{"active_ingredient":["Active ingredient In each tablet: Bisacodyl 5 mg"],"dosage_and_administration":["Directions take with a glass of water adults and children 12 years and over take 1 to 3 tablets in a single daily dose children 6 to under 12 years take 1 tablet in a single daily dose children under 6 years ask a doctor"],"dosage_and_administration_table":["<table width=\"100%\"> <col width=\"50%\"/> <col width=\"50%\"/> <tbody> <tr> <td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"> <paragraph>adults and children 12 years and over</paragraph> </td> <td styleCode=\"Botrule Toprule \" valign=\"top\"> <paragraph>take 1 to 3 tablets in a single daily dose</paragraph> </td> </tr> <tr> <td styleCode=\"Lrule Botrule \" valign=\"top\"> <paragraph>children 6 to under 12 years</paragraph> </td> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>take 1 tablet in a single daily dose</paragraph> </td> </tr> <tr> <td styleCode=\"Botrule Lrule \" valign=\"top\"> <paragraph>children under 6 years</paragraph> </td> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>ask a doctor</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20180410","id":"7cdd8002-53e2-41df-a7df-d3bc66075d8a","inactive_ingredient":["Inactive ingredients Acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow (iron oxide ochre), magnesium stearate, microcrystalline cellulose, ployethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide"],"indications_and_usage":["Uses Relieves occasional constipation and irregularity. This product generally produces bowel movement in 6 to 12 hours"],"keep_out_of_reach_of_children":["Keep Out of Reach of Children Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel Bisacodyl Tablets, USP 5 mg card label","Principal Display Panel Bisacodyl Tablets, USP 5 mg QTY 30 lidding label"],"purpose":["Purpose Stimulant laxative"],"questions":["Questions? To Report Adverse Drug Event Call: (800) 616-2471 Distributed by MAJOR PHARMACEUTICALS 31778 Enterprise Drive Livonia, MI 48150 USA MFGD By LNK, Hauppauge, NY11788 Cardinal Health Zanesville, OH 43701 IT48468120313 Rev. 9/10"],"set_id":"7b925e5a-bae9-49d8-a3f6-b56e957d8d21","spl_product_data_elements":["Bisacodyl Bisacodyl BISACODYL DEACETYLBISACODYL ACACIA APIS MELLIFERA CALCIUM SULFATE, UNSPECIFIED FORM CARNAUBA WAX MICROCRYSTALLINE CELLULOSE STARCH, CORN D&C YELLOW NO. 10 FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE SHELLAC POLYVINYL ACETATE PHTHALATE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE 5"],"storage_and_handling":["Storage Store at 25 C (77 F); excursions permitted to 15-30 C (59-86 F). Protect from excessive humidity."],"version":"5","warnings":["Warnings This package is intended for institutional use only. If pregnant or breast-feeding, ask a doctor before use. Do not use if you cannot swallow without chewing Ask a doctor before use if you have stomach pain, nausea or vomiting or a sudden change in bowel habits that lasts over 2 weeks. When using this product do not chew or crush tablet(s), do not use within 1 hour after taking an antacid or milk. When using this product you may have stomach discomfort, faintness or cramps. Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may be signs of a serious condition. Stop use and ask a doctor if you need to use a laxative for more than 1 week. If pregnant or breast-feeding, ask a health professional before use."]}