{"active_ingredient":["Active ingredient (in each softgel) Docusate Sodium 100 mg"],"ask_doctor":["Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel movements that lasts over 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 to 3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor"],"dosage_and_administration_table":["
adults and children 12 years and overtake 1 to 3 softgels daily
children 2 to under 12 years of agetake 1 softgel daily
children under 2 yearsask a doctor
"],"effective_time":"20241218","id":"51a3d159-6238-4f52-aef6-9d07e09bd201","inactive_ingredient":["Inactive Ingredients D&C Red No. 33, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerol, Polyethylene glycol, purified water, sorbitol, titanium dioxide"],"indications_and_usage":["Uses relieves occasional constipation (irregularity) generally produces a bowel movement in 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 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":["76162-777-99"],"product_ndc":["76162-777"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["51a3d159-6238-4f52-aef6-9d07e09bd201"],"spl_set_id":["9342c1b5-5d35-4b60-b347-c208c0774cdc"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"]},"package_label_principal_display_panel":["Display Panel DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 ©TOPCO RSEA0621 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Stool softener"],"set_id":"9342c1b5-5d35-4b60-b347-c208c0774cdc","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, UNSPECIFIED PROPYLENE GLYCOL SORBITOL WATER Two-Tone OVAL SCU2"],"spl_unclassified_section":["Drug Facts"],"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":["Other information each softgel contains: sodium 5 mg VERY LOW SODIUM store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat Image of carton"],"version":"4","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 movements 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 stool softener laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."]}