{"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 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/><col/><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":"20260107","id":"9fc25696-b92e-4f93-b5d1-9bc08177e9fb","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":["TOP CARE (Topco Associates LLC)"],"package_ndc":["36800-638-25","36800-638-60","36800-638-10"],"product_ndc":["36800-638"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["9fc25696-b92e-4f93-b5d1-9bc08177e9fb"],"spl_set_id":["44fe6ce0-5fed-418f-8a6a-d6132e288328"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"],"upc":["0036800084629"]},"package_label_principal_display_panel":["Principal Display Panel COMPARE TO COLACE® REGULAR STRENGTH STOOL SOFTENER ACTIVE INGREDIENT† Stool Softener DOCUSATE SODIUM 100 mg STOOL SOFTENER LAXATIVE Gentle Effective Relieves Constipation Stimulant-free SOFTGELS †This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., distributor of Colace® Regular Strength Stool Softener. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY TOPCO ASSOCIATES LLC ITASCA, IL 60143 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com","Product Label Top Care Stool Softener Docusate sodium 100mg"],"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 toll free 1-888-423-0139"],"set_id":"44fe6ce0-5fed-418f-8a6a-d6132e288328","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 ANHYDROUS CITRIC ACID ALCOHOL AMMONIA LECITHIN, SOYBEAN MINERAL OIL BUTYL ALCOHOL POTASSIUM HYDROXIDE ISOPROPYL ALCOHOL 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":"6","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 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."]}