{"active_ingredient":["ACTIVE INGREDIENT (IN EACH SOFTGEL) DOCUSATE SODIUM 250 MG"],"dosage_and_administration":["DIRECTIONS adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor children under 12 years of age: ask a doctor"],"effective_time":"20240913","id":"220d2464-6ee6-10d6-e063-6394a90a4f39","inactive_ingredient":["INACTIVE INGREDIENTS edible ink, FD&C red #40, FD&C yellow #6, gelatin (bovine), glycerin, polyethylene glycol, purified water, sorbitol special."],"indications_and_usage":["USES for the prevention of dry, hard stools for relief of occasional constipation this product generally produces a bowel movement within 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":["DOCUSATE SODIUM, EXTRA STRENGTH 250 MG"],"generic_name":["DOCUSATE SODIUM"],"is_original_packager":[true],"manufacturer_name":["Advanced Rx LLC"],"package_ndc":["80513-100-01"],"product_ndc":["80513-100"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1245468"],"spl_id":["220d2464-6ee6-10d6-e063-6394a90a4f39"],"spl_set_id":["e8be12c5-c591-eadd-e053-2a95a90a431b"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"]},"package_label_principal_display_panel":["01b lbl-PDP_Docusate Sodium_250mg_100 01b lbl-DF_Docusate Sodium_250mg_100"],"purpose":["PURPOSE Stool softener laxative"],"questions":["QUESTIONS? call 1-800-630-8895"],"set_id":"e8be12c5-c591-eadd-e053-2a95a90a431b","spl_product_data_elements":["DOCUSATE SODIUM, EXTRA STRENGTH 250 MG DOCUSATE SODIUM FD&C YELLOW NO. 6 FD&C RED NO. 40 GLYCERIN GELATIN TYPE B BOVINE (160 BLOOM) POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITOL SOLUTION DOCUSATE SODIUM DOCUSATE SCU1"],"storage_and_handling":["OTHER INFORMATION each softgel contains: sodium 20 mg store at 20°- 25°C (68°- 77°F); excursions permitted between 15°-30°C (59°-86°F)"],"version":"4","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 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 laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use."]}