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Generic name: Vitamin A, Vitamin C, Vitamin D, Vitamin E, Vitamin B1, Vitamin B2, Vitamin B12, Niacin, Vitamin B6, Flouride
H.J. Harkins Company, Inc.
Dosage Form
N/A
Manufacturer
H.J. Harkins Company, Inc.
This medication contains important usage instructions, warnings, and side effect information that you should review before use.
Supplementation of the diet with vitamins A, C and D.
Multi-Vitamin Fluoride Drops 0.25 mg also provide 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 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 Fluoride 0.25 mg drops. (see Dosage and Administration).
Multi-Vitamin Fluoride 0.25 mg drops 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.
See following chart. May be dropped directly into mouth with dropper; or mixed with cereal, fruit juice or other food.
| Fluoride Ion Level in Drinking Water (ppm)* | |||
| 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 |
| *1.0 ppm = 1 mg/liter | |||
| ** 2.2 mg sodium fluoride contains 1 mg fluoride ion. |
Allergic rash and other idiosyncrasies have been rarely reported.
| Each 1.0 mL supplies: | Percentage of U.S. Recommended Daily Allowance Children 6 mos to 4 years old | |
| 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) | 0.25 mg | * |
| * Daily Value not established | ||
| 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, oil of orange, glycerin, methylparaben, polysorbate 80, purified water, sodium benzoate and sodium hydroxide.
[Rev 7]
Multi-Vitamin and Fluoride 0.25 mg drops is available in 50 mL bottles with accompanying calibrated dropper.
Photos of the product and/or packaging supplied by the manufacturer.
MULTI-VITAMIN FLUORIDE DROPS
0.25 mg per mL
Rx Only
It is well established that fluoridation of 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
Ca10(PO4)6(OH)2 + 2F- CA10(PO4)6F2 + 2OH-
(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.
Store at controlled room temperature, 15º-25ºC (59º-77ºF). Excursions permitted. 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
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