{"description":["Description White to off-white, orange flavor, round-shaped chewable tablet debossed \"SCI\" on one side and \"1007\" on the other. See inside panel for additional information"],"dosage_and_administration":["Directions USE AS DIRECTED BY YOUR PHYSICIAN."],"effective_time":"20180206","id":"3b10e731-27aa-47f3-a3fa-5907ea4ace48","openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 0.5 mg Bottle Label Sancilio & Company, Inc. Developing Good Science into Great Medicine 44946-1009-9 Ludent ® - Fluoride Chews Sodium Fluoride Chewable Tablets NO DYES, ARTIFICIAL FLAVORS OR SUGAR SACCHARIN AND GLUTEN FREE CONTAINS XYLITOL 0.5 mg Dispense under a physician's order † Dietary Supplement 1000 tablets PRINCIPAL DISPLAY PANEL - 0.5 mg Bottle Label"],"precautions":["Caution Do not use this product if you are allergic to any of the ingredients. Take this product at least 2 hours before or after taking any products containing calcium (including milk, yogurt, other dairy products) or aluminum/magnesium hydroxide (e.g., certain antacids/laxatives). Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis. Account for all daily sources of fluoride intake."],"set_id":"4a63d24a-4d80-46a5-9a8c-f8949dfc382a","spl_product_data_elements":["Ludent Sodium Fluoride Sodium Fluoride Fluoride Ion Xylitol Microcrystalline Cellulose Malic Acid Magnesium Stearate Talc Anhydrous Citric Acid Sucralose White to off white SCI;1007"],"spl_unclassified_section":["Each 0.5 mg Fluoride Tablet Contains: Fluoride (as Sodium Fluoride) Each 0.5 mg Fluoride Tablet contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride (NaF). 0.5 mg","Other Ingredients Xylitol, microcrystalline cellulose, malic acid, magnesium stearate, talc, citric acid, natural orange flavor, sucralose.","Manufactured by: Sancilio & Co., Inc. Riviera Beach, FL 33404 USA rev. 12/02/11"],"spl_unclassified_section_table":["<table width=\"60%\"> <col width=\"50%\" align=\"left\" valign=\"top\"/> <col width=\"50%\" align=\"left\" valign=\"top\"/> <tbody> <tr styleCode=\"Toprule\"> <td>Fluoride (as Sodium Fluoride)<footnote> <content styleCode=\"bold\">Each 0.5 mg Fluoride Tablet contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride (NaF).</content> </footnote> </td> <td>0.5 mg</td> </tr> </tbody> </table>"],"storage_and_handling":["Storage Store in a cool, dry place at room temperature 20° - 25°C (68° - 77°F) away from heat and sunlight. Store in original container. This medical food product is formulated to be administered orally, under the ongoing supervision of a physician and is intended for the dietary management of dental caries for which a distinctive nutritional requirement of fluoride, based on recognized scientific principles, has been established by medical evaluation. The numeric identifier on this product's labeling is an assigned product code for use with pharmacy-level, health-insurance and state level reimbursement programs and is not intended to denote registration with the FDA."],"version":"3","warnings":["WARNING KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IF OVERDOSAGE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222. TABLET SHOULD BE CHEWED. THIS PRODUCT, AS WITH ALL CHEWABLE TABLETS, IS NOT RECOMMENDED FOR CHILDREN UNDER AGE 4 DUE TO RISK OF CHOKING. DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING"]}