NDC 63629-1134 Multivitamin With Fluoride

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

NDC Product Code 63629-1134

NDC CODE: 63629-1134

Proprietary Name: Multivitamin With Fluoride What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: .alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cyanocobalamin, Folic Acid, Niacin, Pyridoxine, Riboflavin, Sodium Fluoride, Thiamine Mononitrate, Vitamin A And Vitamin D What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is a combination product of vitamins and fluoride. It is used in children to treat or prevent deficiency due to poor diet or low levels of fluoride in drinking water and other sources. Vitamins are important building blocks of the body and help keep you in good health. Fluoride is used to prevent dental cavities.

Product Characteristics

Color(s):
YELLOW (C48330 - YELLOWISH/CREAM)
Shape: ROUND (C48348)
Size(s):
9 MM
Imprint(s):
M163
Score: 1
Flavor(s):
ORANGE (C73406)

NDC Code Structure

  • 63629 - Bryant Ranch Prepack

NDC 63629-1134-1

Package Description: 100 TABLET, CHEWABLE in 1 BOTTLE

NDC Product Information

Multivitamin With Fluoride with NDC 63629-1134 is a a human prescription drug product labeled by Bryant Ranch Prepack. The generic name of Multivitamin With Fluoride is .alpha.-tocopherol acetate, dl-, ascorbic acid, cyanocobalamin, folic acid, niacin, pyridoxine, riboflavin, sodium fluoride, thiamine mononitrate, vitamin a and vitamin d. The product's dosage form is tablet, chewable and is administered via oral form.

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Multivitamin With Fluoride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MANNITOL (UNII: 3OWL53L36A)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • TALC (UNII: 7SEV7J4R1U)
  • XYLITOL (UNII: VCQ006KQ1E)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Vitamin A - [CS]
  • Vitamin A - [EPC] (Established Pharmacologic Class)
  • Vitamin C - [EPC] (Established Pharmacologic Class)
  • Ascorbic Acid - [CS]
  • Nicotinic Acid - [EPC] (Established Pharmacologic Class)
  • Nicotinic Acids - [CS]
  • Vitamin B6 Analog - [EPC] (Established Pharmacologic Class)
  • Vitamin B 6 - [Chemical/Ingredient]
  • Analogs/Derivatives - [Chemical/Ingredient]
  • Vitamin B 12 - [CS]
  • Vitamin B12 - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bryant Ranch Prepack
Labeler Code: 63629
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 07-20-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Multivitamin With Fluoride Product Label Images

Multivitamin With Fluoride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 0.25 mg Chewable Tabletsprovide 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. 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.

Indications And Usage

Supplementation of the diet with ten essential vitamins.Supplementation of the diet with fluoride for caries prophylaxis.Multivitamin with Fluoride 0.25 mg Chewable Tablets provide 0.25 mg fluoride in tablet form for children 4-6years of age in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride.Multivitamin with Fluoride 0.25 mg Chewable Tabletssupply 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 daily fluoride supplements.Children using Multivitamin with Fluoride 0.25 mgChewable 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.

Warning

Keep out of the reach of children. In case of accidentaloverdose, seek professional assistance or contact aPoison Control Center immediately.CAUTIONDo 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.

Precaution

The suggested dose of Multivitamin with Fluoride 0.25 mgChewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride. Before prescribing Multivitamin with Fluoride 0.25 mgChewable Tablets:1. Determine the fluoride content of the drinking water from all major sources.2. Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste.3. Periodically check to make sure that the child does not develop significant dental fluorosis.

Adverse Reactions

Allergic rash and other idiosyncrasies have been rarely reported.

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.

How Supplied

NDC: 63629-1134-1 100 Chewable Tablets in a BOTTLE

Storage

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.Dispense in a tight, light resistant container with a child-resistant closure as defined in the USP/NF. All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.Manufactured For:Method PharmaceuticalsFort Worth, TX 76118Rev. 06/2019

* Please review the disclaimer below.