{"active_ingredient":["Active ingredients (in each softgel) Docusate sodium 50 mg Sennosides 8.6 mg"],"dosage_and_administration":["Directions • take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses. adults and children 12 years and over take 2-4 softgels daily children 6 to under 12 years and over take 1-2 softgels daily children under 6 years of age ask a doctor"],"dosage_and_administration_table":["<table width=\"50%\"><tbody><tr><td styleCode=\"Botrule Rrule\"> adults and children 12 years and over</td><td styleCode=\"Botrule\"> take 2-4 softgels daily</td></tr><tr><td styleCode=\"Botrule Rrule\"> children 6 to under 12 years and over</td><td styleCode=\"Botrule\"> take 1-2 softgels daily</td></tr><tr><td styleCode=\"Botrule Rrule\"> children under 6 years of age</td><td styleCode=\"Botrule\"> ask a doctor</td></tr></tbody></table>"],"effective_time":"20240223","id":"028d3c2d-3eb4-4044-b308-7ce30b32b6e4","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, FD&C red #40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide, yellow bees wax"],"indications_and_usage":["Uses • relieves occasional constipation (irregularity) • generally produces bowel movement in 6 to 12 hours"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["Packaging CARDINAL-9030"],"purpose":["Purpose Stool softener Stimulant laxative"],"questions":["Questions or comments? Call 1-800-200-6313"],"set_id":"7eeeb95d-7754-43b9-a74e-3ee900b71b06","spl_product_data_elements":["Leader Stool Softener Plus Stimulant Laxative SOFTGEL Docusate sodium, Sennosides DOCUSATE SODIUM DOCUSATE SENNOSIDES SENNOSIDES SILICON DIOXIDE FD&C RED NO. 40 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL SORBITAN TITANIUM DIOXIDE YELLOW WAX 903"],"spl_unclassified_section":["Drug Facts","COMPARE TO COLACE ® 2-IN-1 active ingredients* 100% Money Back Guarantee DISTRIBUTE BY CARDINAL HEALTH DUBLIN, OHIO 43017 www. myleader.com 1-800-200-6313 Essential to Care™ since 1979 Product of India READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Avrio Health L.P., owner of the registered trademark COLACE® 2-IN-1."],"storage_and_handling":["Other information • each softgel contains : sodium 4 mg • store at room temperature between 20°-25°C (68°-77°F)"],"version":"2","warnings":["Warnings Do not use • laxative products for longer than 1 week unless told to do so by a doctor • if you are presently taking mineral oil, unless told to do so by a doctor Ask a doctor before use if you have • stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."]}