{"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 habits that lasts over 2 weeks"],"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"],"dosage_and_administration_table":["
adults and children 12 years and overtake 1-3 softgels daily
children 2 to under 12 years of agetake 1 softgel daily
children under 2 yearsask a doctor
"],"effective_time":"20250123","id":"2c654db9-2054-3aa0-e063-6294a90a1594","inactive_ingredient":["Inactive ingredients citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink"],"indications_and_usage":["Uses 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"openfda":{"application_number":["M007"],"brand_name":["Stool Softener Laxative"],"generic_name":["DOCUSATE SODIUM"],"manufacturer_name":["NuCare Pharmaceuticals, Inc."],"original_packager_product_ndc":["0904-7280"],"package_ndc":["68071-3784-0"],"product_ndc":["68071-3784"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["2c654db9-2054-3aa0-e063-6294a90a1594"],"spl_set_id":["2c65319f-6cf5-aa90-e063-6394a90ad662"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"],"upc":["0368071378405"]},"package_label_principal_display_panel":["Principal Display Panel compare to the active ingredient in Colace ® Regular Strength Stool Softener † docusate sodium docusate sodium 100 mg stool softener laxative gentle dependable stimulant-free softgels † This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., distributor of Colace ® Regular Strength Stool Softener. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. Distributed by: MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com","Product Label pdp"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health care professional before use."],"purpose":["Purpose Stool softener laxative"],"questions":["Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST"],"set_id":"2c65319f-6cf5-aa90-e063-6394a90ad662","spl_product_data_elements":["Stool Softener Laxative DOCUSATE SODIUM FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL GLYCERIN CITRIC ACID MONOHYDRATE SORBITAN DOCUSATE SODIUM DOCUSATE PC1 Oval"],"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 7 mg store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)"],"version":"1","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 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 care professional before use. 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."]}