{"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 • have noticed a sudden change in bowel habits that lasts over 2 weeks"],"do_not_use":["Do not use if you are currently taking mineral oil, unless directed by a doctor"],"dosage_and_administration":["Directions • doses may be taken as a single daily dose or in divided doses adults and children 12 years and over take 1 to 3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"50%\"/><col width=\"50%\"/><tbody><tr><td styleCode=\"Toprule \" valign=\"top\"><paragraph>adults and children 12 years and over  </paragraph></td><td styleCode=\"Toprule \" valign=\"top\"><paragraph>take 1 to 3 softgels daily  </paragraph></td></tr><tr><td valign=\"top\"><paragraph>children 2 to under 12 years of age </paragraph></td><td valign=\"top\"><paragraph>take 1 softgel daily </paragraph></td></tr><tr><td styleCode=\"Botrule \" valign=\"top\"><paragraph>children under 2 years </paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>ask a doctor </paragraph></td></tr></tbody></table>"],"effective_time":"20240201","id":"5c0507c4-d04d-4453-b688-fa1d856f751d","inactive_ingredient":["Inactive ingredients: D&C red #33, Edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, 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":["Docusate Sodium"],"generic_name":["DOCUSATE SODIUM"],"manufacturer_name":["Proficient Rx LP"],"original_packager_product_ndc":["66424-030"],"package_ndc":["63187-476-30","63187-476-60","63187-476-90","63187-476-00"],"product_ndc":["63187-476"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["5c0507c4-d04d-4453-b688-fa1d856f751d"],"spl_set_id":["f9ac0344-5864-4ac1-81bc-16878a5946c5"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"],"upc":["0363187476007"]},"package_label_principal_display_panel":["Principal Display Panel Relabeled By: Proficient Rx LP Thousand Oaks, CA 91320 63187-476-00"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Stool softener"],"questions":["Questions? Adverse drug event call (800) 687-0176"],"set_id":"f9ac0344-5864-4ac1-81bc-16878a5946c5","spl_product_data_elements":["Docusate Sodium Docusate Sodium Docusate Sodium Docusate D&C RED NO. 33 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL SORBITOL Two toned- white and clear red 51A"],"spl_unclassified_section":["Other information • each capsule contains sodium 6 mg • store at room temperature 15 o -30 o C (59 o -86 o F) • Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing"],"stop_use":["Stop use and ask a doctor if • you have rectal bleeding • you fail to have a bowel movement after use • you need to use a stool softener laxative for more than 1 week"],"version":"4","warnings":["Warnings Do not use if you are currently taking mineral oil, unless directed by a doctor Ask a doctor before use if you have • stomach pain, nausea or vomiting • have noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if • you have rectal bleeding • you fail to have a bowel movement after use • you need to use a stool softener laxative for more 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."]}