{"adverse_reactions":["ADVERSE REACTIONS Allergic rash and other idiosyncrasies have been rarely reported."],"clinical_pharmacology":["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. 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 forms 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 the water, food, supplementary fluoride and smaller amounts from saliva. Chemical Structure"],"description":["Nutrition Facts Serving Size 1 Chewable Tablet Serving Per Container 30 or 90 Amount Per Serving (1 Chewable Tablet) 1.0 mg 0.5 mg 0.25 mg %DV Adults & Children 4 Years or More Vitamin A 2500 IU 2500 IU 2500 IU 50% Vitamin C 60 mg 60 mg 60 mg 100% Vitamin D 400 IU 400 IU 400 IU 100% Vitamin E 15 IU 15 IU 15 IU 50% Thiamin 1.05 mg 1.05 mg 1.05 mg 70% Riboflavin 1.2 mg 1.2 mg 1.2 mg 70% Niacin 13.5 mg 13.5 mg 13.5 mg 68% Vitamin B6 1.05 mg 1.05 mg 1.05 mg 53% Folate 0.3 mg 0.3 mg 0.3 mg 75% Vitamin B12 4.5 mcg 4.5 mcg 4.5 mcg 75% Fluoride 1.0 mg 0.5 mg 0.25 mg Daily Value (%DV) not established Active ingredients Fluoride as sodium fluoride. Other Ingredients Xylitol, microcrystalline cellulose, mannitol, talc, magnesium stearate, sucralose, natural flavors, citric acid."],"description_table":["<table width=\"100%\"> <col width=\"25%\" align=\"left\" valign=\"top\"/> <col width=\"15%\" align=\"right\" valign=\"top\"/> <col width=\"15%\" align=\"right\" valign=\"top\"/> <col width=\"15%\" align=\"right\" valign=\"top\"/> <col width=\"30%\" align=\"right\" valign=\"top\"/> <thead> <tr styleCode=\"Botrule\"> <th styleCode=\"Lrule Rrule\" colspan=\"5\">Nutrition Facts  Serving Size 1 Chewable Tablet  Serving Per Container 30 or 90</th> </tr> <tr> <th styleCode=\"Lrule\">Amount Per Serving  (1 Chewable Tablet)</th> <th>1.0 mg</th> <th>0.5 mg</th> <th>0.25 mg</th> <th styleCode=\"Rrule\">%DV Adults &amp; Children  4 Years or More</th> </tr> </thead> <tbody> <tr> <td styleCode=\"Lrule\">Vitamin A</td> <td>2500 IU</td> <td>2500 IU</td> <td>2500 IU</td> <td styleCode=\"Rrule\">50%</td> </tr> <tr> <td styleCode=\"Lrule\">Vitamin C</td> <td>60 mg</td> <td>60 mg</td> <td>60 mg</td> <td styleCode=\"Rrule\">100%</td> </tr> <tr> <td styleCode=\"Lrule\">Vitamin D</td> <td>400 IU</td> <td>400 IU</td> <td>400 IU</td> <td styleCode=\"Rrule\">100%</td> </tr> <tr> <td styleCode=\"Lrule\">Vitamin E</td> <td>15 IU</td> <td>15 IU</td> <td>15 IU</td> <td styleCode=\"Rrule\">50%</td> </tr> <tr> <td styleCode=\"Lrule\">Thiamin</td> <td>1.05 mg</td> <td>1.05 mg</td> <td>1.05 mg</td> <td styleCode=\"Rrule\">70%</td> </tr> <tr> <td styleCode=\"Lrule\">Riboflavin</td> <td>1.2 mg</td> <td>1.2 mg</td> <td>1.2 mg</td> <td styleCode=\"Rrule\">70%</td> </tr> <tr> <td styleCode=\"Lrule\">Niacin</td> <td>13.5 mg</td> <td>13.5 mg</td> <td>13.5 mg</td> <td styleCode=\"Rrule\">68%</td> </tr> <tr> <td styleCode=\"Lrule\">Vitamin B6</td> <td>1.05 mg</td> <td>1.05 mg</td> <td>1.05 mg</td> <td styleCode=\"Rrule\">53%</td> </tr> <tr> <td styleCode=\"Lrule\">Folate</td> <td>0.3 mg</td> <td>0.3 mg</td> <td>0.3 mg</td> <td styleCode=\"Rrule\">75%</td> </tr> <tr> <td styleCode=\"Lrule\">Vitamin B12</td> <td>4.5 mcg</td> <td>4.5 mcg</td> <td>4.5 mcg</td> <td styleCode=\"Rrule\">75%</td> </tr> <tr> <td styleCode=\"Lrule\">Fluoride</td> <td>1.0 mg</td> <td>0.5 mg</td> <td>0.25 mg</td> <td styleCode=\"Rrule\"> <footnote>Daily Value (%DV) not established</footnote> </td> </tr> </tbody> </table>"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION One tablet daily or as prescribed."],"effective_time":"20180226","how_supplied":["HOW SUPPLIED Multivitamin with 1.0 mg, 0.5 mg and 0.25 mg Fluoride Chewable Tablets are all available in 30 and 90 tablet bottles. STORAGE Store in a cool dry place. Protect from light and moisture."],"id":"e5cb08fc-008c-4cbf-82be-8a3d2612e1bd","indications_and_usage":["INDICATIONS AND USAGE Supplementation of the diet with fluoride and ten essential vitamins. Multivitamin with 1.0 mg Fluoride Chewable Tablets 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. Multivitamin with 0.5 mg Fluoride Chewable Tablets provide fluoride in tablet form for children 4-6 years of age 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 of fluoride. Multivitamin with 0.25 mg Fluoride Chewable Tablets 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. Multivitamin with Fluoride Chewable Tablets supply significant amounts of vitamins A, C, D, E, thiamin, 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. 