{"active_ingredient":["OTC - ACTIVE INGREDIENT SECTION Docusate Sodium 100 mg"],"dosage_and_administration":["DOSAGE & ADMINISTRATION SECTION 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 children under 6 years ask a doctor Other information each softgel contains: sodium 6 mg store between 15º-30ºC (59º-86ºF) Questions or comments? 1-800-645-2158 Principal Display Panel COMPARE TO ACTIVE INGREDIENT IN COLACE®* NON-HABIT FORMING Stool Softener Laxative Docusate Sodium USP, 100 mg SOFTGEL CAPSULES TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *Rugby Laboratories is not affiliated with the owner of the trademark Colace®. Distributed by: Rugby Laboratories 31778 Enterprise Drive Livonia, MI 48150"],"dosage_and_administration_table":["<table> <colgroup> <col/> <col/> </colgroup> <tbody> <tr> <td styleCode=\"Botrule Rrule\"> adults and children over 12 years of age</td> <td styleCode=\"Botrule\"> take 1 to 3 softgels preferably at bedtime</td> </tr> <tr> <td styleCode=\"Botrule Rrule\"> children 6-12 years of age</td> <td styleCode=\"Botrule\"> take 1 softgel at bedtime</td> </tr> <tr> <td styleCode=\"Botrule Rrule\"> children under 6 years</td> <td styleCode=\"Botrule\"> ask a doctor</td> </tr> </tbody> </table>"],"effective_time":"20150514","id":"f012ed63-10fa-4205-90a5-fedb7c6be942","inactive_ingredient":["INACTIVE INGREDIENT SECTION edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special."],"indications_and_usage":["INDICATIONS & USAGE SECTION for 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":["OTC - KEEP OUT OF REACH OF CHILDREN SECTION In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL image description"],"purpose":["OTC - PURPOSE SECTION Stool softener"],"set_id":"c95063e2-e0fc-43a4-b084-e1be88055f80","spl_product_data_elements":["DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOLS PROPYLENE GLYCOL WATER SORBITOL P51"],"version":"2","warnings":["WARNINGS SECTION 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 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 These could be signs of a serious condition. If pregnant or breast-feeding, 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."]}