TRI-VIT WITH FLUORIDE DROPS- ascorbic acid and cholecalciferol and sodium fluoride and vitamin a palmitate solution

Tri-Vit with Fluoride Drops by

Drug Labeling and Warnings

Tri-Vit with Fluoride Drops by is a Prescription medication manufactured, distributed, or labeled by Par Pharmaceutical. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Supplement Facts
Dosage Size 1 mL (Mark on Dropper)
Amount Per 1 mL	% Daily Value; Children Under; Age 4 Years
Vitamin A 1500 IU	60%
Vitamin C 35 mg	88%
Vitamin D 400 IU	100%
Fluoride 0.5 mg	*
*Daily Value (DV) not established

Active ingredient for caries prophylaxis: 
Each 1 mL contains 0.5 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

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:

Supplementation of the diet with vitamins A, D, and C. TRI-VIT with FLUORIDE 0.5 mg drops also provide fluoride for caries prophylaxis. TRI-VIT with FLUORIDE 0.5 mg (vitamins A, D, C and fluoride) drops provide fluoride in drop form for children ages 3 to 6 years in areas where the drinking water contains less than 0.3 ppm of fluoride and for children 6 years of age and older in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride.2 Each 1 mL supplies sodium fluoride (0.5 mg fluoride) plus three basic vitamins. TRI-VIT with FLUORIDE 0.5 mg drops supply significant amounts of vitamins A, D, and C 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, infants and children obtain three essential vitamins plus fluoride. A comprehensive 5 1/2 year series of studies of the effectiveness of vitamin-fluoride products in caries protection has been published.3-6 Children in this continuing study lived in an area where the water supply contained only 0.05 ppm fluoride. The subjects were divided into two groups, one which used only non-fluoridated vitamin products and other vitamin-fluoride products. The three-year interim report showed 63% fewer carious surfaces in primary teeth and 43% fewer carious surfaces in permanent teeth of the children taking vitamin-fluoride products.3
After four years the studies continued to support the effectiveness of vitamin-fluoride products, showing a reduction in carious surfaces of 68% in primary teeth and 46% in permanent teeth.4
Results at the end of 5 1/2 years further confirmed the previous findings and indicated that significant reductions in dental caries are apparent with the continued use of vitamin-fluoride products.5 

WARNING:

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 0.5 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 0.5 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 a 50-mL size is well below the maximum to be dispensed at one time according to recommendations of the American Dental Association.)

ADVERSE REACTIONS:

Allergic rash and other idiosyncrasies have been rarely reported. 

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. 

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.; 1996;331-347.
2. American Academy of Pediatrics, Committee on Nutrition: Fluoride Supplementation for Children: Interim Policy Recommendations. Pediatrics. 1995;95:777.
3. 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. January 1966;33:3-12.
4. 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. November 1967;34:439-443.
5. 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.
6. 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.

SPL UNCLASSIFIED SECTION

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

Rev. 3/15 R8
8277525   

PRINCIPAL DISPLAY PANEL - carton

PRINCIPAL DISPALY PANEL - label

INGREDIENTS AND APPEARANCE

TRI-VIT WITH FLUORIDE DROPS 
ascorbic acid and cholecalciferol and sodium fluoride and vitamin a palmitate solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0603-1786
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	1500 [iU]  in 1 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	35 mg  in 1 mL
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]  in 1 mL
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color	BROWN (Clear-Brown)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0603-1786-47	1 in 1 CARTON	04/01/1995	03/31/2021
1		50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		04/01/1995	03/31/2021

Labeler - Par Pharmaceutical (011103059)