MultiVitamin Iron and Fluoridenone

Suggested/Recommended/Usage/Directions

Dosage and Administration Infants and children under 2 years of age: 1.0 mL daily or as recommended by a physician. May be dropped directly into the mouth with the enclosed dropper or mixed with cereal, fruit juice, or other food.

Storage

Recommended Storage Store at controlled room temperature, 20 degrees-25 degrees C (68 degrees-77 degrees F) [See USP Controlled Room Temperature]. After opening, store away from direct sunlight. Close tightly after each use. Refrigeration is not required.

Formulation re: Other

Clinical Pharmacology 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: Ca10(PO4)6(OH)2+2F- (Hydroxyapatite) -> Ca10(PO4)6F2+20H- (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 form the surface inward is apparently restricted. 3. After eruption, the surface enamel acquires fluoride from water, food, supplementary fluoride and small amounts from saliva.

Formula re: Contains

MultiVitamin, Iron and Fluoride Supplement Drops 0.25 mg provide supplementation of the diet with iron and eight essential vitamins, as well as sodium fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to the age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. MultiVitamin, Iron and Fluoride Supplemental Drops 0.25 mg provide fluoride in drop form for children 2 to 3 years of age, in areas 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 supplies sodium fluoride (0.25 mg fluoride) plus eight essential vitamins and iron. The American Academy of Pediatrics and the American Dental Association currently recommend that infants and young children under 2 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 2-3 years of age, in the areas where the drinking water contains 0.3 through 0.7 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provided in a full dose (1 mL) of MultiVitamin, Iron and Fluoride Supplemental Drops 0.25 mg. MultiVitamin, Iron and Fluoride Supplemental Drops 0.25 mg provide significant amounts of vitamins A, C, D, E, thiamine, riboflavin, niacinamide, pyridoxine and iron to supplement the diet, and to help ensure that nutritional deficiencies of these vitamins will not develop.

Formula re: Contains

Active ingredient for caries prophylaxis: Each 1 mL contains 0.25 mg fluoride as sodium fluoride.

FDA Disclaimer Statement

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

FDA Statement of Identity

Supplement Drops

General Statements: All Other Content

How Supplied MultiVitamin, Iron and Fluoride Supplemental Drops 0.25 mg are available in 50 mL bottles with accompanying calibrated dropper.

General Statements: All Other Content

Rx

General Statements: All Other Content

U.S. Recommended Daily Allowance not established.