{"active_ingredient":["Active ingredient (in each softgel) Docusate Sodium 100 mg"],"dosage_and_administration":["Directions do not exceed recommended dose adults and children 12 years and older: take 1-3 softgels daily, usually 1 softgel daily after the first bowel movement, or as directed by a doctor. children under 12: ask a doctor"],"effective_time":"20251208","id":"45751ca7-5d7a-ecc4-e063-6294a90aa19b","inactive_ingredient":["Inactive ingredients FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin (bovine), glycerol, polyethylene glycol, sorbitol special, purified water."],"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."],"openfda":{"application_number":["M007"],"brand_name":["Stool Softener"],"generic_name":["DOCUSATE SODIUM"],"is_original_packager":[true],"manufacturer_name":["HEB"],"package_ndc":["37808-580-01"],"product_ndc":["37808-580"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["45751ca7-5d7a-ecc4-e063-6294a90aa19b"],"spl_set_id":["2efb4c5a-2c5e-acf6-e063-6394a90a934e"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"],"upc":["0197870178219"]},"package_label_principal_display_panel":["Package Label 1"],"purpose":["Purpose Stool Softener"],"questions":["Questions or comments? 1-800-540-3765"],"set_id":"2efb4c5a-2c5e-acf6-e063-6394a90a934e","spl_product_data_elements":["Stool Softener Docusate Sodium GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 SORBITOL WATER FD&C YELLOW NO. 6 DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 SCU1 reddish"],"storage_and_handling":["Other information • each softgel contains: sodium 7 mg. Very low sodium • store at 59°-77°F (15°-25°C) • keep tightly closed"],"version":"2","warnings":["Warnings Ask a doctor before use if you • have stomach pain, nausea or vomiting • have a sudden change in bowel habits that persists over a period of 2 weeks • are presently taking mineral oil Stop use and ask a doctor if • you need to use a laxative longer than 1 week • you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition. 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."]}