{"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"],"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 1-3 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 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":"20220919","how_supplied":["HOW SUPPLIED Product: 63629-7656 NDC: 63629-7656-1 60 CAPSULE, LIQUID FILLED in a BOTTLE NDC: 63629-7656-2 90 CAPSULE, LIQUID FILLED in a BOTTLE NDC: 63629-7656-3 18 CAPSULE, LIQUID FILLED in a BOTTLE"],"id":"fab48cae-d7be-49f0-a2f0-37ed7f8cedbb","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":{},"package_label_principal_display_panel":["DOCUSATE SODIUM 100 MG CAPSULE Label Image"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Stool softener"],"questions":["Questions? Adverse drug event call: (800) 687-0176 Mon- Fri 8 AM to 4 PM * This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®."],"set_id":"3eaea029-6d65-4de1-bdef-25ced89dac50","spl_product_data_elements":["STOOL SOFTNER Docusate Sodium DOCUSATE SODIUM DOCUSATE D&C RED NO. 33 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED SORBITOL TITANIUM DIOXIDE SCU2 Two toned- white and clear red"],"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 Tamper Evident: do not use if safety seal under cap is broken or missing each capsule contains: sodium 6 mg VERY LOW SODIUM store at 25°C (77°F); excursions permitted between 15 o -30 o C (59 o -86 o F). Keep tightly closed. This Package for Households Without Young Children"],"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 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 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)."]}