Tri-vite Drops With Fluoride

Ascorbic Acid, Sodium Fluoride, Vitamin A And Vitamin D

Method Pharmaceuticals, Llc
Human Prescription Drug
NDC 58657-323

Tri-vite Drops With Fluoride also known as Ascorbic Acid, Sodium Fluoride, Vitamin A And Vitamin D is a human prescription drug labeled by 'Method Pharmaceuticals, Llc'. National Drug Code (NDC) number for Tri-vite Drops With Fluoride is 58657-323. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Tri-vite Drops With Fluoride drug includes Ascorbic Acid - 35 mg/mL Sodium Fluoride - .25 mg/mL Vitamin A - 1500 [iU]/mL Vitamin D - 400 [iU]/mL . The currest status of Tri-vite Drops With Fluoride drug is Active.

Drug Information:

Drug NDC:	58657-323
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:	Tri-vite Drops With Fluoride
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription 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:	Ascorbic Acid, Sodium Fluoride, Vitamin A And Vitamin D
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Method Pharmaceuticals, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Solution
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:	ASCORBIC ACID - 35 mg/mL SODIUM FLUORIDE - .25 mg/mL VITAMIN A - 1500 [iU]/mL VITAMIN D - 400 [iU]/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 DRUG OTHER
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:	25 Jul, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	18 Dec, 2025
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:	Method Pharmaceuticals, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1365980
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000193618 M0001797 M0022788 N0000175950
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	PQ6CK8PD0R 8ZYQ1474W7 81G40H8B0T 9VU1KI44GP
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:	Vitamin C [EPC] Vitamin A [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 CS:	Ascorbic Acid [CS] Vitamin A [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:	Ascorbic Acid [CS] Vitamin A [CS] Vitamin A [EPC] Vitamin C [EPC]
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
58657-323-50	1 BOTTLE, DROPPER in 1 CARTON (58657-323-50) / 50 mL in 1 BOTTLE, DROPPER	25 Jul, 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.

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Tri-vite Drops With Fluoride

Ascorbic Acid, Sodium Fluoride, Vitamin A And Vitamin D

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NDC: 58657-323

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Tri-vite Drops With Fluoride

Ascorbic Acid, Sodium Fluoride, Vitamin A And Vitamin D

Solution
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NDC: 58657-324

Product Elements:

Tri-vite drops with fluoride ascorbic acid, sodium fluoride, vitamin a and vitamin d edetic acid glycerin polysorbate 80 potassium sorbate water sodium benzoate sorbitol sucralose vitamin a vitamin a ascorbic acid ascorbic acid vitamin d vitamin d sodium fluoride fluoride ion caramel color

Indications and Usage:

Indications and usage supplementation of the diet with vitamins a, c and d. tri-vite drops with fluoride 0.25 mg also provides fluoride for caries prophylaxis. the american academy of pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. the american academy of pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provided in a dose of 1 ml of tri-vite drops with fluoride 0.25 mg (see dosage and administration ). tri-vite drops with fluoride 0.25 mg supply significant amounts of vitamins a, c and d to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. thus, in a Read more...

single easy-to-use preparation, children obtain essential vitamins and fluoride.

Warnings:

Warnings as in the case of all medications, keep out of reach of children.

Dosage and Administration:

Dosage and administration 1.0 ml daily or as directed by physician. may be dropped directly into the mouth with dropper; or mixed with cereal, fruit juice or other food. tri-vite drops with fluoride 0.25 mg is available in 50 ml bottles with accompanying calibrated dropper.

Adverse Reactions:

Adverse reactions allergic rash and other idiosyncrasies have been rarely reported.

Clinical Pharmacology:

Clinical pharmacology it is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries. hydroxyapatite is the principal crystal for all calcified tissue in the human body. the fluoride ion reacts with hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. the reaction may be expressed by the equation: three stages of fluoride deposition in tooth enamel can be distinguished: 1. small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed. 2. after enamel has been laid down, fluoride deposition continues in the surface enamel. diffusion of fluoride from the surface inward is apparently restricted. 3. after eruption, the surface enamel acquires fluoride from water, food, supplementary fluoride and smaller amounts from saliva. equation

Package Label Principal Display Panel:

Principal display panel ndc 58657-323-50 tri-vite drops with fluroide 0.25 mg 1.69 fl. oz. (50 ml) ndc 58657-323-50 tri-vite drops with fluroide 0.25 mg 1.69 fl. oz. (50 ml)

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.