FDA records indicate that there are no current recalls for this drug.
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Multi-vitamin Fluoride Recall
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Questions & Answers
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.
FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
DESCRIPTION | Percentage of U.S. Recommended Daily Allowance | |
---|---|---|
Each 1.0 mL supplies: | 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) | 0.5 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.
Sources
Multi-vitamin Fluoride Manufacturers
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Stratus Pharmaceuticals
Multi-vitamin Fluoride | Stratus Pharmaceuticals
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)* Age <0.3 ppm 0.3 - 0.6 ppm >0.6 ppm * 1.0 ppm = 1 mg/liter † 2.2 mg sodium fluoride contains 1 mg fluoride ion. 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
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