{"active_ingredient":["Drug Facts Active ingredients (in each tablet) Docusate sodium 50 mg Sennosides 8.6 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 two weeks"],"do_not_use":["Do not use • laxative products for longer than 1 week unless told to do so by a doctor • 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, preferably in the evening, or in divided doses. adults and children 12 years and over take 2-4 tablets daily children 6 to under 12 years of age take 1-2 tablets daily children 2 to under 6 years of age take up to 1 tablet daily children under 2 years ask a doctor"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"50%\"/><col width=\"50%\"/><tbody><tr><td styleCode=\"Toprule \" valign=\"top\"><paragraph>adults and children 12 years and over</paragraph></td><td styleCode=\"Toprule \" valign=\"top\"><paragraph>take 2-4 tablets daily</paragraph></td></tr><tr><td valign=\"top\"><paragraph>children 6 to under 12 years of age</paragraph></td><td valign=\"top\"><paragraph>take 1-2 tablets daily</paragraph></td></tr><tr><td valign=\"top\"><paragraph>children 2 to under 6 years of age</paragraph></td><td valign=\"top\"><paragraph>take up to 1 tablet daily</paragraph></td></tr><tr><td styleCode=\"Botrule \" valign=\"top\"><paragraph>children under 2 years</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>"],"effective_time":"20260505","id":"a7d75ea6-df85-4047-951c-d30223309645","inactive_ingredient":["Inactive Ingredients corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide."],"indications_and_usage":["Uses • relieves occasional constipation (irregularity) • generally produces bowel movement in 6 to 12 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":{"application_number":["M007"],"brand_name":["Sennosides, Docusate Sodium"],"generic_name":["SENNOSIDES, DOCUSATE SODIUM"],"manufacturer_name":["Cardinal Health 107, LLC"],"original_packager_product_ndc":["0904-7440"],"package_ndc":["55154-0195-0"],"product_ndc":["55154-0195"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["998740"],"spl_id":["a7d75ea6-df85-4047-951c-d30223309645"],"spl_set_id":["1a21b07a-263c-41a4-ba0c-ad2dc5a295d7"],"substance_name":["DOCUSATE SODIUM","SENNOSIDES"],"unii":["F05Q2T2JA0","3FYP5M0IJX"],"upc":["0055154019507"]},"other_safety_information":["Other information • each tablet contains: calcium 5 mg • Store in a dry place at 15° – 30°C (59° – 86°F)."],"package_label_principal_display_panel":["Principal Display Panel NDC 55154-0195-0 Sennosides/Docusate Sodium 8.6 mg/50 mg Stool Softener/Stimulant Laxative 10 TABLETS 8.6mg/50mg bag label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Stool softener Stimulant laxative"],"questions":["Questions or comments? 1-800-231-4670"],"set_id":"1a21b07a-263c-41a4-ba0c-ad2dc5a295d7","spl_product_data_elements":["Sennosides, Docusate Sodium Sennosides, Docusate Sodium DOCUSATE SODIUM DOCUSATE SENNOSIDES SENNOSIDES STARCH, CORN CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 ALUMINUM LAKE FD&C RED NO. 40 ALUMINUM LAKE FD&C YELLOW NO. 6 ALUMINUM LAKE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE LIGHT MINERAL OIL POLYETHYLENE GLYCOL 400 SODIUM BENZOATE SODIUM LAURYL SULFATE STEARIC ACID TALC TITANIUM DIOXIDE 49;0"],"spl_unclassified_section":["Keep this carton for complete product information Tamper Evident: Do not use if sealed blister units are broken or damaged. Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.majorpharmaceuticals.com Overbagged with 10 tablets per bag, NDC 55154-0195-0 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. Distributed By: Cardinal Health Dublin, OH 43017 L6083711-11025 / L6083711-21025 Rev. 02/24 M-29 Re-order No. 701390"],"spl_unclassified_section_table":["<table width=\"100%\"><col width=\"33%\"/><col width=\"33%\"/><col width=\"33%\"/><tbody><tr styleCode=\"Toprule\"><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Rev. 02/24</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>M-29</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Re-order No. 701390</paragraph></td></tr></tbody></table>"],"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."],"version":"2","warnings":["Warnings . Do not use • laxative products for longer than 1 week unless told to do so by a doctor • 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 two 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. 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."]}