutmeg; Pulsatilla Vulgaris; Silver Nitrate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Hyland's Inc.
    Labeler Code:
    54973
    Product Label ID:
    987988e0-e67e-4d46-b117-5ffa126885ff
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    10-20-2014
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)
    Shape:
    ROUND (C48348)
    Size(s):
    9 MM
    Score:
    1

    Product Packages

    NDC Code 54973-3196-1

    Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 50 TABLET in 1 BOTTLE, PLASTIC

    NDC Code 54973-3196-3

    Package Description: 4 TABLET in 1 PACKET

    Product Details

    What is NDC 54973-3196?

    The NDC code 54973-3196 is assigned by the FDA to the product Tummy Ache 4kids which is a human over the counter drug product labeled by Hyland's Inc.. The generic name of Tummy Ache 4kids is silver nitrate, asafetida, activated charcoal, matricaria recutita, cinchona officinalis bark, citrullus colocynthis fruit pulp, lycopodium clavatum spore, nutmeg, and pulsatilla vulgaris. The product's dosage form is tablet and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 54973-3196-1 1 bottle, plastic in 1 carton / 50 tablet in 1 bottle, plastic, 54973-3196-3 4 tablet in 1 packet . 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 Tummy Ache 4kids?

    Children 2 years to under 6 yearsdissolve 1 tablet under tongue every 15 minutes for up to 6 doses until relieved; then every 4 hours as requiredchildren 6 years to under 12 yearsdissolve 2 tablets under tongue every 15 minutes for up to 6 doses until relieved; then every 4 hours as requiredadults and children 12 years and overdissolve 3 tablets under tongue every 15 minutes for up to 6 doses until relieved; then every 4 hours as required

    What are Tummy Ache 4kids 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.

    Which are Tummy Ache 4kids UNII Codes?

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

    Which are Tummy Ache 4kids 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:

    Which are the Pharmacologic Classes for Tummy Ache 4kids?

    * 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.

    [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".