{"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 noticed a sudden change in bowel habits that last 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 to 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/><col/><tbody><tr><td styleCode=\" Botrule Toprule Rrule\">adults and children 12 years and over</td><td styleCode=\" Botrule Toprule\">take 1 to 3 softgels daily.</td></tr><tr><td styleCode=\" Botrule Rrule\">children 2 to under 12 years of age</td><td styleCode=\" Botrule\">take 1 softgel daily</td></tr><tr><td styleCode=\" Botrule Rrule\">children under 2 years</td><td styleCode=\" Botrule\">ask a doctor</td></tr></tbody></table>"],"effective_time":"20250819","id":"3cba8930-c831-4d66-e063-6394a90a0c1e","inactive_ingredient":["Inactive ingredients edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitan, sorbitol"],"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":{},"package_label_principal_display_panel":["Principal Display Panel Docusate sodium 100 mg is a orange oval softgel with imprint P51. NDC 72789-274-30 Bottles of 30 softgels Compare to the active ingredient in Colace ® Regular Strength Stool Softener† Docusate sodium 100 mg Stool Softener Laxative Softgels †This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength Stool Softener. TAMPER EVIDENT: DO NOT USE IF SEAL IS BROKEN OR MISSING FROM BOTTLE. Distributed by:","Docusate Sodium 100 mg image"],"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 1-800-616-2471"],"set_id":"6591a3ec-e125-4b45-9000-36f8f2221638","spl_product_data_elements":["Docusate Sodium DOCUSATE SODIUM FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN SORBITAN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL GLYCERIN DOCUSATE SODIUM DOCUSATE P51"],"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 a 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":"9","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 noticed a sudden change in bowel habits that last 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 a 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."]}