Multi-Vit With Fluoride 0.25 mg And Iron Drops®

Suggested/Recommended/Usage/Directions

MULTI-VIT with FLUORIDE 0.25 mg and IRON drops 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.)

Suggested/Recommended/Usage/Directions

DOSAGE AND ADMINISTRATION: 1 mL daily, or as prescribed. May be dropped directly into mouth with dropper, or mixed with fruit juice, cereal or other food.

Storage

After opening, store away from direct light.

Formula re: Contains

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

Formula re: Contains

WITH IRON

Formula re: Contains

3 Each 1 mL supplies sodium fluoride (0.25 mg fluoride) plus eight essential vitamins and iron. MULTI-VIT with FLUORIDE 0.25 mg and IRON drops supply significant amounts of vitamins A, C, D, E, thiamin, riboflavin, niacin, vitamin B6 and iron to supplement the diet, and to help assure that deficiencies of these nutrients will not develop. Thus, in a single easy-to-use preparation, infants and children obtain eight essential vitamins and iron, plus fluoride.

Formula re: Contains

Multi-Vit With Fluoride 0.25 mg And Iron Drops

FDA Statement of Identity

Multivitamin, Fluoride & Iron Supplement Drops

General Statements: All Other Content

Rx Only

General: Product/Version Code

Rev. 4/09 R8 8068030 1452

General Statements: All Other Content

N

General Statements: All Other Content

Occasional deepening of color has no significant effect on vitamin potency.

General Statements: All Other Content

REFERENCES 1. Brudevold F, McCann HG. Fluoride and caries control - Mechanism of action. In: Nizel AE, ed. The Science of Nutrition and Its Application in Clinical Dentistry. Philadelphia: WB Saunders Co.; 1966;331-347. 2. American Academy of Pediatrics, Committee on Nutrition: Fluoride Supplementation for Children: Interim Policy Recommendations. AAP News, February 1995, pg 18. 3. American Dental Association Council on Dental Therapeutics. New Fluoride Schedule Adopted. ADA News. May 16, 1994;12-14.

General Statements: All Other Content

While taking drops with iron, a slight darkening of the teeth may occur. Brushing will minimize this temporary condition.

General Statements: All Other Content

Your doctor or dentist is the best source of counsel and guidance in your child’s fluoride supplementation.

General Statements: All Other Content

Rev. 4/09 R9 8268032 1452

General Statements: All Other Content

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. Three stages of fluoride deposition in tooth enamel can be distinguished:1 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.

General Statements: All Other Content

INDICATIONS AND USAGE: Supplementation of the diet with eight essential vitamins and iron. Supplementation of the diet with fluoride for caries prophylaxis. MULTI-VIT with FLUORIDE 0.25 mg and IRON drops provide fluoride in drop form for infants and young children from 6 months to 3 years of age in areas where the drinking water contains less than 0.3 ppm of fluoride and for children ages 3 to 6 years in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride.2

General Statements: All Other Content

DISPENSE in original container.