{"active_ingredient":["Active ingredient (in each softgel) Docusate Sodium 250 mg"],"dosage_and_administration":["Directions adults and children 12 years and older: take 1 softgel daily or as directed by a doctor children under 12: do not use do not exceed recommended dose"],"effective_time":"20260604","id":"53728778-9acd-ab94-e063-6294a90a47ec","inactive_ingredient":["Inactive ingredients FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerol, PEG, purified water, sorbitol special"],"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"],"manufacturer_name":["NuCare Pharmaceuticals, Inc."],"original_packager_product_ndc":["57896-426"],"package_ndc":["68071-5297-6"],"product_ndc":["68071-5297"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1245468"],"spl_id":["53728778-9acd-ab94-e063-6294a90a47ec"],"spl_set_id":["53727f3a-914c-0e2c-e063-6394a90a3886"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"],"upc":["0368071529760"]},"package_label_principal_display_panel":["package Label pdp"],"purpose":["Purpose Stool Softener"],"questions":["Questions or comments? 1-800-540-3765"],"set_id":"53727f3a-914c-0e2c-e063-6394a90a3886","spl_product_data_elements":["Stool Softener DOCUSATE SODIUM GELATIN GLYCERIN FD&C YELLOW NO. 6 FOOD YELLOW 3 FREE ACID WATER FD&C RED NO. 40 POLYETHYLENE GLYCOL, UNSPECIFIED SORBITOL DOCUSATE SODIUM DOCUSATE oblong SCU1"],"storage_and_handling":["Other information each softgel contains: sodium 15 mg store at 59°-77°F (15°-25°C) keep tightly closed product of Romania Package not child resistant Tamper Evident: Do not use if imprinted seal under cap is missing or broken"],"version":"1","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."]}