{"active_ingredient":["Active ingredient (in each softgel) Docusate Sodium 100 mg"],"dosage_and_administration":["Directions • take only by mouth • take softgels with a full glass (8 oz) of water adults and children 12 years of age and older take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses. children 6 to under 12 years of age take 1 softgel daily or as directed by a doctor children under 6 years of age ask a doctor"],"dosage_and_administration_table":["<table width=\"40%\"><caption/><tbody><tr><td styleCode=\"Rrule Toprule Botrule\">adults and children 12 years of age and older</td><td styleCode=\"Lrule Toprule Botrule\">take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses. </td></tr><tr><td styleCode=\"Rrule Toprule Botrule\">children 6 to under 12 years of age</td><td styleCode=\"Lrule Toprule Botrule\">take 1 softgel daily or as directed by a doctor</td></tr><tr><td styleCode=\"Rrule Toprule Botrule\">children under 6 years of age</td><td styleCode=\"Lrule Toprule Botrule\">ask a doctor</td></tr></tbody></table>"],"effective_time":"20251210","id":"8f5fe2d1-2047-45f5-8e9f-a5440b78132b","inactive_ingredient":["Inactive ingredients FD&C Red No.40, FD&C Yellow No.6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan solution"],"indications_and_usage":["Uses • relieves occasional constipation (irregularity) • this product generally produces a bowel movement within 12 to 72 hours."],"keep_out_of_reach_of_children":["Keep out of reach of children Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M007"],"brand_name":["Docusate Sodium"],"generic_name":["DOCUSATE SODIUM"],"is_original_packager":[true],"manufacturer_name":["Major Pharmaceuticals"],"package_ndc":["0904-7609-61"],"product_ndc":["0904-7609"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["8f5fe2d1-2047-45f5-8e9f-a5440b78132b"],"spl_set_id":["3e8321cf-7eda-d70c-e063-6394a90a35a5"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"],"upc":["0309047609611"]},"package_label_principal_display_panel":["Packaging MAJOR docusate sodium stool softener laxative"],"purpose":["Purpose Stool softener laxative"],"questions":["Questions or comments? 1(888) 577-8033"],"set_id":"3e8321cf-7eda-d70c-e063-6394a90a35a5","spl_product_data_elements":["Docusate Sodium Docusate Sodium DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL WATER SORBITOL SORBITAN D1"],"spl_unclassified_section":["Drug Facts","NDC 0904-7609-61 MAJOR ® docusate sodium docusate sodium 100 mg stool softener laxative • stimulant-free • relief of occasional constipation 100 softgels (10x10) unit dose Distributed by: MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com Made in India CT0904760961 REV.00-092025 Rev. 10/25 M-173 Re-order No. 701455 READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING."],"storage_and_handling":["Other information • each softgel contains: sodium 5 mg (very low sodium) • store at controlled room temperature 20–25°C (68–77°F) • protect from light, heat and moisture"],"version":"3","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 • abdominal pain, nausea, or vomiting • a sudden change in bowel habits that lasts over 14 days 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 no bowel movement after using this product. These can 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 care professional before use. Keep out of reach of children Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms."]}