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VITAMINS A, C, D AND FLUORIDE
vitamin a palmitate,
sodium fluoride solution/ drops
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----------VITAMINS A, C, D AND FLUORIDE 0.25 Mg Drops
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.
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:
Three stages of fluoride deposition in tooth enamel can be distinguished:
INDICATIONS AND USAGE
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.
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:
Allergic rash and other idiosyncrasies have been rarely reported.
To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DOSAGE AND ADMINISTRATION
1.0 mL daily or as prescribed by physician. May be dropped directly into mouth with the enclosed dropper or mixed with cereal, fruit juice or other food.
Vitamins A, C, D and Fluoride 0.25 mg Drops are available in 50 mL bottles with accompanying calibrated dropper, NDC 51862-164-50.
Store at controlled room temperature, 20º-25ºC (68º-77ºF). [See USP Controlled Room Temperature]. After opening, store away from direct light. Close tightly after each use. REFRIGERATION IS NOT REQUIRED.
TAMPER EVIDENT: Do not use if printed bottle seal around bottle cap is broken or missing.
Iss. 03/11 164-50 743629
VITAMINS A, C, D
0.25 mg Drops
1 2/3 fl. oz. (50 mL)
Revised: 05/2011 Libertas Pharma, Inc.
Reproduced with permission of U.S. National Library of Medicine
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