{"active_ingredient":["Active ingredient (in each softgel) Docusate Sodium 100 mg"],"ask_doctor":["Ask a doctor before use if you have stomach pain, nausea or vomiting a sudden change in bowel habits that lasts more than 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 with a glass of water -see Overdose warning adults and children 12 years of age and over 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses children 2 to under 12 years of age 1 softgel daily children under 2 years of age ask a doctor"],"dosage_and_administration_table":["<table border=\"0.1\" width=\"100%\"><tbody><tr><td styleCode=\"Toprule Botrule Lrule Rrule\"><paragraph>adults and children 12 years</paragraph><paragraph>of age and over</paragraph></td><td styleCode=\"Toprule Botrule Lrule Rrule\"><paragraph>1 to 3 softgels daily. This dose may be taken as a single daily dose</paragraph><paragraph>or in divided doses</paragraph></td></tr><tr><td styleCode=\"Toprule Botrule Lrule Rrule\">children 2 to under 12 years of age</td><td styleCode=\"Lrule Rrule Toprule Botrule\">1 softgel daily</td></tr><tr><td styleCode=\"Toprule Botrule Lrule Rrule\">children under 2 years of age</td><td styleCode=\"Toprule Botrule Lrule Rrule\">ask a doctor</td></tr></tbody></table>"],"effective_time":"20241118","id":"272c86f1-f22a-2ebf-e063-6394a90a3471","inactive_ingredient":["Inactive Ingredients citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol sorbitan solution, purified water and white edible ink"],"indications_and_usage":["Use for relief of occasional constipation and irregularity. This product generally produces bowel movement in 12 to 72 hours."],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M007"],"brand_name":["Stool Softener"],"generic_name":["DOCUSATE SODIUM 100MG"],"is_original_packager":[true],"manufacturer_name":["PuraCap Pharmaceutical LLC"],"package_ndc":["51013-819-01"],"product_ndc":["51013-819"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["272c86f1-f22a-2ebf-e063-6394a90a3471"],"spl_set_id":["272c86f1-f229-2ebf-e063-6394a90a3471"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"],"upc":["0351013819012"]},"overdosage":["Overdose warning In case of overdose, get medical help or contact a Posion Control Center right away."],"package_label_principal_display_panel":["PuraVation Stool Softener Docusate Sodium - 100 mg EACH 100 SOFTGELS NDC 51013-819-01 PC09-00 DSS 100mg-100ct.jpg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Stool softener laxative"],"questions":["Questions or comments? Call toll free: 1-855-215-8180"],"set_id":"272c86f1-f229-2ebf-e063-6394a90a3471","spl_product_data_elements":["Stool Softener Docusate Sodium 100mg GELATIN, UNSPECIFIED DOCUSATE SODIUM DOCUSATE PROPYLENE GLYCOL SORBITOL FD&C RED NO. 40 WATER ANHYDROUS CITRIC ACID POLYETHYLENE GLYCOL, UNSPECIFIED FD&C YELLOW NO. 6 GLYCERIN clear red PC1"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition. you need to use a laxative for more than 1 week."],"storage_and_handling":["Other information each softgel contains: sodium 5mg store at room temperature 15°-30° C (59°-86° F). Protect from excessive humidity contains FD&C Yellow No. 6"],"version":"1","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 or vomiting a sudden change in bowel habits that lasts more than 2 weeks Stop use and ask a doctor if you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition. you need to use a laxative for more than 1 week. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning In case of overdose, get medical help or contact a Posion Control Center right away."]}