{"active_ingredient":["Active ingredient (in each 10 mL cup) Docusate sodium 100 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 2 weeks"],"do_not_use":["Do not use if you are presently taking mineral oil, unless told to do so by a doctor"],"dosage_and_administration":["Directions: Dose once daily take with 6 to 8 oz of milk, juice or infant formula to mask the bitter taste. adults and children 12 years and older 5 to 20 mL (1 to 4 teaspoonfuls) children 6 to under 12 years of age 5 to 10 mL (1 to 2 teaspoonfuls) children 3 to under 6 years of age 2.5 to 5 mL (1/2 to 1 teaspoonful) children under 3 years ask a doctor"],"dosage_and_administration_table":["<table width=\"100%\" styleCode=\"Noautorules\"><col width=\"49%\"/><col width=\"49%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>adults and children 12 years and older</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>5 to 20 mL (1 to 4 teaspoonfuls)</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>children 6 to under 12 years of age</paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>5 to 10 mL (1 to 2 teaspoonfuls)</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>children 3 to under 6 years of age</paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>2.5 to 5 mL (1/2 to 1 teaspoonful)</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>children under 3 years</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>"],"effective_time":"20250420","id":"328399bd-5afd-f961-e063-6294a90a7c0a","inactive_ingredient":["Inactive ingredients: artificial cherry vanilla flavoring, citric acid anhydrous, D&C Red No. 33, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, saccharin sodium, sodium citrate, and sorbitol."],"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":{"application_number":["M007"],"brand_name":["Docusate Sodium"],"generic_name":["DOCUSATE SODIUM"],"is_original_packager":[true],"manufacturer_name":["American Health Packaging"],"package_ndc":["60687-878-42","60687-878-48","60687-878-56"],"product_ndc":["60687-878"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1245686"],"spl_id":["328399bd-5afd-f961-e063-6294a90a7c0a"],"spl_set_id":["e5028f6d-d33d-47a9-8453-00af5cdf59a6"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"]},"package_label_principal_display_panel":["Principal Display Panel – Tray Label Case NDC 60687-878-56/Cup NDC 60687-878-42 Docusate Sodium Liquid 100 mg/10 mL STOOL SOFTENER LAXATIVE Alcohol Free/Sugar Free USUAL DOSAGE: See attached Drug Facts Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. For Institutional Use Only T0935C101224 R12/24 100 mg 10mL Docusate Sodium Liquid Tray.jpg","Principal Display Panel – Cup – 100 mg / 10 mL NDC 60687- 878 -42 Docusate Sodium Liquid Stool Softener Laxative 100 mg/10 mL Alcohol Free/Sugar Free Delivers 10 mL Protect from freezing. Protect from light. See package Drug Facts insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 F0935C100125 100 mg 10mL Docusate Sodium Liquid Lid.jpg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Stool softener"],"questions":["Questions or comments? Call 1-800-845-8210 DO NOT USE IF SEAL IS BROKEN."],"set_id":"e5028f6d-d33d-47a9-8453-00af5cdf59a6","spl_product_data_elements":["Docusate Sodium Docusate Sodium ANHYDROUS CITRIC ACID D&C RED NO. 33 GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SACCHARIN SODIUM SORBITOL SOLUTION DOCUSATE SODIUM DOCUSATE Clear pink to purple-pink Cherry-Vanilla"],"spl_unclassified_section":["Drug Facts","Distributed by: American Health Packaging Columbus, OH 43217 R12/24"],"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. you need to use a stool softener laxative for more than 1 week rash occurs"],"storage_and_handling":["Other information Sodium content: 28 mg / 10 mL Store at controlled room temperature, 20° to 25°C (68° to 77°F) Protect from freezing Protect from light Clear pink to purple pink colored, cherry-vanilla flavored liquid supplied in the following: 10 mL unit dose cups: 100 cups (10 x 10) NDC 60687-878-56"],"version":"1","warnings":["Warnings Do not use 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 2 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. you need to use a stool softener laxative for more than 1 week rash occurs 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."]}