4 Kids Pain Relief Grape

Aconitum Napellus, Toxicodendron Pubescens Leaf, Anemone Pulsatilla, Gelsemium Sempervirens Root, Arnica Montana, Eupatorium Perfoliatum Flowering Top, Bryonia Alba Root And Phosphorus

Hyland's Inc.
Human Otc Drug
NDC 54973-4018

4 Kids Pain Relief Grape also known as Aconitum Napellus, Toxicodendron Pubescens Leaf, Anemone Pulsatilla, Gelsemium Sempervirens Root, Arnica Montana, Eupatorium Perfoliatum Flowering Top, Bryonia Alba Root And Phosphorus is a human otc drug labeled by 'Hyland's Inc.'. National Drug Code (NDC) number for 4 Kids Pain Relief Grape is 54973-4018. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in 4 Kids Pain Relief Grape drug includes Aconitum Napellus - 30 [hp_X]/mL Anemone Pulsatilla - 9 [hp_X]/mL Arnica Montana - 30 [hp_X]/mL Bryonia Alba Root - 30 [hp_X]/mL Eupatorium Perfoliatum Flowering Top - 30 [hp_X]/mL Gelsemium Sempervirens Root - 12 [hp_X]/mL Phosphorus - 12 [hp_X]/mL Toxicodendron Pubescens Leaf - 12 [hp_X]/mL . The currest status of 4 Kids Pain Relief Grape drug is Active.

Drug Information:

Drug NDC:	54973-4018
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 Pain Relief 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:	Aconitum Napellus, Toxicodendron Pubescens Leaf, Anemone Pulsatilla, Gelsemium Sempervirens Root, Arnica Montana, Eupatorium Perfoliatum Flowering Top, Bryonia Alba Root And Phosphorus
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 - 30 [hp_X]/mL ANEMONE PULSATILLA - 9 [hp_X]/mL ARNICA MONTANA - 30 [hp_X]/mL BRYONIA ALBA ROOT - 30 [hp_X]/mL EUPATORIUM PERFOLIATUM FLOWERING TOP - 30 [hp_X]/mL GELSEMIUM SEMPERVIRENS ROOT - 12 [hp_X]/mL PHOSPHORUS - 12 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF - 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:	27 Jan, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	10 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 I76KB35JEV O80TY208ZW T7J046YI2B 1W0775VX6E 639KR60Q1Q 27YLU75U4W 6IO182RP7A
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
54973-4018-1	1 BOTTLE, PLASTIC in 1 CARTON (54973-4018-1) / 118 mL in 1 BOTTLE, PLASTIC	27 Jan, 2020	N/A	No
54973-4018-3	1 BOTTLE, PLASTIC in 1 CARTON (54973-4018-3) / 148 mL in 1 BOTTLE, PLASTIC	27 Jan, 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 Pain Relief Grape

Aconitum Napellus & more..

Liquid
Hyland's Inc.
NDC: 54973-4018

Purpose:

Purpose headache, back pain,minor pain in joints muscle aches, pain back pain, minor pain in joints pain in back and limbs muscle aches/pain, headache minor pain in joints, headache toothache, minor pain in joints stiffness, minor pain in joints, cramps

Product Elements:

4 kids pain relief grape aconitum napellus, toxicodendron pubescens leaf, anemone pulsatilla, gelsemium sempervirens root, arnica montana, eupatorium perfoliatum flowering top, bryonia alba root and phosphorus citric acid monohydrate glycyrrhiza glabra water sodium benzoate phosphorus phosphorus anemone pulsatilla anemone pulsatilla toxicodendron pubescens leaf toxicodendron pubescens leaf arnica montana arnica montana bryonia alba root bryonia alba root aconitum napellus aconitum napellus gelsemium sempervirens root gelsemium sempervirens root eupatorium perfoliatum flowering top eupatorium perfoliatum flowering top

Indications and Usage:

Uses temporarily relieves minor pain symptoms in children, including: muscle aches ï® toothache ï® headache cramps ï® stiffness ï® back pain pain in joints or limbs

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 48 hours or worsen.ï® 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. 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 every 15 minutes for 4 doses, then every 4 hours until relieved. children 6 years to under 12 years 10 ml every 15 minutes for 4 doses, then every 4 hours until relieved. adults and children 12 years and over 15 ml every 15 minutes for 4 doses, then every 4 hours until relieved.

Package Label Principal Display Panel:

Principal display panel - 118 ml bottle carton homeopathic ndc 54973-4018-1 2-12 years new 4 kids since 1903 hyland's pain relief* relieves muscle aches, headache, minor joint pain and toothache no acetaminophen 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.