ADVERSE REACTIONS SECTION.


ADVERSE REACTIONS. Allergic rash and other idiosyncrasies have been rarely reported.

CLINICAL PHARMACOLOGY SECTION.


CLINICAL PHARMACOLOGY. It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to significant decrease in the incidence of dental caries.Multivitamin with 1.0 mg Fluoride Chewable Tablets provide sodium fluoride and ten essential vitamins in chewable tablet. Because the tablets are chewable, they provide topical as well as systemic source of fluoride.Hydroxyapatiteis 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:Ca 10(PO 4) 6(OH) + 2F- ------- Ca 10(PO 4) 6F + 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.

DESCRIPTION SECTION.


MULTIVITAMIN WITH FLUORIDE vitamin A, ascorbic acid, sodium ascorbate, cholecalciferol, alpha-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid and cyanocobalamin tablet, chewable. Each Fluoride Chewable Tablet Contains:Supplement FactsDosage Size Chewable Tablet Amount per tablet 1.0 mg %DV Adults and Children years or MoreVitamin 750 ug 50% Vitamin 60 mg 100%VItamin 10 ug 100%Vitamin 13 mg 50%Thiamine 1.05 mg 70%Riboflavin 1.2 mg 71%Niacin 13.5 mg 68%Vitamin 6 1.05 mg 53% Folate 300 ug 75%Vitamin 12 4.5 ug 75% Fluoride 1.0 mg daily value (DV) not establishedMultivitamin with Fluoride mg active ingredient for caries prophylaxis: Fluoride as sodium fluorideMultivitamin with mg Fluoride Chewable Tabletsprovide sodium fluoride and ten essential vitamins in chewable tablet.Other ingredients: ascorbic acid, cholecalciferol, compressible sugar, croscarmellose sodium, dl-alpha tocopheryl acetate, and Red 27 aluminum lake, FD and Blue aluminum lake, folic acid, grape flavor, magnesium stearate, microcrystalline cellulose, niacinamide, pyridoxine, riboflavin, sodium ascorbate, stearic acid, thiamine, vitamin A, vitamin 12.

DOSAGE & ADMINISTRATION SECTION.


DOSAGE AND ADMINISTRATION. One tablet daily, to be dissolved in the mouth or chewed before swallowing. Do not give chewable tablet to child younger than years old.

HOW SUPPLIED SECTION.


HOW SUPPLIED. Multivitamin chewable tablets containing mg fluoride are purple-colored, grape flavor, un-scored, round debossed 109 tablets are available on prescription only in bottles of 100 tablet bottles. NDC: 59088-109-59.

INDICATIONS & USAGE SECTION.


INDICATIONS AND USAGE. Supplementation of the diet with ten essential vitamins.Supplementation of the diet with fluoride for caries prophylaxis.Multivitamin with 1.0 mg Fluoride Chewable Tablets provide 1.0 mg fluoride in tablet form for children 6-16 years of age in areas where the water fluoride level is less than 0.3 ppm.Multivitamin with 1.0 mg Fluoride Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin 6, vitamin 12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in 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 supplements.Children usingMultivitamin with 1.0 mg Fluoride Chewable Tabletsregularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.Multivitamin with Fluoride Chewable Tablets is prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


Base Label. Base.

PRECAUTIONS SECTION.


PRECAUTION. The suggested dose ofMultivitamin with 1.0 mg Fluoride Chewable Tabletsshould not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.Before prescribingMultivitamin with 1.0 mg Fluoride Chewable Tablets: 1. Determine the fluoride content of the drinking water from all major sources. 2. Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste. 3. Periodically check to make sure that the child does not develop significant dental fluorosis.

STORAGE AND HANDLING SECTION.


STORAGE. Store at 20-25C (68-77F); excursions permitted to 15-30C (59-86F). See USP Controlled Room Temperature.Dispense in tight, light resistant container with child-resistant closure as defined in the USP/NF. All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

WARNINGS SECTION.


WARNING. Keep out of the reach of children. In case of accidental overdose, seek professional assistance or contact Poison Control Center immediately. Caution: Do not eat or drink dairy products within one hour of fluoride administration. Should be chewed. This product, as all chewable tablets, is not recommended for children under age due to risk of choking.