SPL UNCLASSIFIED SECTION.


MULTIVITAMIN WITH FLUORIDEDisclaimer: This drug has not been found by FDA to be safeand effective, and this labeling has not been approved by FDA.Prescribing InformationEach Fluoride Chewable Tablet Contains:Supplement FactsDosage Size Chewable TabletAmount per Tablet% DV Adults and Children4 years or MoreVitamin (as Vitamin acetate)2500 IU50%Vitamin (as ascorbic acid)60 mg100%Vitamin (as cholecalciferol)400 IU100%Vitamin (dl-alpha tocopherol acetate)15 IU50%Thiamine (as thiamine)1.05 mg70%Riboflavin (as riboflavin)1.2 mg71%Niacin (as niacinamide)13.5 mg68%Vitamin B6 (as pyridoxine HCl)1.05 mg53%Folate (as folic acid)300 mcg75%Vitamin B12 (as cyanocobalamin)4.5 mcg75%Fluoride (as sodium fluoride)1.0 mgDaily value (DV) not establishedMultivitamin with Fluoride 1.0 mg Chewable Tabletsactive ingredient for caries prophylaxis: Fluoride as sodium fluoride Multivitamin with Fluoride 1.0 mg Chewable Tabletsprovide sodium fluoride and ten essential vitamins in chewable tablet. Other ingredients: citric acid, magnesium stearate, mannitol, microcrystalline cellulose, orange flavor, sucralose, talc, xylitol.

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 Fluoride 1.0 mg 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. 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.

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 1.0 mg fluoride are round yellowish/cream tablets with orange and yellow speckles. Debossed with M165 on one side.NDC: 58657-165-90 (90 count)NDC: 58657-165-01 (100 count).

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 Fluoride 1.0 mg 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 Fluoride 1.0 mg Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, 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 using Multivitamin with Fluoride 1.0 mg Chewable Tablets regularly 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.


PRINCIPAL DISPLAY PANEL NDC 58657-165-90 Multivitamin with Fluoride Chewable Tablets 1.0 mg Orange Flavor Rx Only 90 Tablets PRINCIPAL DISPLAY PANEL NDC 58657-165-90Multivitaminwith FluorideChewable Tablets1.0 mgOrange Flavor Rx Only90 Tablets.

PRECAUTIONS SECTION.


PRECAUTION. The suggested dose of Multivitamin with Fluoride 1.0 mg Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride. Before prescribing Multivitamin with Fluoride 1.0 mg 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.

SAFE HANDLING WARNING 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.Manufactured For: Method Pharmaceuticals Fort Worth, TX 76118 Rev. 06/2019.

WARNINGS SECTION.


WARNING. Keep out of the reach of children. In case of accidental overdose, seek professional assistance or contact Poison Control Center immediately.CAUTIONDo 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.