{"active_ingredient":["Active Ingredient (in each softgel) Docusate Sodium 100mg Purpose Stool softener"],"ask_doctor":["Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks"],"dosage_and_administration":["Directions adults and children over 12 years of age: take 1 to 3 softgels preferably at bedtime children 6- 12 years of age: take 1 softgel at bedtime"],"effective_time":"20150106","id":"190d5b06-30b1-4783-b626-d25976c57167","inactive_ingredient":["Inactive Ingredients edible ink, FDandC Red #40, FDandC Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special."],"indications_and_usage":["Uses for the prevention of dry, hard stools for relief of occasional constipation. This product generally produces a bowel movement within 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":["Distributed by : Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, U.S.A. Rev. 2/09","Principal Display Panel Principal Display Panel-Docusate Sodium 100mg Docusate Sodium Capsule 100mg unit dose label"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding ask a health care professional before use."],"purpose":["Purpose Stool softener"],"questions":["Questions or comments? Adverse Drug Event Call: (800)-616-2471)"],"set_id":"7cdecfb2-e09a-4b48-b9d6-00045518825e","spl_product_data_elements":["Docusate Sodium DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL ORANGE P51 OVAL"],"stop_use":["Stop use and ask a doctor if you have rectal bleeding you fail to have a bowel movement after use"],"storage_and_handling":["Other information each softgel contains: sodium 6mg store at controlled room temperature 15 o - 30 o C (59 o - 86 o F) *This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Colace ®"],"version":"8","warnings":["Warnings - Do not use if you are currently taking mineral oil, unless directed by a doctor when abdominal pain, nausea or vomiting are present for longer than 1 week, unless directed by a doctor Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks Stop use and ask a doctor if you have rectal bleeding you fail to have a bowel movement after use If pregnant or breastfeeding ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."]}