{"active_ingredient":["Active ingredient (in each softgel) Docusate Sodium 100 mg"],"dosage_and_administration":["Directions • 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":["
adults and children 12 years of age and oldertake 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 agetake 1 softgel daily or as directed by a doctor
children under 6 years of ageask a doctor
"],"effective_time":"20260728","id":"e7438297-555e-458e-b889-b1ca82d34d96","inactive_ingredient":["Inactive ingredients edible white ink, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, isopropyl alcohol, light mineral oil, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution"],"indications_and_usage":["Uses • for relief of occasional constipation (irregularity) • This 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 - Stool Softener Laxative"],"generic_name":["DOCUSATE SODIUM"],"manufacturer_name":["Cardinal Health 107, LLC"],"original_packager_product_ndc":["0904-7183"],"package_ndc":["55154-3369-0"],"product_ndc":["55154-3369"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["e7438297-555e-458e-b889-b1ca82d34d96"],"spl_set_id":["b5e4b14d-bf11-4309-bf6d-65ee9d877a24"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"],"upc":["0055154336901"]},"package_label_principal_display_panel":["Principal Display Panel NDC 55154-3369-0 DOCUSATE SODIUM 100 mg Stool Softener Laxative 10 SOFTGELS 100mg bag label"],"purpose":["Purpose Stool softener laxative"],"questions":["Questions or comments? (800)616-2471 ​"],"set_id":"b5e4b14d-bf11-4309-bf6d-65ee9d877a24","spl_product_data_elements":["Docusate Sodium - Stool Softener Laxative Docusate Sodium DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GLYCERIN ISOPROPYL ALCOHOL LIGHT MINERAL OIL MEDIUM-CHAIN TRIGLYCERIDES POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL SORBITAN 777"],"spl_unclassified_section":["Drug Facts","MAJOR ® Unit Dose TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION Distributed by: MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 Overbagged with 10 softgels per bag, NDC 55154-3369-0 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. Distributed By: Cardinal Health Dublin, OH 43017 L57466800124 Product of UAE Packaged and Quality Assured in the USA CT0904718361 REV.01-032022 Rev. 07/21 M-173 Re-order No. 701293"],"spl_unclassified_section_table":["
Rev. 07/21M-173Re-order No. 701293
"],"storage_and_handling":["Other information • each softgel contains: sodium 10 mg (very low sodium) • store at 25°C (77°F) in a dry place. Avoid excessive heat 40°C (140°F)."],"version":"6","warnings":["Warnings 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."]}