MULTI-VITAMIN WITH FLUORIDE- vitamin a, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, thiamine hydrochloride, riboflavin 5-phosphate sodium, cyanocobalamin, niacinamide, pyridoxine hydrochloride and sodium fluoride liquid
Method Pharmaceuticals, LLC
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.
Multi-Vitamin Drops with Fluoride 0.5 mg
|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
|Vitamin B1 (as Thiamine HCl)||0.5 mg||71%|
|Vitamin B2 (as Riboflavin Phosphate Sodium)
|Vitamin B12 (as Cyanocobalamin)||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||*|
*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. This product does not contain Folic Acid.
Other ingredients: Cherry Flavor, Citric Acid Anhydrous, Glycerin, Orange Flavor, Potassium Sorbate, Propylene Glycol, Purified Water, Sodium Benzoate, Sorbitol Solution, Sucralose.
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:
Three stages of fluoride deposition in tooth enamel can be distinguished:
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 0.5 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:
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)*|
|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.
Multi-Vitamin and Fluoride 0.5 mg drops is available in 50 mL bottles with accompanying calibrated dropper.
Store at controlled room temperature 15°-25°C (between 59°F and 77°F). 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.
Method Pharmaceuticals, LLC
Fort Worth, TX 76118
Made in the USA
|MULTI-VITAMIN WITH FLUORIDE
vitamin a, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, thiamine hydrochloride, riboflavin 5-phosphate sodium, cyanocobalamin, niacinamide, pyridoxine hydrochloride and sodium fluoride liquid
|Labeler - Method Pharmaceuticals, LLC (060216698)|