Multi Vitamin and Fluoride

Libertas Pharma, Inc.

Multi Vitamin and Fluoride Supplemental Drops 0.25 mg Drops

FULL PRESCRIBING INFORMATION: CONTENTS*

• MULTI VITAMIN AND FLUORIDE DESCRIPTION
• CLINICAL PHARMACOLOGY
• MULTI VITAMIN AND FLUORIDE INDICATIONS AND USAGE
• WARNINGS
• PRECAUTIONS
• MULTI VITAMIN AND FLUORIDE ADVERSE REACTIONS
• MULTI VITAMIN AND FLUORIDE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
  • RECOMMENDED STORAGE:
• Container Label

FULL PRESCRIBING INFORMATION

MULTI VITAMIN AND FLUORIDE DESCRIPTION

Each 1.0 mL supplies:		Percentage of U.S. Recommended Daily Allowance
		Infants	Children Under 4
Vitamin A	1500 IU	100	60
Vitamin C	35 mg	100	88
Vitamin D	400 IU	100	100
Vitamin E	5 IU	100	50
Thiamine	0.5 mg	100	71
Riboflavin	0.6 mg	100	75
Niacin	8 mg	100	89
Vitamin B6	0.4 mg	100	57
Vitamin B12	2 mcg	100	67
Fluoride	0.25 mg	U.S. RDA not established	U.S. RDA not established

This product does not contain the essential vitamin folic acid.

See INDICATIONS AND USAGE section below for use by infants and young children 6 months to 3 years of age.

Active ingredient for caries prophylaxis: Fluoride as sodium fluoride.

Other Ingredients: Ascorbic acid, caramel color, cholecalciferol, citric acid, cyanocobalamin, D-alpha tocopheryl acid succinate, ferrous sulfate, flavor, glycerin, methylparaben, niacinamide, polysorbate 80, purified water, pyridoxine HCL, riboflavin-5-phosphate sodium, sodium benzoate, sodium hydroxide, sucralose, thiamine HCL, vitamin A palmitate.

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:

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

• Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.
• After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.
• After eruption, the surface enamel acquires fluoride from water, food, supplementary fluoride and smaller amounts from saliva.

MULTI VITAMIN AND FLUORIDE INDICATIONS AND USAGE

Supplementation of the diet with nine essential vitamins.

Supplementation of the diet with 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. Multivitamin and Fluoride Supplemental Drops 0.25 mg provide fluoride in drop form for 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 for children ages 3-6 years, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride. Each 1.0 mL supplies sodium fluoride (0.25 mg fluoride) plus nine essential vitamins.

The American Academy of Pediatrics recommended 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 full dose (1mL) of Multi Vitamin and Fluoride Supplemental Drops 0.25 mg. A half dose (0.5mL) of Multi Vitamin and Fluoride Supplemental Drops 0.5 mg could also provide a daily fluoride intake of 0.25mg; however, the dosage reduces vitamin supplementation by half.

Multi Vitamin and Fluoride Supplemental Drops 0.25 mg and Multi Vitamin and Fluoride Supplemental Drops 0.5 mg drops supply significant amounts of vitamins A, C, D, E, thiamine, riboflavin, niacin, pyridoxine, and cyanocobalamin 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, infants and children obtain nine essential vitamins and fluoride.

A comprehensive 5-1/2 year series of studies of the effectiveness of multivitamin, iron, and fluoride drops in caries protection has been published. Children in this continuing study lived in an area where the water supply contained only 0.05 ppm fluoride. The subjects were divided into 2 groups, one which used only the non-fluoride vitamin product, and the other, multi-vitamins-fluoride products. Children in this continuing study lived in an area where the water supply contained only 0.05 ppm fluoride. The subjects were divided into 2 groups, one which used only non-fluoridated vitamin product and the other, multi-vitamins-fluoride products.

The three-year interim report showed 63% fewer carious surfaces in primary teeth and 43% fewer carious surfaces in permanent teeth of the children taking multi-vitamin-fluoride products.

After four years, the studies continued to support the effectiveness of multi-vitamin-fluoride products, showing a reduction in carious surfaces of 68% in primary teeth and 46% in permanent teeth.

Results at the end of the 51/2 years further confirmed the previous findings and indicated that significant reductions in dental caries are apparent with the continued use of multi-vitamin-fluoride products.

WARNINGS

As in the case of all medications, keep out of reach of children.

PRECAUTIONS

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:

• Determine the fluoride content of the drinking water.
• Make sure the child is not receiving significant amounts of fluoride from other medications and swallowed toothpaste.
• Periodically check to make sure that the child does not develop significant dental fluorosis.
• Multi Vitamin and Fluoride Supplemental Drops 0.25 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.)

MULTI VITAMIN AND FLUORIDE ADVERSE REACTIONS

Allergic rash and other idiosyncrasies have been rarely reported.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

MULTI VITAMIN AND FLUORIDE DOSAGE AND ADMINISTRATION

1.0 mL daily or as prescribed by physician. May be dropped directly into mouth with dropper; or mixed with cereal, fruit juice or other food.

HOW SUPPLIED

Multivitamin and Fluoride Supplemental Drops 0.25 mg are available in 50 mL bottles with accompanying calibrated dropper, NDC 51862-161-50.

RECOMMENDED STORAGE:

Store at controlled room temperature, 20º-25ºC (68º-77ºF). [See USP Controlled Room Temperature]. After opening, store away from direct light. Close tightly after each use. REFRIGERATION IS NOT REQUIRED.

Manufactured for:
Libertas Pharma, Inc.
Lawrenceville, GA 30043

Iss. 03/11 161-50         743623

Container Label

NDC 51862-161-50

Rx Only

Multi-Vitamin

and Fluoride

Supplemental Drops

0.25 mg Drops

1 ^2/3 fl. oz. (50 mL)

Libertas

Pharma Inc.