4 Kids Oral Pain Relief

Oyster Shell Calcium Carbonate, Crude, Arabica Coffee Bean, Arnica Montana, Tribasic Calcium Phosphate, Ferrum Phosphoricum And Matricaria Chamomilla

Hyland's Inc.
Human Otc Drug
NDC 54973-3316

4 Kids Oral Pain Relief also known as Oyster Shell Calcium Carbonate, Crude, Arabica Coffee Bean, Arnica Montana, Tribasic Calcium Phosphate, Ferrum Phosphoricum And Matricaria Chamomilla is a human otc drug labeled by 'Hyland's Inc.'. National Drug Code (NDC) number for 4 Kids Oral Pain Relief is 54973-3316. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in 4 Kids Oral Pain Relief drug includes Arabica Coffee Bean - 6 [hp_X]/g Arnica Montana - 30 [hp_X]/g Ferrum Phosphoricum - 12 [hp_X]/g Matricaria Chamomilla - 12 [hp_X]/g Oyster Shell Calcium Carbonate, Crude - 12 [hp_X]/g Tribasic Calcium Phosphate - 12 [hp_X]/g . The currest status of 4 Kids Oral Pain Relief drug is Active.

Drug Information:

Drug NDC:	54973-3316
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 Oral 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:	Oyster Shell Calcium Carbonate, Crude, Arabica Coffee Bean, Arnica Montana, Tribasic Calcium Phosphate, Ferrum Phosphoricum And Matricaria Chamomilla
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:	ARABICA COFFEE BEAN - 6 [hp_X]/g ARNICA MONTANA - 30 [hp_X]/g FERRUM PHOSPHORICUM - 12 [hp_X]/g MATRICARIA CHAMOMILLA - 12 [hp_X]/g OYSTER SHELL CALCIUM CARBONATE, CRUDE - 12 [hp_X]/g TRIBASIC CALCIUM PHOSPHATE - 12 [hp_X]/g
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:	18 Aug, 2017
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.
NUI:	N0000185371 N0000185375 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0516536
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	3SW678MX72 O80TY208ZW 91GQH8I5F7 G0R4UBI2ZZ 2E32821G6I 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:	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] Dietary Proteins [CS] Plant Proteins [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] 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
54973-3316-1	1 BOTTLE, PLASTIC in 1 CARTON (54973-3316-1) / 125 g in 1 BOTTLE, PLASTIC	18 Aug, 2017	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 Oral Pain Relief

Oyster Shell Calcium Carbonate & more..

Tablet
Hyland's Inc.
NDC: 54973-3316

Purpose:

Oral pain relief

Product Elements:

4 kids oral pain relief oyster shell calcium carbonate, crude, arabica coffee bean, arnica montana, tribasic calcium phosphate, ferrum phosphoricum and matricaria chamomilla lactose monohydrate anhydrous lactose acacia oyster shell calcium carbonate, crude oyster shell calcium carbonate, crude arabica coffee bean arabica coffee bean arnica montana arnica montana tribasic calcium phosphate phosphate ion matricaria chamomilla matricaria chamomilla ferrum phosphoricum ferrum phosphoricum

Indications and Usage:

Uses temporarily relieves the symptoms of gum or tooth sensitivity, swelling of gums, tooth and oral pain and discomfort.

Warnings:

As with any drug, ask doctor before use if pregnant or breast-feeding. do not use â¢ more than directed â¢ if your child has a known allergy to any ingredient in this product. consult a physician if: â¢ symptoms persist for more than 72 hours or worsen â¢ swelling increases, rash or fever develops â¢ irritation, pain or redness persists or worsens. 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 band is broken or missing. 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 of age: dissolve 2 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved. children 6 years to under 12 years of age: dissolve 3 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved. adults and children 12 years and over: dissolve 4 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved. hylandâs oral pain relief tablets are very soft and will dissolve instantly in the mouth.

Package Label Principal Display Panel:

Principal display panel - 125 tablet carton new! ndc 54973-3316-1 homeopathic ages 2-12 natural relief since 1903 hyland'sÂ® 4 kids oral pain relief toothache sensitive teeth swelling gums oral disconfort actual size 65 mg 125 quick-dissolving tablets safe & effective carton art

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.