{"active_ingredient":["Active ingredient(s) Docusate sodium 100mg"],"ask_doctor":["Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over a period of 2 weeks"],"do_not_use":["Do not use if you are presently taking mineral oil, unless told to do so by a doctor"],"dosage_and_administration":["Directions 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 1-3 softgels daily Children 2 to under 12 years of age : Take 1 softgel daily Children under 2 years: Ask a doctor"],"effective_time":"20210219","id":"8d7c4d0b-d04c-4423-ba3a-dd93c58b2a9b","inactive_ingredient":["Inactive ingredients Black edible ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special"],"indications_and_usage":["Use(s) 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"openfda":{"application_number":["M007"],"brand_name":["Topcare Stool Softener"],"generic_name":["DOCUSATE SODIUM"],"is_original_packager":[true],"manufacturer_name":["TopCo Associates, LLC"],"package_ndc":["76162-006-60","76162-006-01","76162-006-81"],"product_ndc":["76162-006"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["8d7c4d0b-d04c-4423-ba3a-dd93c58b2a9b"],"spl_set_id":["6f4fddda-4129-4087-b0e4-ababc5558484"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"]},"package_label_principal_display_panel":["Principal Display Panel Stool Softener Stool Softener Stool Softener Stool Softener"],"pregnancy_or_breast_feeding":["Pregnancy/Breastfeeding ask a health professional before use."],"purpose":["Purpose Stool softener"],"questions":["Questions Call 1-888-952-0050 Monday through Friday 9am-5pm"],"set_id":"6f4fddda-4129-4087-b0e4-ababc5558484","spl_product_data_elements":["Topcare Stool Softener Docusate Sodium DOCUSATE SODIUM DOCUSATE ANHYDROUS CITRIC ACID D&C RED NO. 33 FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SORBITOL SOLUTION WATER PC18"],"spl_unclassified_section":["Other information each capsule contains: sodium 5mg VERY LOW SODIUM"],"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 stool softener laxative for more than 1 week"],"storage_and_handling":["Storage store 25°C (77°F) excursions permitted between 15°– 30°C (59°–86°F)"],"version":"8","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 stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over a period of 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 stool softener laxative for more than 1 week Pregnancy/Breastfeeding ask a health professional before use. Keep out of reach of children In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."]}