{"active_ingredient":["Active ingredient (in each softgel) Docusate sodium USP 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 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 border=\"0\" width=\"100%\"><tbody><tr><td><paragraph>adults and children 12 years and over</paragraph></td><td><paragraph>take 1-3 softgels daily</paragraph></td></tr><tr><td><paragraph>children 2 to under 12 years of age</paragraph></td><td><paragraph>take 1 softgel daily</paragraph></td></tr><tr><td><paragraph>children under 2 years</paragraph></td><td><paragraph>ask a doctor</paragraph></td></tr></tbody></table>"],"effective_time":"20250819","id":"3c12b695-d508-de0f-e063-6394a90a05dd","inactive_ingredient":["Inactive ingredients D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, ferrosoferric oxide, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, shellac, sorbitol solution, 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 right away (1-800-222-1222)."],"openfda":{"application_number":["M007"],"brand_name":["Stool Softener"],"generic_name":["DOCUSATE SODIUM"],"is_original_packager":[true],"manufacturer_name":["BJWC (Berkley & Jensen / BJ's)"],"package_ndc":["68391-730-40"],"product_ndc":["68391-730"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["3c12b695-d508-de0f-e063-6394a90a05dd"],"spl_set_id":["330758d2-fc1a-50ce-e063-6294a90a7db1"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"]},"other_safety_information":["Other information each capsule contains: sodium 6 mg keep tightly closed. store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)."],"package_label_principal_display_panel":["730T Docusate Sodium 100mg 400ct 730T_BJs_Docusate Sodium 100mg 400ct_label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Stool softener"],"questions":["Questions or comments? Call 1-877-290-4008"],"set_id":"330758d2-fc1a-50ce-e063-6294a90a7db1","spl_product_data_elements":["Stool Softener Docusate Sodium DOCUSATE SODIUM DOCUSATE GLYCERIN PROPYLENE GLYCOL WATER SHELLAC POLYETHYLENE GLYCOL 400 SORBITOL SOLUTION FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED D&C RED NO. 33 TITANIUM DIOXIDE FERROSOFERRIC OXIDE 102 Pinkish red light beige translucent"],"spl_unclassified_section":["Drug Facts"],"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 stool softener laxative for more than 1 week"],"version":"2","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 stool softener 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 right away (1-800-222-1222)."]}