{"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 until first bowel movement; 1 softgel daily thereafter, or as directed by a doctor • children under 12: consult a doctor"],"effective_time":"20251001","id":"1ca4d341-98ff-45a0-8d2e-65b39ed50253","inactive_ingredient":["Inactive ingredients FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerin, PEG, sorbitol special, 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":["334"],"brand_name":["Stool Softener"],"generic_name":["DOCUSATE SODIUM"],"manufacturer_name":["Preferred Pharmaceuticals Inc."],"original_packager_product_ndc":["57896-401"],"package_ndc":["68788-8919-3","68788-8919-6","68788-8919-1"],"product_ndc":["68788-8919"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["1ca4d341-98ff-45a0-8d2e-65b39ed50253"],"spl_set_id":["1d9fa4b9-3ec2-4ea2-a05a-ca46cc529167"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"]},"package_label_principal_display_panel":["Package Label Docusate Sodium 100mg"],"purpose":["Purpose Stool Softener Laxative"],"set_id":"1d9fa4b9-3ec2-4ea2-a05a-ca46cc529167","spl_product_data_elements":["Stool Softener Docusate Sodium DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SORBITOL WATER D&C YELLOW NO. 10 FD&C YELLOW NO. 6 MANNITOL reddish SCU1"],"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 • Tamper Evident: Do not use if imprinted seal under cap is missing or broken. Repackaged By: Preferred Pharmaceuticals Inc."],"version":"11","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."]}