{"active_ingredient":["Active ingredient (in each softgel) Docusate Sodium 100 mg"],"dosage_and_administration":["Directions • adults and children 12 years and older: take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor • children under 12: consult a doctor • do not exceed recommended dose"],"effective_time":"20170407","id":"652595d2-d594-4cd1-b02e-ed3690b69642","inactive_ingredient":["Inactive ingredients FD and C red #40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol special, water. May also contain D and C yellow #10, FD and C yellow #6 (sunset yellow), mannitol. Compare to active ingredient in Colace R * *This product is not manufactured or distributed by the owner of the registered trademark Colace R . DIST. BY: GERI-CARE PHARMACUETICALS CORP. 1650 63rd Street, Brooklyn, NY 11204 REV 0112 Cardinal Health Zanesville, OH 43701 IT48469450613"],"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."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel Stool Softener Docusate Sodium 100 mg Softgels card label","Principal Display Panel Stool Softener Docusate Sodium 100 mg softgels QTY 28 lidding label","Package Label Stool Softener Docusate Sodium 100 mg each QTY 30 Softgels Blister label","Card Label Stool Softener Docusate Sodium 100 mg each card label"],"purpose":["Purpose Stool Softener Laxative"],"set_id":"29f615e2-b624-4295-81ba-6d4bec2fc7b5","spl_product_data_elements":["Stool Softener Docusate Sodium DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SORBITOL WATER D&C YELLOW NO. 10 FD&C YELLOW NO. 6 MANNITOL reddish SCU1"],"storage_and_handling":["Other information • each softgel contains: sodium 5 mg. very low sodium • store at 15°C-25°C(59° F-77° F) • keep tightly closed • product from USA or Canada • Tamper Evident: Do not use if imprinted seal under cap is missing or broken."],"version":"6","warnings":["Warnings Ask a doctor before use if you • have stomach pain, nausea or vomiting • have a sudden change in bowel habits that persists over a period of 2 weeks • are presently taking mineral oil Stop use and ask a doctor if • you need to use a laxative longer than 1 week • you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition. 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."]}