4 Kids Leg Pain Relief

Tribasic Calcium Phosphate, Arnica Montana, Oyster Shell Calcium Carbonate, Crude, Copper, Eupatorium Perfoliatum Flowering Top, Magnesium Phosphate, Dibasic Trihydrate, Phosphorus, Guaiacum Officinale Resin And Phosphoric Acid

Hyland's Inc.
Human Otc Drug
NDC 54973-3383

4 Kids Leg Pain Relief also known as Tribasic Calcium Phosphate, Arnica Montana, Oyster Shell Calcium Carbonate, Crude, Copper, Eupatorium Perfoliatum Flowering Top, Magnesium Phosphate, Dibasic Trihydrate, Phosphorus, Guaiacum Officinale Resin And Phosphoric Acid is a human otc drug labeled by 'Hyland's Inc.'. National Drug Code (NDC) number for 4 Kids Leg Pain Relief is 54973-3383. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in 4 Kids Leg Pain Relief drug includes Arnica Montana - 30 [hp_X]/1 Copper - 12 [hp_X]/1 Eupatorium Perfoliatum Flowering Top - 30 [hp_X]/1 Guaiacum Officinale Resin - 12 [hp_X]/1 Magnesium Phosphate, Dibasic Trihydrate - 12 [hp_X]/1 Oyster Shell Calcium Carbonate, Crude - 12 [hp_X]/1 Phosphoric Acid - 12 [hp_X]/1 Phosphorus - 12 [hp_X]/1 Tribasic Calcium Phosphate - 12 [hp_X]/1 . The currest status of 4 Kids Leg Pain Relief drug is Active.

Drug Information:

Drug NDC:	54973-3383
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 Leg Pain Relief
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:	Tribasic Calcium Phosphate, Arnica Montana, Oyster Shell Calcium Carbonate, Crude, Copper, Eupatorium Perfoliatum Flowering Top, Magnesium Phosphate, Dibasic Trihydrate, Phosphorus, Guaiacum Officinale Resin And Phosphoric Acid
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:	ARNICA MONTANA - 30 [hp_X]/1 COPPER - 12 [hp_X]/1 EUPATORIUM PERFOLIATUM FLOWERING TOP - 30 [hp_X]/1 GUAIACUM OFFICINALE RESIN - 12 [hp_X]/1 MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE - 12 [hp_X]/1 OYSTER SHELL CALCIUM CARBONATE, CRUDE - 12 [hp_X]/1 PHOSPHORIC ACID - 12 [hp_X]/1 PHOSPHORUS - 12 [hp_X]/1 TRIBASIC CALCIUM PHOSPHATE - 12 [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:	01 Nov, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	07 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.
UPC:	0354973338319
UPC stands for Universal Product Code.
NUI:	M0005152 N0000175831 N0000008595 N0000008924 N0000175830
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	O80TY208ZW 789U1901C5 1W0775VX6E N0K2Z502R6 HF539G9L3Q 2E32821G6I E4GA8884NN 27YLU75U4W 91D9GV0Z28
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:	Copper-containing Intrauterine Device [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:	Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Inhibit Ovum Fertilization [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:	Copper [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:	Calculi Dissolution Agent [EPC] Copper [CS] Copper-containing Intrauterine Device [EPC] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Increased Large Intestinal Motility [PE] Inhibit Ovum Fertilization [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Inhibition Small Intestine Fluid/Electrolyte Absorption [PE] Magnesium Ion Exchange Activity [MoA] Osmotic Activity [MoA] Osmotic Laxative [EPC] Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
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
54973-3383-1	1 BOTTLE, PLASTIC in 1 CARTON (54973-3383-1) / 50 TABLET in 1 BOTTLE, PLASTIC	01 Nov, 2018	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 Leg Pain Relief

Tribasic Calcium Phosphate & more..

Tablet
Hyland's Inc.
NDC: 54973-3383

Purpose:

Purpose arnica montana 30x hpus ..............................muscle soreness, stiffness and pain calcarea carbonica 12x hpus............................................cramps and pain in legs calcarea phosphorica 12x hpus................. aching pain in limbs, cramps in calves cuprum metallicum 12x hpus........................pain in legs and calves when resting eupatorium perfoliatum 30x hpus ................... soreness of limbs, aching in limbs guaiacum 12x hpus ..............................................................muscle and joint pain magnesia phosphorica 12x hpus ...................................pain and cramps in calves phosphoricum acidum 12x hpus....pain in thighs, cramps in thighs, legs and feet phosphorus 12x hpus...............................cramps in legs, knees extending to feet

Product Elements:

4 kids leg pain relief tribasic calcium phosphate, arnica montana, oyster shell calcium carbonate, crude, copper, eupatorium perfoliatum flowering top, magnesium phosphate, dibasic trihydrate, phosphorus, guaiacum officinale resin and phosphoric acid lactose monohydrate anhydrous lactose acacia tribasic calcium phosphate phosphate ion arnica montana arnica montana oyster shell calcium carbonate, crude oyster shell calcium carbonate, crude copper copper eupatorium perfoliatum flowering top eupatorium perfoliatum flowering top guaiacum officinale resin guaiacum officinale resin phosphorus phosphorus magnesium phosphate, dibasic trihydrate magnesium cation phosphoric acid phosphoric acid white to off white

Indications and Usage:

Uses temporarily relieves the symptoms of: â¢ minor leg pain â¢ muscle soreness and stiffness â¢ aching pain and soreness in limbs â¢ pain and cramps in calves, joints, thighs, knees and feet

Warnings:

Warnings as with any drug, ask doctor before use if pregnant or breast-feeding. do not use â¢ more than directed. â¢ if you have a known allergy to any ingredient in this product. consult a physician if symptoms persist for more than 7 days or worsen. keep this and all medications out of 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 2 tablets under tongue every 15 minutes for up to 4 doses until relieved, then every 6 hours as required. children 6 years to under 12 years dissolve 3 tablets under tongue every 15 minutes for up to 4 doses until relieved, then every 6 hours as required. adults and children 12 years and over dissolve 4 tablets under tongue every 15 minutes, for up to 4 doses until relieved, then every 6 hours as required.

Package Label Principal Display Panel:

Principal display panel - 50 tablet bottle carton new! ndc 54973-3383-1 homeopathic natural relief ages 2-12 since 1903 hyland's 4 kids leg pain relief* muscle aches & soreness pain & stiffnes leg cramps 50 quick-dissolving tablets actual size 194 mg size 194 mg 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.