{"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":"20251210","id":"45a1661e-a42d-d175-e063-6294a90a272b","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 LEADER-0684"],"purpose":["Purpose Stool softener Stimulant laxative"],"questions":["Questions or comments? Call 1-800-200-6313"],"set_id":"0b2548d5-7346-43c8-b953-5842e8678d34","spl_product_data_elements":["LEADER Stool Softener Plus Stimulant Laxative SOFTGEL Docusate sodium, 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 DOCUSATE SODIUM DOCUSATE SENNOSIDES SENNOSIDES 903"],"spl_unclassified_section":["Drug Facts","COMPARE TO COLACE ® 2-IN-1 active ingredients* All LEADER™ Brand Products Have A 100% Money Back Guarantee Return to place of purchase if not satisfied. Cardinal Health™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ Since 1979 Product of India ©2024 Cardinal Health. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. 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 Atlantis Consumer Healthcare Inc., 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."]}