{"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":"20260706","id":"55fe1154-f793-7cb6-e063-6294a90aad06","inactive_ingredient":["INACTIVE INGREDIENTS FD&C red #40, FD&C yellow #6, gelatin, glycerin, ink (edible), polyethylene glycol, propylene glycol, purified water, sorbitol."],"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":["80513-101-01"],"product_ndc":["80513-101"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1245468"],"spl_id":["55fe1154-f793-7cb6-e063-6294a90aad06"],"spl_set_id":["fc8cf24e-8ca1-b3fb-e053-6294a90a7a50"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"]},"package_label_principal_display_panel":["PDP DF"],"purpose":["PURPOSE Stool softener laxative"],"questions":["QUESTIONS? call 1-800-630-8895"],"set_id":"fc8cf24e-8ca1-b3fb-e053-6294a90a7a50","spl_product_data_elements":["DOCUSATE SODIUM, EXTRA STRENGTH 250 MG DOCUSATE SODIUM FD&C YELLOW NO. 6 PROPYLENE GLYCOL FD&C RED NO. 40 GLYCERIN GELATIN TYPE B BOVINE (160 BLOOM) POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITOL SOLUTION DOCUSATE SODIUM DOCUSATE NV12"],"storage_and_handling":["OTHER INFORMATION each softgel contains: sodium 20 mg Phenylketonurics: Contains phenylalanine 4 mg per softgel store at 15°- 25°C (59°- 77°F)"],"version":"3","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."]}