Tummy Ache 4kids

Silver Nitrate, Asafetida, Activated Charcoal, Matricaria Recutita, Cinchona Officinalis Bark, Citrullus Colocynthis Fruit Pulp, Lycopodium Clavatum Spore, Nutmeg, And Pulsatilla Vulgaris

Hyland's Inc.
Human Otc Drug
NDC 54973-3196

Tummy Ache 4kids also known as Silver Nitrate, Asafetida, Activated Charcoal, Matricaria Recutita, Cinchona Officinalis Bark, Citrullus Colocynthis Fruit Pulp, Lycopodium Clavatum Spore, Nutmeg, And Pulsatilla Vulgaris is a human otc drug labeled by 'Hyland's Inc.'. National Drug Code (NDC) number for Tummy Ache 4kids is 54973-3196. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Tummy Ache 4kids drug includes Activated Charcoal - 12 [hp_X]/1 Asafetida - 6 [hp_X]/1 Cinchona Officinalis Bark - 6 [hp_X]/1 Citrullus Colocynthis Fruit Pulp - 6 [hp_X]/1 Lycopodium Clavatum Spore - 30 [hp_X]/1 Matricaria Recutita - 6 [hp_X]/1 Nutmeg - 6 [hp_X]/1 Pulsatilla Vulgaris - 6 [hp_X]/1 Silver Nitrate - 6 [hp_X]/1 . The currest status of Tummy Ache 4kids drug is Active.

Drug Information:

Drug NDC:	54973-3196
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Tummy Ache 4kids
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Silver Nitrate, Asafetida, Activated Charcoal, Matricaria Recutita, Cinchona Officinalis Bark, Citrullus Colocynthis Fruit Pulp, Lycopodium Clavatum Spore, Nutmeg, And Pulsatilla Vulgaris
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Hyland's Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	ACTIVATED CHARCOAL - 12 [hp_X]/1 ASAFETIDA - 6 [hp_X]/1 CINCHONA OFFICINALIS BARK - 6 [hp_X]/1 CITRULLUS COLOCYNTHIS FRUIT PULP - 6 [hp_X]/1 LYCOPODIUM CLAVATUM SPORE - 30 [hp_X]/1 MATRICARIA RECUTITA - 6 [hp_X]/1 NUTMEG - 6 [hp_X]/1 PULSATILLA VULGARIS - 6 [hp_X]/1 SILVER NITRATE - 6 [hp_X]/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	20 Oct, 2014
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	05 May, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Hyland's Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000185371 N0000185375 N0000175629 N0000184306 M0000728 M0016962 M0006342 M0008672 M0516536
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	2P3VWU3H10 W9FZA51AS1 S003A158SB 23H32AOH17 C88X29Y479 G0R4UBI2ZZ AEE24M3MQ9 I76KB35JEV 95IT3W8JZE
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Increased Histamine Release [PE] Cell-mediated Immunity [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Allergens [CS] Plant Proteins [CS] Dietary Proteins [CS] Food Additives [CS] Seed Storage Proteins [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Allergens [CS] Cell-mediated Immunity [PE] Dietary Proteins [CS] Food Additives [CS] Increased Histamine Release [PE] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] Seed Storage Proteins [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
54973-3196-1	1 BOTTLE, PLASTIC in 1 CARTON (54973-3196-1) / 50 TABLET in 1 BOTTLE, PLASTIC	20 Oct, 2014	N/A	No
54973-3196-3	4 TABLET in 1 PACKET (54973-3196-3)	20 Oct, 2014	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Tummy Ache 4kids

Silver Nitrate & more..

Tablet
Hyland's Inc.
NDC: 54973-3196

Purpose:

Temporarily relieves minor abdominal and stomach pain, upset stomach due to nervousness, stomach pressure and cramps, gas, nausea, and diarrhea.

Product Elements:

Tummy ache 4kids silver nitrate, asafetida, activated charcoal, matricaria recutita, cinchona officinalis bark, citrullus colocynthis fruit pulp, lycopodium clavatum spore, nutmeg, and pulsatilla vulgaris acacia lactose silver nitrate silver cation asafetida asafetida activated charcoal activated charcoal matricaria recutita matricaria recutita cinchona officinalis bark cinchona officinalis bark citrullus colocynthis fruit pulp citrullus colocynthis fruit pulp lycopodium clavatum spore lycopodium clavatum spore nutmeg nutmeg pulsatilla vulgaris pulsatilla vulgaris

Indications and Usage:

Uses temporarily relieves the symptoms of: â¢ minor abdominal or stomach pain â¢ upset stomach due to nervousness â¢ stomach pressure or cramps â¢ gas â¢ nausea â¢ diarrhe

Warnings:

Warnings as with any drug, ask a doctor before use if pregnant or breast-feeding. consult a physician if: fever develops diarrhea lasts for more than 2 days worsens other symptoms persist for more than 7 days or worsen keep this and all medications out of the reach of children. in case of accidental overdose, contact a medical professional or poison control center immediately. do not use if imprinted tamper-evident bottle cap band is broken or missing. the inner packaged bottle is child-resistant. in case of emergency, contact a medical professional or poison control center immediately. hylandâs may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Do Not Use:

Dosage and Administration:

Directions children 2 years to under 6 years dissolve 1 tablet under tongue every 15 minutes for up to 6 doses until relieved; then every 4 hours as required children 6 years to under 12 years dissolve 2 tablets under tongue every 15 minutes for up to 6 doses until relieved; then every 4 hours as required adults and children 12 years and over dissolve 3 tablets under tongue every 15 minutes for up to 6 doses until relieved; then every 4 hours as required

Package Label Principal Display Panel:

Principal display panel - 50 tablet bottle carton ndc 54973-3196-1 homeopathic natural relief ages 2-12 since 1903 hyland's 4kids tummy ache* upset stomach due to nervousness stomach pain diarrhea gas 50 quick-dissolving tablets actual size 194 mg *see note on back panel below drug facts carton

Further Questions:

Questions or comments? (800) 624-9659

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.