{"active_ingredient":["Active ingredient (in each liquid-filled capsule) 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"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are presently taking mineral oil."],"dosage_and_administration":["Directions do not take more than directed take with a glass of water 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 to 3 capsules daily children 2 to under 12 years take 1 capsule daily children under 2 years ask a doctor"],"dosage_and_administration_table":["<table cellspacing=\"0\" cellpadding=\"0\"><col/><col/><tbody><tr><td styleCode=\" Botrule Rrule\"><paragraph>adults and children 12  years and over</paragraph></td><td styleCode=\" Botrule\">take 1 to 3 capsules daily</td></tr><tr><td styleCode=\" Botrule Rrule\">children 2 to under 12  years</td><td styleCode=\" Botrule\">take 1 capsule daily  </td></tr><tr><td styleCode=\" Rrule\">children under 2 years</td><td>ask a doctor</td></tr></tbody></table>"],"effective_time":"20230518","id":"00bf0cec-41b6-4e32-b2cc-e9f9092ec4d5","inactive_ingredient":["Inactive ingredients FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, light mineral oil, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, white 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 right away."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel MAJOR ® NDC 0904-7115-61 Unit Dose Docusate Sodium Stool Softener Laxative 100 mg This Unit Dose package is not child resistant and is Intended for Institutional Use Only. 100 Softgels 50844 ORG112075212 Distributed by: MAJOR ® PHARMACEUTICALS Livonia, MI 48152 Product of Dubai Packaged and Quality Assured in the USA Rev. 02/21 M-17 Re-order No. 701287 Major 44-752 Major 44-752"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Stool softener laxative"],"questions":["Questions or comments? (800) 616-2471"],"set_id":"4419de58-79bf-4ab7-93e5-5eea8603839b","spl_product_data_elements":["Docusate Sodium Docusate Sodium DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN ISOPROPYL ALCOHOL LIGHT MINERAL OIL MEDIUM-CHAIN TRIGLYCERIDES POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL SORBITAN clear 752"],"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 laxative for more than 1 week"],"storage_and_handling":["Other information each capsule contains: sodium 8 mg Very Low Sodium store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) protect from light, heat and moisture TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN see end flap for expiration date and lot number"],"version":"4","warnings":["Warnings Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks Ask a doctor or pharmacist before use if you are presently taking mineral oil. 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 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."]}