{"active_ingredient":["Active ingredient (in each softgel) Docusate sodium 100 mg"],"ask_doctor":["Ask a doctor before use if you have stomach pain nausea vomiting a sudden change in bowel habits that lasts over 2 weeks"],"do_not_use":["Do not use if you are presently taking mineral oil, unless told to do so by a doctor."],"dosage_and_administration":["Directions take only by mouth. Doses may be taken as a single daily dose or in divided doses. adults and children 12 years and over take 1-3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor"],"dosage_and_administration_table":["<table><col width=\"1px\"/><col width=\"1px\"/><tbody><tr><td styleCode=\" Toprule\">adults and children 12 years and over</td><td styleCode=\" Toprule Lrule\">take 1-3 softgels daily </td></tr><tr><td styleCode=\" Toprule\">children 2 to under 12 years of age </td><td styleCode=\" Toprule Lrule\">take 1 softgel daily </td></tr><tr><td styleCode=\" Toprule\">children under 2 years </td><td styleCode=\" Toprule Lrule\">ask a doctor </td></tr></tbody></table>"],"effective_time":"20251217","id":"91e9523b-ba92-4e22-b50c-1f798ce0ba96","inactive_ingredient":["Inactive ingredients ammonium hydroxide, anhydrous citric acid, D&C red #33, ethyl alcohol, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mineral oil, n-butyl alcohol, polyethylene glycol, potassium hydroxide, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide"],"indications_and_usage":["Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 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 (1-800-222-1222) right away."],"openfda":{"application_number":["M007"],"brand_name":["Stool Softener Laxative"],"generic_name":["DOCUSATE SODIUM"],"is_original_packager":[true],"manufacturer_name":["CARDINAL HEALTH 110, LLC. DBA LEADER 70000"],"package_ndc":["70000-0091-3","70000-0091-2","70000-0091-1"],"product_ndc":["70000-0091"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["91e9523b-ba92-4e22-b50c-1f798ce0ba96"],"spl_set_id":["da5ccd75-8a2f-4f90-ae8a-97d81b8579d2"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"],"upc":["0096295138528"]},"package_label_principal_display_panel":["Principal Display Panel COMPARE TO COLACE® REGULAR STRENGTH active ingredient Stool Softener Docusate Sodium 100 mg Stool Softener Laxative Gentle & Effective Relieves Constipation Stimulant-Free SOFTGELS** **Liquid-Filled Capsules TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. †This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., distributor of Colace® Regular Strength. ©2026 Cardinal Health, CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313","Product Label LEADER Stool Softener Docusate Sodium 100 mg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Stool softener laxative"],"questions":["Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST"],"set_id":"da5ccd75-8a2f-4f90-ae8a-97d81b8579d2","spl_product_data_elements":["Stool Softener Laxative DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE D&C RED NO. 33 FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITAN SORBITOL TITANIUM DIOXIDE AMMONIA ISOPROPYL ALCOHOL LECITHIN, SOYBEAN MINERAL OIL BUTYL ALCOHOL ALCOHOL POTASSIUM HYDROXIDE PC18"],"stop_use":["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. you need to use a laxative for more than 1 week"],"storage_and_handling":["Other information each softgel contains :sodium 5 mg store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)"],"version":"7","warnings":["Warnings Do not use 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 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. you need to use a laxative for more than 1 week 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 (1-800-222-1222) right away."]}