POLY-VITAMIN WITH FLUORIDE – vitamin a palmitate, ascorbic acid, cholecalciferol, .alpha.-tocopherol succinate, d-, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin and sodium fluoride solution/ drops 
Hi-Tech Pharmacal Co., Inc.

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DESCRIPTION

This product does not contain the essential vitamin folic acid.

See INDICATIONS AND USAGE section below for use by infants and young children 6 months to 3 years of age.

Active ingredient for caries prophylaxis: Fluoride as sodium fluoride.

Other Ingredients: Ascorbic acid, caramel color, cherry flavor, cholecalciferol, cyanocobalamin, ferrous sulfate, glycerin, methylparaben, niacinamide, oil of orange, polysorbate 80, purified water, pyridoxine hydrochloride, riboflavin-5-phosphate sodium, sodium benzoate, sodium hydroxide, thiamine hydrochloride, d-alpha tocopheryl acid succinate, vitamin A palmitate. Citric acid may be added to adjust pH.

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. The reaction may be expressed by the equation:1

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 nine essential vitamins.

Supplementation of the diet with 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.

Multivitamin and Fluoride 0.25 mg drops provide fluoride in drop form for 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 for children ages 3-6 years, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride. Each 1.0 mL supplies sodium fluoride (0.25 mg fluoride) plus nine essential vitamins.

The American Academy of Pediatrics2 and the American Dental Association3 currently recommend that infants and young children 6 months to 3 years of age, in areas where drinking water contains less than 0.3 ppm of fluoride, and children 3-6, 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 full dose (1 mL) of Multivitamin and Fluoride 0.25 mg drops. A half dose (0.5 mL) of Multivitamin and Fluoride Drops 0.5 mg drops could also provide a daily fluoride intake of 0.25 mg; however, this dosage reduces vitamin supplementation by half.

Multivitamin and Fluoride 0.25 mg and 0.5 mg drops supply significant amounts of vitamins A, C, D, E, thiamine, riboflavin, niacin, pyridoxine, and cyanocobalamin to supplement the diet, and to help assure that nutritional deficiences of these vitamins will not develop. Thus, in a single easy-to-use preparation, infants and children obtain nine essential vitamins and fluoride.

A comprehensive 5-1/2 year series of studies of the effectiveness of Tri-Vi-Flor® and Poly-Vi-Flor® products in caries protection has been published.4-7 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 Vi-Sol® vitamin products and the other Tri-Vi-Flor® and Poly-Vi-Flor® 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 Vi-Flor® vitamin-fluoride products.4

After four years the studies continued to support the effectiveness of Tri-Vi-Flor® and Poly-Vi-Flor®, showing a reduction in carious surfaces of 68% in primary teeth and 46% in permanent teeth.5 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 Vi-Flor® vitamin-fluoride products.6

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.

Multivitamin and Fluoride Drops 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.)

ADVERSE REACTIONS

Allergic rash and other idiosyncrasies have been rarely reported.

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010.

DOSAGE AND ADMINISTRATION

1.0 mL daily or as prescribed by physician. May be dropped directly into mouth with dropper; or mixed with cereal, fruit juice or other food.

HOW SUPPLIED

Multivitamin and Fluoride 0.25 mg drops are available in 50 mL bottles with accompanying calibrated dropper.

RECOMMENDED STORAGE:

Store at controlled room temperature, 15º-30ºC (59º-86ºF). 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

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, p 321.
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.

Manufactured By:

HI-TECH PHARMACAL CO., INC.

Amityville, N.Y. 11701

Rev. 642:06 4/09

PRINCIPAL DISPLAY PANEL

NDC 50383-642-50

Poly-Vitamin Drops

WITH FLUORIDE

0.25 mg

MULTIVITAMIN AND FLUORIDE SUPPLEMENT DROPS

Rx Only

1 2/3 FL. OZ. (50 mL)