{"active_ingredient":["Active Ingredient (In each softgel) Docusate Sodium.... 100 mg"],"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"],"effective_time":"20250109","id":"2b4a8b5e-8724-3c78-e063-6394a90a194d","inactive_ingredient":["Gelatin, Glycerin, Sorbitol Sorbitan solution, Purified water , D&C Red #40, D&C Yellow #6, White 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":["Docusate sodium"],"generic_name":["DOCUSATE SODIUM"],"is_original_packager":[true],"manufacturer_name":["APNAR PHARMA LP"],"package_ndc":["24689-130-01"],"product_ndc":["24689-130"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["2b4a8b5e-8724-3c78-e063-6394a90a194d"],"spl_set_id":["05b0732b-012f-78ee-e063-6294a90a839a"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"],"upc":["0324689130019"]},"package_label_principal_display_panel":["NDC 24689-130-01 Docusate Sodium 100mg Stool Softener Laxative MADE IN USA 100 Softgels Docusate Sodium Softgel lable-100mg"],"purpose":["Purpose Stool softener laxative"],"questions":["Questions or Comments ? Call 1-855-642-2594"],"set_id":"05b0732b-012f-78ee-e063-6294a90a839a","spl_product_data_elements":["Docusate sodium Docusate sodium GELATIN GLYCERIN SORBITOL DOCUSATE SODIUM DOCUSATE SORBITAN FD&C YELLOW NO. 6 WATER FD&C RED NO. 40 Oblong AD2"],"spl_unclassified_section":["Compare to the active ingredient in Colace® Regular Strength Stool Softener† †This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength Stool Softener. Rev.: 03/2023 Manufactured by: Apnar Pharma LLP East Windsor, NJ 08520"],"storage_and_handling":["Other Information each softgel contains: sodium 5 mg store between 20ºC - 25ºC (68-77ºF);excursions permitted between 15-30ºC (59-86ºF)"],"version":"2","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 last 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 a signs of a serious condition. you need to use a stool softner laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use."]}