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 Multivitamin with Fluoride Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 1.0 mg Bottle Label 44946-1014-5 SCI Sancilio & Company, Inc. Developing Good Science into Great Medicine MVC ™-Fluoride 1.0mg* Multivitamin Chewable Tablets with Fluoride No dyes, artificial flavors or sugar Dietary Supplement 90 tablets Made in the U.S.A. PRINCIPAL DISPLAY PANEL - 1.0 mg Bottle Label","PRINCIPAL DISPLAY PANEL - 0.5mg Bottle Label SCI Sancilio & Company, Inc. Developing Good Science into Great Medicine 44946-1013-5 Rx Only MVC ® Fluoride 0.5mg * MULTIVITAMIN WITH FLUORIDE CHEWABLE TABLETS NO DYES, ARTIFICIAL FLAVORS OR SUGAR SACCHARIN AND GLUTEN FREE MULTIVITAMIN AND FLUORIDE SUPPLEMENT 90 Tablets Made in the U.S.A. PRINCIPAL DISPLAY PANEL - 0.5mg Bottle Label","PRINCIPAL DISPLAY PANEL - 0.25mg Bottle Label SCI Sancilio & Company, Inc. Developing Good Science into Great Medicine 44946-1012-5 Rx Only MVC ® Fluoride 0.25mg * MULTIVITAMIN WITH FLUORIDE CHEWABLE TABLETS NO DYES, ARTIFICIAL FLAVORS OR SUGAR SACCHARIN AND GLUTEN FREE MULTIVITAMIN AND FLUORIDE SUPPLEMENT 90 Tablets Made in the U.S.A. PRINCIPAL DISPLAY PANEL - 0.25mg Bottle Label"],"precautions":["PRECAUTIONS The suggested dose of Multivitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride. Before prescribing Multivitamin 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."],"set_id":"50b44fd6-8747-448f-b951-234e7e17df4f","spl_product_data_elements":["MVC Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-Tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid and cyanocobalamin Sodium Fluoride Fluoride Ion Vitamin A Palmitate Vitamin A Retinol Ascorbic Acid Ascorbic Acid Cholecalciferol Cholecalciferol .Alpha.-Tocopherol Acetate .Alpha.-Tocopherol Thiamine Mononitrate Thiamine Ion Thiamine Riboflavin Riboflavin Niacinamide Niacinamide Pyridoxine Hydrochloride Pyridoxine Folic Acid Folic Acid cyanocobalamin cyanocobalamin Citric Acid Monohydrate Malic Acid Microcrystalline Cellulose Sucralose Xylitol Talc Magnesium Stearate off white to pale yellow speckled SCI;1003 MVC Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-Tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid and cyanocobalamin Sodium Fluoride Fluoride Ion Vitamin A Palmitate Vitamin A Retinol Ascorbic Acid Ascorbic Acid Cholecalciferol Cholecalciferol .Alpha.-Tocopherol Acetate .Alpha.-Tocopherol Thiamine Mononitrate Thiamine Ion Thiamine Riboflavin Riboflavin Niacinamide Niacinamide Pyridoxine Hydrochloride Pyridoxine Folic Acid Folic Acid cyanocobalamin cyanocobalamin Citric Acid Monohydrate Malic Acid Microcrystalline Cellulose Sucralose Xylitol Talc Magnesium Stearate off white to pale yellow speckled SCI;1005 MVC Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-Tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid and cyanocobalamin Sodium Fluoride Fluoride Ion Vitamin A Palmitate Vitamin A Retinol Ascorbic Acid Ascorbic Acid Cholecalciferol Cholecalciferol .Alpha.-Tocopherol Acetate .Alpha.-Tocopherol Thiamine Mononitrate Thiamine Ion Thiamine Riboflavin Riboflavin Niacinamide Niacinamide Pyridoxine Hydrochloride Pyridoxine Folic Acid Folic Acid cyanocobalamin cyanocobalamin Citric Acid Monohydrate Malic Acid Microcrystalline Cellulose Sucralose Xylitol Talc Magnesium Stearate off white to pale yellow speckled SCI;1001"],"spl_unclassified_section":["Rx only","Manufactured by: Sancilio & Company, Inc. 3874 Fiscal Court #200 Riviera Beach, FL 33404"],"storage_and_handling":["STORAGE Store in a cool dry place. Protect from light and moisture."],"version":"5","warnings":["WARNING Keep this and all medication out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. Should be chewed. This product, as with all chewable tablets, is not recommended for children under age 4 due to risk of choking."]}