Multi Vitamin and Fluoride

MULTI VITAMIN AND FLUORIDE- vitamin a palmitate, ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine hydrochloride, riboflavin 5′-phosphate sodium, niacinamide, pyridoxine hydrochloride, cyanocobalamin and sodium fluoride solution/ drops
Libertas Pharma, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

DESCRIPTION

*
U.S. RDA not established
Each 1.0 mL supplies: Percentage of U.S. Recommended Daily Allowance
Infants Children Under 4
Vitamin A 1500 IU 100 60
Vitamin C 35 mg 100 88
Vitamin D 400 IU 100 100
Vitamin E 5 IU 100 50
Thiamine 0.5 mg 100 71
Riboflavin 0.6 mg 100 75
Niacin 8 mg 100 89
Vitamin B6 0.4 mg 100 57
Vitamin B12 2 mcg 100 67
Fluoride 0.25 mg * *

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, cholecalciferol, citric acid, cyanocobalamin, D-alpha tocopheryl acid succinate, ferrous sulfate, flavor, glycerin, methylparaben, niacinamide, polysorbate 80, purified water, pyridoxine HCL, riboflavin-5-phosphate sodium, sodium benzoate, sodium hydroxide, sucralose, thiamine HCL, 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. The reaction may be expressed by the equation:

Reaction Equation
(click image for full-size original)

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.
Reaction Equation

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 Supplemental Drops 0.25 mg 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 Pediatrics recommended 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, 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 full dose (1mL) of Multi Vitamin and Fluoride Supplemental Drops 0.25 mg. A half dose (0.5mL) of Multi Vitamin and Fluoride Supplemental Drops 0.5 mg could also provide a daily fluoride intake of 0.25mg; however, the dosage reduces vitamin supplementation by half.

Multi Vitamin and Fluoride Supplemental Drops 0.25 mg and Multi Vitamin and Fluoride Supplemental Drops 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 deficiencies 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 multivitamin, iron, and fluoride drops in caries protection has been published. Children in this continuing study lived in an area where the water supply contained only 0.05 ppm fluoride. The subjects were divided into 2 groups, one which used only the non-fluoride vitamin product, and the other, multi-vitamins-fluoride products. Children in this continuing study lived in an area where the water supply contained only 0.05 ppm fluoride. The subjects were divided into 2 groups, one which used only non-fluoridated vitamin product and the other, multi-vitamins-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 multi-vitamin-fluoride products.

After four years, the studies continued to support the effectiveness of multi-vitamin-fluoride products, showing a reduction in carious surfaces of 68% in primary teeth and 46% in permanent teeth.

Results at the end of the 51/2 years further confirmed the previous findings and indicated that significant reductions in dental caries are apparent with the continued use of multi-vitamin-fluoride products.

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