{"active_ingredient":["Active ingredient (in each softgel ) Docusate sodium 100 mg"],"ask_doctor":["Ask a doctor before use if you have abdominal pain nausea vomiting noticed a sudden change in bowel habits that lasts over a period of 2 weeks"],"do_not_use":["Do not use if you are presently taking mineral oil, unless directed by a doctor"],"dosage_and_administration":["Directions Take only by mouth. Doses may be taken as a single daily dose or in divided doses. Adults and children 12 years and over take 1-3 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><col width=\"157\"/><col width=\"126\"/><tbody><tr><td styleCode=\"Rrule \"><content styleCode=\"bold\">Adults and children 12 years and over</content></td><td styleCode=\"Lrule \">take 1-3 softgels daily</td></tr><tr><td styleCode=\"Toprule Rrule \"><content styleCode=\"bold\">Children 2 to under 12 years of age</content></td><td styleCode=\"Toprule Lrule \">take 1 softgel daily</td></tr><tr><td styleCode=\"Toprule Rrule \"><content styleCode=\"bold\">Children under 2 years</content></td><td styleCode=\"Toprule Lrule \">ask a doctor</td></tr></tbody></table>"],"effective_time":"20240627","id":"9f60cac9-8c8b-41b0-964b-b30d15e8f808","inactive_ingredient":["Inactive ingredients black edible ink, citric acid, D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol solution, 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 accidental overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M007"],"brand_name":["Fleet"],"generic_name":["DOCUSATE SODIUM"],"is_original_packager":[true],"manufacturer_name":["C.B. Fleet Company, Inc."],"package_ndc":["0132-0402-25"],"product_ndc":["0132-0402"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["9f60cac9-8c8b-41b0-964b-b30d15e8f808"],"spl_set_id":["56a7b6c5-d674-4eed-91c2-77f7d18fff32"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"]},"other_safety_information":["Other information each softgel contains: sodium 5 mg VERY LOW SODIUM store at 25°C (77°F) excursions permitted between 15°– 30°C (59°–86°F)"],"package_label_principal_display_panel":["Pr incipal Display Panel Fleet Docusate sodium 100 mg Stool Softener Oral Laxative 25 softgels Principal Display Panel Fleet Docusate sodium 100 mg Stool Softener Oral Laxative 25 softgels"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Stool softener"],"questions":["Questions? Call 1-866-255-6960"],"set_id":"56a7b6c5-d674-4eed-91c2-77f7d18fff32","spl_product_data_elements":["Fleet docusate sodium DOCUSATE SODIUM DOCUSATE CITRIC ACID MONOHYDRATE D&C RED NO. 33 FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 GLYCERIN GELATIN POLYETHYLENE GLYCOL, UNSPECIFIED SORBITOL SOLUTION WATER PROPYLENE GLYCOL PC18"],"spl_unclassified_section":[""],"stop_use":["Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These symptoms may indicate a serious condition. you need to use a stool softener laxative for more than 1 week"],"version":"2","warnings":["Warnings Do not use if you are presently taking mineral oil, unless directed by a doctor Ask a doctor before use if you have abdominal pain nausea vomiting noticed a sudden change in bowel habits that lasts over a period of 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These symptoms may indicate a serious condition. 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 accidental overdose, get medical help or contact a Poison Control Center right away."]}