MultiVitamin with Fluoride

One tablet daily or as directed by a physician.

Other Ingredients: ascorbic acid, cholecalciferol, compressible sugar, cyanocobalamin, dl-alpha-tocopheryl acetate, 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, sodium fluoride, stearic acid, sucralose, thiamine mononitrate and vitamin A acetate.

Active ingredient for caries prophylaxis: Fluoride as sodium fluoride.

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.

MultiVitamin 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(OH2) + 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 of saliva.

MultiVitamins with Fluoride Chewable Tablets offer supplementation of the diet with 10 vitamins and fluoride.

Allergic rash and other idiosyncrasies have been rarely reported.

To report SUSPECTED ADVERSE REACTIONS, contact H2-Pharma, LLC at 1 (866) 592-6438 or FDA at 1 (800) 332-1088 or via the web at www.fda.gov/medwatch/index.html for voluntary reporting of adverse reactions.

MultiVitamin with Fluoride Chewable Tablets 0.25 mg are available as orange chewable tablets imprinted with "155" in 100 tablet bottles.

MultiVitamin with Fluoride Chewable Tablets 0.5 mg are available as orange chewable tablets imprinted with "156" in 100 tablet bottles.

MultiVitamin with Fluoride Chewable Tablets 1.0 mg are available as orange chewable tablets imprinted with "157" in 100 tablet bottles.

Store at controlled room temperature 20°C-25°C (68°-77°F), excursions permitted between 15°-30°C (59°-86°F) [See USP].

Distributed by:
H2-Pharma, LLC
Montgomery, AL 36117

61269-155-01

MultiVitamin
with Fluoride
Chewable Tablets

0.25 mg

MultiVitamin and Fluoride Supplement

Dietary Supplement
Orange Flavor

100 Tablets

H² pharma

[image: MM1]

61269-156-01

MultiVitamin
with Fluoride
Chewable Tablets

0.5 mg

MultiVitamin and Fluoride Supplement

Dietary Supplement
Orange Flavor

100 Tablets

H² pharma

[image: MM2]

61269-157-01

MultiVitamin
with Fluoride
Chewable Tablets

1 mg

MultiVitamin and Fluoride Supplement

Dietary Supplement
Orange Flavor

100 Tablets

H² pharma

[image: MM3]