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Tri-Vit with Fluoride: Package Insert / Prescribing Info

Package insert / product label
Generic name: ascorbic acid and cholecalciferol and sodium fluoride and vitamin a palmitate
Dosage form: oral solution
Drug class: Vitamin and mineral combinations

Tri-Vit with Fluoride Description

Supplement Facts
Dosage Size 1 mL (Mark on Dropper)
Amount Per
1 mL
% Daily Value
InfantsChildren Under
Age 4 Years
Vitamin A 1500 IU 100% 60%
Vitamin C 35 mg 100% 88%
Vitamin D 400 IU 100% 100%
Fluoride 0.25 mg * *
*Daily Value (DV) not established

Active ingredient for caries prophylaxis:
Each 1 mL contains 0.25 mg fluoride as sodium fluoride.

Other ingredients:

ascorbic acid (Vitamin C), caramel color, cholecalciferol (Vitamin D3), flavor, glycerin, polysorbate 80, purified water, sodium hydroxide, vitamin A palmitate.

Tri-Vit with Fluoride - 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 the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. Three stages of fluoride deposition in tooth enamel can be distinguished:1 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 for Tri-Vit with Fluoride

TRI-VIT with FLUORIDE 0.25 mg drops may be useful for infants whose diets are lacking in vitamins A, D and C. TRI-VIT with FLUORIDE 0.25 mg drops also provide fluoride for caries prophylaxis. TRI-VIT with FLUORIDE 0.25 mg (vitamins A, D, C, and fluoride) drops were developed to provide fluoride in drop form for infants and young children from 6 months to 3 years of age in areas where the drinking water contains less than 0.3 ppm of fluoride and for children ages 3 to 6 years in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride.2,3 Each 1 mL supplies sodium fluoride (0.25 mg fluoride) plus three basic vitamins.

Warnings

As with all medicines, keep out of the 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 TRI-VIT with FLUORIDE 0.25 mg drops: 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.
TRI-VIT with FLUORIDE 0.25 mg drops 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.)

Adverse Reactions/Side Effects

Allergic rash and other idiosyncrasies have been rarely reported.

Tri-Vit with Fluoride Dosage and Administration

1 mL daily, or as prescribed. May be dropped directly into mouth with dropper, or mixed with fruit juice, cereal or other food. USE FULL DOSAGE.

DISPENSE in original container

Storage and Handling

Occasional deepening of color has no significant effect on vitamin potency.

After opening, store away from direct light.

Your doctor or dentist is the best source of counsel and guidance in your child’s fluoride supplementation.

References

  1. Brudevold 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;331-347.
  2. American Academy of Pediatrics, Committee on Nutrition: Fluoride Supplementation for Children: Interim Policy Recommendations. Pediatrics. 1995;95(5):777.
  3. American Dental Association Council on Dental Therapeutics. New Fluoride Schedule Adopted. ADA News. May 16, 1994;12-14.

Manufactured for:
QUALITEST PHARMACEUTICALS
130 VINTAGE DRIVE
HUNTSVILLE, AL 35811

Rev. 3/15 R6
8277530

PRINCIPAL DISPLAY PANEL - carton

This is an image of the carton for Tri-Vit with Fluoride 0.25 mg Drops 50 mL.

PRINCIPAL DISPLAY PANEL - label

This is an image of the label for Tri-Vit with Fluoride 0.25 mg Drops 50 mL.
TRI-VIT WITH FLUORIDE DROPS
ascorbic acid and cholecalciferol and sodium fluoride and vitamin a palmitate solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0603-1785
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A1500 [iU] in 1 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID35 mg in 1 mL
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU] in 1 mL
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.25 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
Product Characteristics
ColorBROWN (Clear-Brown) Score
ShapeSize
FlavorCHERRYImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-1785-471 in 1 CARTON04/01/199502/28/2021
150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER04/01/199502/28/2021
Labeler - Par Pharmaceutical (011103059)