Active ingredient for caries prophylaxis: Fluoride as Sodium Fluoride.

Inactive ingredients: Artificial cherry flavor, artificial grape flavor, ascorbic acid, aspartame, cholecalciferol, compressible sugar, D&C Red #7 calcium lake, FD&C Blue #1 aluminum lake, FD&C Yellow #6 aluminum lake, folic acid, magnesium stearate, microcrystalline cellulose, natural and artificial orange flavor, niacinamide, polyethylene glycol, pyridoxine HCL, riboflavin, sodium ascorbate, stearic acid, thiamine HCL, vitamin A acetate, vitamin B 12 and vitamin E acetate.

CLINICAL PHARMACOLOGY:

Significant decrease in the incidence of dental caries can be linked to the fluoridation of the water supply (1ppm fluoride) during the period of tooth development.

Multi-Vitamin with Fluoride Chewable Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride.

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-  —————> Ca10(PO4)6F2 + 2OH-

(Hydroxyapatite)                                   (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 from the surface inward is apparently restricted.

3. After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts from saliva.

INDICATIONS AND USAGE:

Supplementation of the diet with ten essential vitamins.

Supplementation of the diet with fluoride for caries prophylaxis.

Multi-Vitamin with Fluoride Chewable Tablets 1.0 mg provide fluoride in tablet form for children 6-16 years of age in areas where the water fluoride level is less than 0.3 ppm.

Multi-Vitamin with Fluoride Chewable Tablets 0.5 mg provide fluoride in tablet form for children 4-6 years of age in areas where the water fluoride level is less than 0.3 ppm, and for children 6 years of age and above where the drinking water contains 0.3 through 0.6 ppm if fluoride.

Multi-Vitamin with Fluoride Chewable Tablets 0.25 mg provide fluoride in tablet form for children 4-6 years of age where the drinking water contains 0.3 through 0.6 ppm of fluoride.

Multi-Vitamin with Fluoride Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B 12, and folate 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 ten essential vitamins and the important mineral, fluoride.

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.

Children using Multi Vitamin with Fluoride Chewable Tablets should regularly receive semi-annual dental examinations. Teeth brushing and good oral hygiene practices are essential as well.

WARNINGS:

AS IN THE CASE OF ALL MEDICATIONS, KEEP OUT OF THE REACH OF CHILDREN.

This tablet should be chewed. This product, as with all chewable tablets, are not recommended for children under age 4 due to risk of choking.

PRECAUTIONS:

The suggested dose of Multi-Vitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.

Before prescribing Multi-Vitamin with Fluoride Chewable Tablets,

• Determine the fluoride content of the drinking water from all major sources.
• Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste.
• Periodically check to make sure that the child does not develop significant dental fluorosis.

ADVERSE REACTIONS:

Allergic rash and other idiosyncrasies have been rarely reported.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-1800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION:

One tablet daily or as prescribed.

HOW SUPPLIED:

Multi-Vitamin with Fluoride Chewable Tablets 0.25 mg are available as orange, red and purple chewable tablets imprinted with "151" in 100 tablet bottles, NDC 51862-151-01.

Multi-Vitamin with Fluoride Chewable Tablets 0.5 mg are available as orange, red and purple chewable tablets imprinted with "152" in 100 tablet bottles, NDC 51862-152-01.

Multi-Vitamin with Fluoride Chewable Tablets 1.0 mg are available as orange, red and purple chewable tablets imprinted with "153" in 100 tablet bottles, NDC 51862-153-01.

STORAGE:

Store at a controlled room temperature 20º-25ºC (68º-77ºF) excursions permitted between 15º-30ºC (59º-86ºF) [See USP].

WARNING; KEEP OUT OF THE REACH OF CHILDREN In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Manufactured for:
Libertas Pharma, Inc.
Lawrenceville, GA 30043
Iss. 03/11   151-01       743620

Container Label

NDC 51862-151-01

Rx Only

Multi-Vitamin

with Fluoride

Chewable Tablets

0.25 mg

Multi Vitamin and Fluoride Supplement

100 Tablets

Libertas
Pharma Inc.