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Side Effects & Adverse Reactions
As in the case of all medications, keep out of reach of children.
Legal Issues
There is currently no legal information available for this drug.
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There are currently no FDA labeling changes available for this drug.
Uses
Supplementation of the diet with Vitamins A, C, D and Fluoride 0.25 mg Drops 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. Vitamins A, C, D 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 children ages 2-3 years where the drinking water contains less than 0.3 ppm of fluoride and for children over 3 years, in areas where the drinking water contains 0.3 through 0.7 ppm of fluoride. Each 1.0 mL provides sodium fluoride (0.25 mg fluoride) plus eight essential vitamins and iron.
The American Academy of Pediatrics recommends that infants and young children under 6 months to 3 years of age, in areas where drinking water contains less than 0.3 ppm of fluoride, and; and for children ages 3-6 years, 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 Vitamins A, C, D and Fluoride.
Vitamins A, C, D and Fluoride 0.25 mg Drops provide significant amounts of vitamins A, D, E, C thiamine, riboflavin, niacin, pyridoxine, and iron 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 eight essential vitamins and iron, plus 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 in to two groups, one which used only the non-fluoride vitamin product, and the other multi-vitamins and fluoride drop 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.
Results at the end of the 5-1/2 years further confirmed the previous finds and indicated that significant reductions in dental caries are apparent with the continued use of multi-vitamin-fluoride products.
History
There is currently no drug history available for this drug.
Other Information
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Each 1.0 mL supplies: | Percentage of U.S. Recommended Daily Allowance | ||
Infants | Children Under 4 | ||
Vitamin A | 1500 IU | 100 | 60 |
Vitamin C (Ascorbic Acid) | 35 mg | 100 | 88 |
Vitamin D | 400 IU | 100 | 100 |
Fluoride | 0.25 mg | * | * |
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, ferrous sulfate, flavor, glycerin, methylparaben, niacinamide, polysorbate 80, purified water, sodium benzoate, sodium hydroxide, sucralose, vitamin A palmitate.
Sources
Vitamins A Manufacturers
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Libertas Pharma, Inc.
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