{"active_ingredient":["Active ingredient (in each softgel) Docusate Sodium 250 mg"],"dosage_and_administration":["Directions adults and children 12 years of age and older take 1 softgel daily or as directed by a doctor. children under 12 years of age ask a doctor"],"dosage_and_administration_table":["<table width=\"50%\"><col width=\"25%\"/><col width=\"25%\"/><tbody><tr><td styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><paragraph>adults and children 12 years of age and older</paragraph></td><td styleCode=\"Botrule Toprule \" valign=\"top\"><paragraph>take 1 softgel daily or as directed by a doctor.</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>children under 12 years of age</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>"],"effective_time":"20250501","id":"cb4d4f5a-9ae0-4cab-9806-017c6088f77f","inactive_ingredient":["Inactive ingredients gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol. Softgels are imprinted with edible, dye-free ink."],"indications_and_usage":["Uses relieves occasional constipation (irregularity) • generally produces a bowel movement within 12 to 72 hours."],"keep_out_of_reach_of_children":["Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately."],"openfda":{"application_number":["M007"],"brand_name":["COLACE EXTRA STRENGTH STOOL SOFTNER"],"generic_name":["DOCUSATE SODIUM"],"is_original_packager":[true],"manufacturer_name":["Atlantis Consumer Healthcare Inc."],"package_ndc":["67618-201-60","67618-201-12"],"product_ndc":["67618-201"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1245468","2692740"],"spl_id":["cb4d4f5a-9ae0-4cab-9806-017c6088f77f"],"spl_set_id":["34e06b05-64a5-4b3e-af38-cdcd7c1d521b"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"],"upc":["0367618000175"]},"package_label_principal_display_panel":["Principal Display Panel EXTRA STRENGTH #1 DOCTOR RECOMMENDED Stool Softner Brand COLACE Docusate Sodium, 250mg EXTRA STRENGTH Stool Softner √Gentle & Effective √Relieves Constipation √Cramp & Stimulant-Free √Dye & Preservative-Free √ 60 Clear Soft Gels Retain this carton for important information. Dis. By: Atlantis Consumer Healthcare Inc. Bridgewater, NJ 08807 USA Questions? 1-833-288-2684 ©2024 Atlantis Consumer Healthcare Inc. Colace is a registered trademark of Atlantis Consumer Healthcare Inc. A0824 Colace Extra strength 250mg 60 softgels"],"purpose":["Purpose Stool softener"],"questions":["Questions? 1-833-288-2684"],"set_id":"34e06b05-64a5-4b3e-af38-cdcd7c1d521b","spl_product_data_elements":["COLACE EXTRA STRENGTH STOOL SOFTNER Docusate Sodium GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED CROSPOVIDONE (120 .MU.M) PROPYLENE GLYCOL WATER SORBITOL DOCUSATE SODIUM DOCUSATE C250"],"spl_unclassified_section":["Drug Facts"],"storage_and_handling":["Other information each softgel contains: sodium 15mg store at 20-25°C (68-77°F). Keep carton for full product information"],"version":"3","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 can be 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 care professional before use. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately."]}