NDC 58657-323 Tri-vite Drops With Fluoride

Ascorbic Acid, Sodium Fluoride, Vitamin A And Vitamin D

NDC Product Code 58657-323

NDC CODE: 58657-323

Proprietary Name: Tri-vite Drops 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: Ascorbic Acid, Sodium Fluoride, 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.

Product Characteristics

Color(s):
BROWN (C48332 - CARAMEL COLOR)
Flavor(s):
CHERRY (C73375)

NDC Code Structure

  • 58657 - Method Pharmaceuticals, Llc

NDC 58657-323-50

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 50 mL in 1 BOTTLE, DROPPER

Price per Unit: $0.21340 per ML

NDC Product Information

Tri-vite Drops With Fluoride with NDC 58657-323 is a a human prescription drug product labeled by Method Pharmaceuticals, Llc. The generic name of Tri-vite Drops With Fluoride is ascorbic acid, sodium fluoride, vitamin a and vitamin d. The product's dosage form is solution and is administered via oral form.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Tri-vite Drops 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.

  • EDETIC ACID (UNII: 9G34HU7RV0)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

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]

Product Labeler Information

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

Labeler Name: Method Pharmaceuticals, Llc
Labeler Code: 58657
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: 07-25-2018 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.

Tri-vite Drops 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. 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.

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

Warnings

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

Precautions

The suggested dose should not be exceeded since dental fluorosis may result from continued ingestion of large amounts of fluoride.When prescribing vitamin fluoride products:1. Determine the fluoride content of the drinking water.2. Make sure the child is not receiving significant amounts of fluoride from other medications and swallowed toothpaste. 3. Periodically check to make sure that the child does not develop significant dental fluorosis.Tri-Vite Drops with Fluoride 0.25 mg should be dispensed in the original plastic container, since contact with glass leads to instability and precipitation. (The amount of sodium fluoride in the 50 mL size is well below the maximum to be dispensed at one time according to recommendations of the American Dental Association.)Important Considerations When Using Dosage Schedule:• If fluoride level is unknown, drinking water should be tested for fluoride content before supplements are prescribed. For testing of fluoride content, contact the local or state health department.• All sources of fluoride should be evaluated with a thorough fluoride history. Patient exposure to multiple water sources can make proper prescribing complex.• Ingestion of higher than recommended levels of fluoride by children has been associated with an increase in mild dental fluorosis in developing, unerupted teeth.• Fluoride supplements require long-term compliance on a daily basis.

Adverse Reactions

Allergic rash and other idiosyncrasies have been rarely reported.

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.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). After opening, store away from direct light. Close tightly after each use. Occasional deepening of color has no significant effect on vitamin potency.REFRIGERATION IS NOT REQUIRED.


SHAKE WELL.

References

1. Brudevoid F, McCann HG: Fluoride and caries control - Mechanism of action, in Nizel AE (ed):


The Science of Nutrition and its Application in Clinical Dentistry. Philadelphia, WB Saunders Co, 1966, pp 331-347.


2. American Academy of Pediatrics Committee on Nutrition: Fluoride supplementation,


Pediatrics 1986; 77:758.


3. American Dental Association Council on Dental Therapeutics:


Accepted Dental Therapeutics, ed 38, Chicago, 1979, p321.


4. Hennon DK, Stookey GK, Muhler JC: The clinical anticariogenic effectiveness of supplementary fluoride-vitamin preparations - Results at the end of three years.


J Dent Children 1966; 33 January: 3-12.


5. Hennon DK, Stookey GK, Muhler JC: The clinical anticariogenic effectiveness of supplementary fluoride-vitamin preparations - Results at the end of four years.


J Dent Children 1967; 34 November; 439- 443.


6. Hennon DK, Stookey GK, Muhler JC: The clinical anticariogenic effectiveness of supplementary fluoride-vitamin preparations - Results at the end of five and a half years.


Phar and Ther in Dent 1970; 1:1.


7. Hennon DK, Stookey GK, Beiswanger BB: Fluoride-vitamin supplements: Effects on dental caries and fluorosis when used in areas with suboptimum fluoride in the water supply.


J Am Dent Assoc 1977; 95-965


Distributed by:Method Pharmaceuticals, LLC


Fort Worth, TX 76118


1-877-250-3427


Rev. 07/2018

* Please review the disclaimer below.