{"active_ingredient":["Active Ingredient (in each softgel) Docusate Sodium 100 mg Purpose Stool softener laxative"],"ask_doctor":["Ask a doctor before use if you have stomach pain nausea vomiting a sudden change in bowel habits that lasts more than 2 weeks"],"do_not_use":["Do not use if you are presently taking mineral oil, unless directed 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":"20240411","id":"cd7b26e3-3c02-4d0a-aa69-4a62e20133fd","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 and irregularity generally produces a 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 Compare to active ingredient in COLACE® REGULAR STRENGTH† STOOL SOFTENER Docusate Sodium 100 mg Stool Softener Laxative Gentle dependable Stimulant-Free Softgels TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. Distributed by NORTHEAST PHARMA South Burlington, VT 05403 www.heartlandpharma.com","Product Label HEARTLAND PHARMA Stool Softener Docusate Sodium 100 mg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health care professional before use."],"purpose":["Purpose Stool softener laxative","Purpose Stool Softener Laxative"],"questions":["Questions or Comments ? Call 1- 800-383-0648"],"set_id":"35958471-f257-4432-997c-db60f04e62b8","spl_product_data_elements":["Stool Softener DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL SORBITAN P51"],"stop_use":["Stop use and ask a doctor if you have rectal bleeding or no bowel movement after using 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 25 o C (77 o ); excursions permitted between 15-30 o C (59-86 o F)"],"version":"3","warnings":["Warnings Do not use if you are presently taking mineral oil, unless directed by a doctor Ask a doctor before use if you have stomach pain nausea vomiting a sudden change in bowel habits that lasts more than 2 weeks Stop use and ask a doctor if you have rectal bleeding or no bowel movement after using 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 care 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."]}