4 Kids Sore Throat Grape

Spongia Officinalis Skeleton, Roasted, Aconitum Napellus, Phosphorus, Calcium Sulfide And Ferrosoferric Phosphate

Hyland's Inc.
Human Otc Drug
NDC 54973-4020

4 Kids Sore Throat Grape also known as Spongia Officinalis Skeleton, Roasted, Aconitum Napellus, Phosphorus, Calcium Sulfide And Ferrosoferric Phosphate is a human otc drug labeled by 'Hyland's Inc.'. National Drug Code (NDC) number for 4 Kids Sore Throat Grape is 54973-4020. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in 4 Kids Sore Throat Grape drug includes Aconitum Napellus - 15 [hp_X]/mL Calcium Sulfide - 12 [hp_X]/mL Ferrosoferric Phosphate - 12 [hp_X]/mL Phosphorus - 9 [hp_X]/mL Spongia Officinalis Skeleton, Roasted - 12 [hp_X]/mL . The currest status of 4 Kids Sore Throat Grape drug is Active.

Drug Information:

Drug NDC:	54973-4020
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:	4 Kids Sore Throat Grape
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:	Spongia Officinalis Skeleton, Roasted, Aconitum Napellus, Phosphorus, Calcium Sulfide And Ferrosoferric Phosphate
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:	Liquid
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:	ACONITUM NAPELLUS - 15 [hp_X]/mL CALCIUM SULFIDE - 12 [hp_X]/mL FERROSOFERRIC PHOSPHATE - 12 [hp_X]/mL PHOSPHORUS - 9 [hp_X]/mL SPONGIA OFFICINALIS SKELETON, ROASTED - 12 [hp_X]/mL
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:	14 Feb, 2020
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.
UNII:	U0NQ8555JD 1MBW07J51Q 91GQH8I5F7 27YLU75U4W 1PIP394IID
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.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
54973-4020-1	1 BOTTLE, PLASTIC in 1 CARTON (54973-4020-1) / 118 mL in 1 BOTTLE, PLASTIC	14 Feb, 2020	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

4 Kids Sore Throat Grape

Spongia Officinalis Skeleton & more..

Liquid
Hyland's Inc.
NDC: 54973-4020

Purpose:

Purpose sore throat sore throat sore throat pain in throat sore throat

Product Elements:

4 kids sore throat grape spongia officinalis skeleton, roasted, aconitum napellus, phosphorus, calcium sulfide and ferrosoferric phosphate calcium sulfide calcium sulfide phosphorus phosphorus aconitum napellus aconitum napellus spongia officinalis skeleton, roasted spongia officinalis skeleton, roasted glycyrrhiza glabra sodium benzoate water citric acid monohydrate glycerin ferrosoferric phosphate ferrosoferric phosphate

Indications and Usage:

Uses temporarily relieves sore throat symptoms in children, including: occasional minor irritation ï® pain

Warnings:

Warnings as with any drug, ask a doctor before use if pregnant or breast-feeding. do not use more than directed consult a physician if: symptoms persist for more than 7 days or worsen. inflammation, fever or infection develops. symptoms are accompanied by a high fever (over 101Â°f). keep this and all medications out of the reach of children. sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. consult a doctor promptly. in case of emergency or accidental overdose, 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.

Dosage and Administration:

Directions shake well before using. measure only with the dosing cup provided. do not use dosing cup with other products. on dosing cup, ml = milliliter. children 2 years to under 6 years 5 ml up to 6 times per day (every 4 hours). children 6 years to under 12 years 10 ml up to 6 times per day (every 4 hours). adults and children 12 years and over 15 ml up to 6 times per day (every 4 hours).

Package Label Principal Display Panel:

Principal display panel - 118 ml bottle carton homeopathic ndc 54973-4020-1 2-12 years new 4 kids since 1903 hyland's sore throat* relieves minor sore throat pain and irritation no alcohol or parabens no sugar or dyes natural relief natural grape flavor 4 fl. oz (118 ml) *see note on side 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.