Multivitamin With Fluoride

.alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cyanocobalamin, Folic Acid, Niacin, Pyridoxine, Riboflavin, Sodium Fluoride, Thiamine Mononitrate, Vitamin A And Vitamin D

Method Pharmaceuticals, Llc
Human Prescription Drug
NDC 58657-164

Multivitamin With Fluoride also known as .alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cyanocobalamin, Folic Acid, Niacin, Pyridoxine, Riboflavin, Sodium Fluoride, Thiamine Mononitrate, Vitamin A And Vitamin D is a human prescription drug labeled by 'Method Pharmaceuticals, Llc'. National Drug Code (NDC) number for Multivitamin With Fluoride is 58657-164. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Multivitamin With Fluoride drug includes .alpha.-tocopherol Acetate, Dl- - 15 [iU]/1 Ascorbic Acid - 60 mg/1 Cyanocobalamin - 4.5 ug/1 Folic Acid - 300 ug/1 Niacin - 13.5 mg/1 Pyridoxine - 1.05 mg/1 Riboflavin - 1.2 mg/1 Sodium Fluoride - .5 mg/1 Thiamine Mononitrate - 1.05 mg/1 Vitamin A - 2500 [iU]/1 and more. The currest status of Multivitamin With Fluoride drug is Active.

Drug Information:

Drug NDC:	58657-164
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:	Multivitamin 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:	.alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cyanocobalamin, Folic Acid, Niacin, Pyridoxine, Riboflavin, Sodium Fluoride, Thiamine Mononitrate, 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:	Tablet, Chewable
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:	.ALPHA.-TOCOPHEROL ACETATE, DL- - 15 [iU]/1 ASCORBIC ACID - 60 mg/1 CYANOCOBALAMIN - 4.5 ug/1 FOLIC ACID - 300 ug/1 NIACIN - 13.5 mg/1 PYRIDOXINE - 1.05 mg/1 RIBOFLAVIN - 1.2 mg/1 SODIUM FLUORIDE - .5 mg/1 THIAMINE MONONITRATE - 1.05 mg/1 VITAMIN A - 2500 [iU]/1 Load more... VITAMIN D - 400 [iU]/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 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:	20 Jul, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	20 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.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000193618 M0001797 M0022794 N0000175951 N0000175594 M0014839 N0000192800 N0000005657 N0000175452 M0022788 N0000175950
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	WR1WPI7EW8 PQ6CK8PD0R P6YC3EG204 935E97BOY8 2679MF687A KV2JZ1BI6Z TLM2976OFR 8ZYQ1474W7 8K0I04919X 81G40H8B0T Load more... 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 B12 [EPC] Nicotinic Acid [EPC] Vitamin B6 Analog [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 B 12 [CS] Nicotinic Acids [CS] Vitamin B 6 [Chemical/Ingredient] Analogs/Derivatives [Chemical/Ingredient] 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:	Analogs/Derivatives [Chemical/Ingredient] Ascorbic Acid [CS] Nicotinic Acid [EPC] Nicotinic Acids [CS] Vitamin A [CS] Vitamin A [EPC] Vitamin B 12 [CS] Vitamin B 6 [Chemical/Ingredient] Vitamin B12 [EPC] Vitamin B6 Analog [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
58657-164-01	100 TABLET, CHEWABLE in 1 BOTTLE (58657-164-01)	20 Jul, 2018	N/A	No
58657-164-90	90 TABLET, CHEWABLE in 1 BOTTLE (58657-164-90)	20 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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Product Elements:

Multivitamin with fluoride .alpha.-tocopherol acetate, dl-, ascorbic acid, cyanocobalamin, folic acid, niacin, pyridoxine, riboflavin, sodium fluoride, thiamine mononitrate, vitamin a and vitamin d citric acid monohydrate magnesium stearate mannitol cellulose, microcrystalline sucralose talc xylitol vitamin a vitamin a ascorbic acid ascorbic acid vitamin d vitamin d .alpha.-tocopherol acetate, dl- .alpha.-tocopherol, dl- thiamine mononitrate thiamine ion thiamine riboflavin riboflavin niacin niacin pyridoxine pyridoxine folic acid folic acid cyanocobalamin cyanocobalamin sodium fluoride fluoride ion yellowish/cream m164

Indications and Usage:

Indications and usage supplementation of the diet with ten essential vitamins. supplementation of the diet with fluoride for caries prophylaxis. m ultivitamin with fluoride 0.5 mg chewable tablets provide 0.5 mg fluoride in tablet form for children 4-6 years of age in areas where the drinking water fluoride level is less than 0.3 ppm, and for children 6 years of age and above where the drinking water contains 0.3 through 0.6 ppm of fluoride. multivitamin with fluoride 0.5 mg chewable tablets supply significant amounts of vitamins a, c, d, e, thiamine, riboflavin, niacin, vitamin b6, vitamin b12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride. 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 Read more...

daily fluoride supplements. children using multivitamin with fluoride 0 . 5 mg chewable tablets regularly should receive semiannual dental examinations. the regular brushing of teeth and attention to good oral hygiene practices are also essential. multivitamin with fluoride chewable tablets is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.

Warnings:

Warning keep out of the reach of children. in case of accidental overdose, seek professional assistance or contact a poison control center immediately. caution do not eat or drink dairy products within one hour of fluoride administration. should be chewed. this product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.

Dosage and Administration:

Dosage and administration one tablet daily, to be dissolved in the mouth or chewed before swallowing. do not give a chewable tablet to a child younger than 4 years old.

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. multivitamin with fluoride 0 . 5 mg chewable tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. because the tablets are chewable, they provide a topical as well as systemic source of fluoride. hydroxyapatite is the principal crystal for all calcified tissue in the human body. the fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite . the reaction may be expressed by the equation: ca10(po4)6(oh)2 + 2f- ------- ca10(po4)6f2 + 2oh- (hydroxyapatite) (fluorapatite) 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 Read more...

. 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 the water, food, supplementary fluoride and smaller amounts from saliva.

How Supplied:

How supplied multivitamin chewable tablets containing 0.5 mg fluoride are round yellowish/cream tablets with orange and yellow speckles. debossed with âm164â on one side. ndc: 58657-164-90 (90 count) ndc: 58657-164-01 (100 count)

Package Label Principal Display Panel:

Principal display panel ndc 58657-164-90 multivitamin with fluoride chewable tablets 0.5 mg orange flavor rx only 90 tablets ndc 58657-164-90 multivitamin with fluoride chewable tablets 0.5 mg orange flavor rx only 90 tablets

Principal display panel ndc 58657-164-01 multivitamin with fluoride chewable tablets 0.5 mg orange flavor rx only 100 tablets multivitamin with fluoride chewable tablets 0.5 mg orange flavor rx only 100 tablets

Comments/ Reviews:

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