{"active_ingredient":["Active ingredient (in each softgel) Docusate sodium 100 mg"],"ask_doctor":["Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks"],"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 width=\"508px\"><col width=\"1px\"/><col width=\"1px\"/><tbody><tr><td styleCode=\" Botrule Toprule Rrule\">adults and children 12 years and over</td><td styleCode=\" Botrule Toprule\">take 1-3 softgels daily </td></tr><tr><td styleCode=\" Botrule Rrule\">children 2 to under 12 years of age</td><td styleCode=\" Botrule\">take 1 softgel daily</td></tr><tr><td styleCode=\" Botrule Rrule\">children under 2 years </td><td styleCode=\" Botrule\">ask a doctor</td></tr></tbody></table>"],"effective_time":"20260409","how_supplied":["HOW SUPPLIED Docusate Sodium 100 mg NDC: 71335-9731-1: 30 Capsules in a BOTTLE NDC: 71335-9731-2: 100 Capsules in a BOTTLE NDC: 71335-9731-3: 60 Capsules in a BOTTLE NDC: 71335-9731-4: 120 Capsules in a BOTTLE NDC: 71335-9731-5: 90 Capsules in a BOTTLE NDC: 71335-9731-6: 180 Capsules in a BOTTLE NDC: 71335-9731-7: 10 Capsules in a BOTTLE NDC: 71335-9731-8: 28 Capsules in a BOTTLE NDC: 71335-9731-9: 56 Capsules in a BOTTLE NDC: 71335-9731-0: 18 Capsules in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504"],"id":"2f8a60f0-1546-455f-9083-ad4935b0ca01","inactive_ingredient":["Inactive ingredients citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink"],"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 (1-800-222-1222) right away."],"openfda":{"application_number":["M007"],"brand_name":["Stool Softener Laxative"],"generic_name":["DOCUSATE SODIUM"],"manufacturer_name":["Bryant Ranch Prepack"],"original_packager_product_ndc":["0904-7280"],"package_ndc":["71335-9731-1","71335-9731-2","71335-9731-3","71335-9731-4","71335-9731-5","71335-9731-6","71335-9731-7","71335-9731-8","71335-9731-9","71335-9731-0"],"product_ndc":["71335-9731"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["2f8a60f0-1546-455f-9083-ad4935b0ca01"],"spl_set_id":["d616685a-11fc-4ae0-80de-7d25c0d71ee9"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"]},"package_label_principal_display_panel":["Docusate Sodium 100 mg Capsule Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health care professional before use."],"purpose":["Purpose Stool softener laxative"],"questions":["Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST"],"set_id":"d616685a-11fc-4ae0-80de-7d25c0d71ee9","spl_product_data_elements":["Stool Softener Laxative DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL GLYCERIN CITRIC ACID MONOHYDRATE SORBITAN PC1 Oval"],"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 could be signs of a serious condition. you need to use a stool softener laxative for more than 1 week"],"storage_and_handling":["Other information each softgel contains: sodium 7 mg store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)"],"version":"104","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 vomiting noticed a sudden change in bowel habits that lasts over 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 could be signs of a serious condition. you need to use a stool softener laxative for more than 1 week If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."]}