MULTI-VITAMIN FLUORIDE- vitamin a, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, thiamine hydrochloride, riboflavin 5-phosphate sodium, niacinamide, pyridoxine hydrochloride, cyanocobalamin, and sodium fluoride liquid
Stratus Pharmaceuticals
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.
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DESCRIPTION | Percentage of U.S. Recommended Daily Allowance | |
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Each 1.0 mL supplies: | Children 6 mos to 4 Years old | |
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Vitamin A (as Vitamin A Palmitate) | 1500 IU | 60% |
Vitamin C (as Ascorbic Acid) | 35 mg | 88% |
Vitamin D (as Cholecalciferol) | 400 IU | 100% |
Vitamin E (as D-Alpha-Tocopheryl Acid Succinate) | 5 IU | 50% |
Vitamin B1 (as Thiamine HCl) | 0.5 mg | 71% |
Vitamin B2 (as Riboflavin Phosphate Sodium) | 0.6 mg | 75% |
Vitamin B12 (as Cyanocobalamine) | 2 mcg | 67% |
Niacin (as Niacinamide) | 8 mg | 89% |
Vitamin B6 (as Pyridoxine HCl) | 0.4 mg | 57% |
Fluoride (as Sodium Fluoride) | 0.5 mg | * |
See INDICATIONS AND USAGE section for use by children 6 months to 6 years of age.
This product does not contain the essential vitamin folic acid.
Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Does not contain folic acid.
Other ingredients: Caramel color, cherry flavor, ferrous sulfate, glycerin, methylparaben, oil of orange, polysorbate 80, purified water, sodium benzoate and sodium hydroxide.
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 hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite.
The reaction may be expressed by the equation:
Ca10(PO4)6(OH)2 + 2F- Ca10(PO4)6F2 + 20H- (Hydroxyapatite) (Fluorapatite) |
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.
Supplementation of the diet with vitamins A, C and D.
Multi-Vitamin Drops with Fluoride 0.5 mg 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.
The American Academy of Pediatrics recommend that 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 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 dose of 1 mL of Multi-Vitamin Drops with Fluoride 0.5 mg (See Dosage and Administration).
Multi-Vitamin Drops with Fluoride 0.5 mg supply significant amounts of vitamins A, C and D 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 essential vitamins and fluoride.
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.
Multi-Vitamin Drops with Fluoride 0.5 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.)
Important Considerations When Using Dosage Schedule:
See following chart. May be dropped directly into the mouth with dropper; or mixed with cereal, fruit juice or other food.
Fluoride Ion Level in Drinking Water (ppm)* | |||
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Age | <0.3 ppm | 0.3 - 0.6 ppm | >0.6 ppm |
Birth - 6 months | None | None | None |
6 mos - 3 years | 0.25 mg (1 mL) / day† | None | None |
3 - 6 years | 0.50 mg (2 mL) / day | 0.25 mg (1 mL) / day | None |
Multi-Vitamin Drops with Fluoride 0.5 mg is available in 50 mL bottles with accompanying calibrated dropper.
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). 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.
SHAKE WELL.
MULTI-VITAMIN FLUORIDE
vitamin a, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, thiamine hydrochloride, riboflavin 5-phosphate sodium, niacinamide, pyridoxine hydrochloride, cyanocobalamin, and sodium fluoride liquid |
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Labeler - Stratus Pharmaceuticals (789001641) |