{"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":["<table ID=\"i555fcda1-1eb0-42a1-89f2-824cb47412be\" width=\"418\" border=\"1\"><tbody><tr><td>adults and children 12 years and over </td><td>take 1-3 softgels daily</td></tr><tr><td>children 2 to under 12 years of age</td><td>take 1 softgel daily</td></tr><tr><td>children under 2 years</td><td>ask a doctor</td></tr></tbody></table>"],"effective_time":"20260305","id":"43b71fc6-6af3-4f45-a946-ab9cff49f5ba","inactive_ingredient":["Inactive ingredients D&C Red #33, edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, titanium dioxide"],"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 right away. (1-800-222-1222)"],"openfda":{"application_number":["M"],"brand_name":["Docusate Sodium"],"generic_name":["DOCUSATE SODIUM 100MG"],"is_original_packager":[true],"manufacturer_name":["Pharbest Pharmaceuticals, Inc."],"package_ndc":["16103-399-08","16103-399-11"],"product_ndc":["16103-399"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["43b71fc6-6af3-4f45-a946-ab9cff49f5ba"],"spl_set_id":["025e03e0-e273-47ed-87f7-98e388abe047"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"]},"package_label_principal_display_panel":["PHARBEST NDC 16103-0399-11 *Compare to the active ingredient of Colace ® Docusate Sodium Stool Softener 1000 SOFTGELS 100 mg each THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Docusate Sodium 100 mg Softgels Package Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Stool softener"],"questions":["Questions or comments? (866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)"],"set_id":"025e03e0-e273-47ed-87f7-98e388abe047","spl_product_data_elements":["Docusate Sodium Docusate Sodium 100mg Docusate Sodium Docusate D&C RED NO. 33 FD&C Red No. 40 FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITOL TITANIUM DIOXIDE SCU2 Two-toned- white and clear red"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if you have rectal bleeding or fail to have 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 6 mg VERY LOW SODIUM store at 25 o C (77 o F); excursions permitted between 15 o -30 o C (59 o -86 o F). keep tightly closed."],"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 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. (1-800-222-1222)"]}