{"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":"20251204","id":"4525c13b-a7de-e67a-e063-6394a90a4224","inactive_ingredient":["Inactive ingredients citric acid, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, PEG, propylene glycol, purified water, sorbitol sorbitan solution, white edible ink."],"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":["Geri-Care Pharmaceutical Corp"],"package_ndc":["57896-411-10","57896-411-01"],"product_ndc":["57896-411"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["4525c13b-a7de-e67a-e063-6394a90a4224"],"spl_set_id":["1057c0bf-4bf6-ea17-e063-6294a90a5984"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"],"upc":["0357896411015"]},"package_label_principal_display_panel":["Package Label 1"],"purpose":["Purpose Stool Softener"],"questions":["Questions or comments? 1-800-540-3765"],"set_id":"1057c0bf-4bf6-ea17-e063-6294a90a5984","spl_product_data_elements":["Stool Softener Docusate Sodium FD&C RED NO. 40 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED SORBITOL WATER FD&C YELLOW NO. 6 PROPYLENE GLYCOL DOCUSATE SODIUM DOCUSATE ANHYDROUS CITRIC ACID SORBITAN OVAL PC1"],"storage_and_handling":["Other information • each softgel contains: sodium 5 mg. Very low sodium • store at 59°-77°F (15°-25°C) • keep tightly closed • Tamper Evident: Do not use if imprinted seal under cap is missing or broken."],"version":"2","warnings":["Warnings Ask a doctor before use if you • have stomach pain, nausea or vomiting • noticed a sudden change in bowel habits that lasts for over a period of 2 weeks • are presently taking mineral oil Stop use and ask a doctor if • you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition. • you need to use a laxative for longer 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."]}