{"active_ingredient":["Active ingredient (in each softgel) Docusate Sodium 100mg"],"dosage_and_administration":["Directions • Adults and children over 12 years of age and over : take 1-3 softgels daily. This dose may be taken as a single daily dose or in divided doses • Children 2 to under 12 years of age take 1 softgels daily • Children under 2 years of age: Consult a physician"],"effective_time":"20221122","id":"3b2a6a3b-0ca3-41fc-a1b3-c95d6105b042","inactive_ingredient":["Inactive ingredients FD&C Red No. 40, FD&C Yellow No.6, Gelatin, Bovine Bone, Glycerol Palm Free, Polyethylene Glycol 400 NF, Purified Water, Sorbitol Special 76%. SKY Mfg. By: Aenova Holding GmbH 14193 SW 119 th Ave., Miami, FL 33186-6013 Distributed by McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Road Concord, NC 28027 Validated with McKesson's PROmanager-Rx Automated storage & dispensing system for Package-Ready Oral solids www.PROmanager-Rx.com Distributed by Cardinal Health Dublin, OH 43017 L44377781018"],"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 this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. This package is intended for institutional use only. Consult a physician before the use of this product."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel - Bag Docusate Sodium 100 MG Softgels 10 Softgels bag label"],"purpose":["Purpose Stool Softener"],"set_id":"d159c229-318c-445b-87fb-ef0797903d35","spl_product_data_elements":["Docusate Sodium Docusate Sodium DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL SORBITOL D&C YELLOW NO. 10 FD&C YELLOW NO. 6 WATER Reddish SCU1"],"spl_unclassified_section":["Other information • each capsule contains: sodium 5 mg • store at controlled room temperature 15° - 30°C (59° - 86°F)"],"version":"9","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 have noticed 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 you are pregnant or breast-feeding, ask a health professional before use. This unit dose package is not child resistant and is Intended for Institutional Use Only."]}