{"active_ingredient":["Active ingredient (in each 5 mL) Docusate sodium 50 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=\"60%\"><col width=\"50%\" align=\"left\" valign=\"top\"/><col width=\"50%\" align=\"left\" valign=\"top\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">adults and children 12 years and older</td><td styleCode=\"Rrule\">5 to 20 mL (1 to 4 teaspoonfuls)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">children 6 to under 12 years of age</td><td styleCode=\"Rrule\">5 to 10 mL (1 to 2 teaspoonfuls)</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">children 3 to under 6 years of age</td><td styleCode=\"Rrule\">2.5 to 5 mL (1/2 to 1 teaspoonful)</td></tr><tr><td styleCode=\"Lrule Rrule\">children under 3 years</td><td styleCode=\"Rrule\">ask a doctor</td></tr></tbody></table>"],"effective_time":"20221202","id":"eede7f2b-c0af-2e49-e053-2995a90a2731","inactive_ingredient":["Inactive ingredients Citric acid, D&C Red No. 33, flavoring, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, 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":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 10 mL Cup Tray Label NDC 0121-0544-10 Docusate Sodium Liquid (SUGAR FREE) 100 mg/10 mL STOOL SOFTENER LAXATIVE USUAL DOSAGE: See attached Drug Facts This unit-dose package is not child-resistant. Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. 10 x 10 mL Unit-Dose Cups Pharmaceutical Associates, Inc. Greenville, SC 29605 T0544101120 R11/20 PRINCIPAL DISPLAY PANEL - 10 mL Cup Tray Label"],"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"],"set_id":"1fcb6361-7598-4ac9-b04d-faf4397197eb","spl_product_data_elements":["Docusate Sodium Docusate Sodium SACCHARIN SODIUM PROPYLENE GLYCOL TRISODIUM CITRATE DIHYDRATE ANHYDROUS CITRIC ACID SORBITOL GLYCERIN WATER DOCUSATE SODIUM DOCUSATE"],"spl_unclassified_section":["Drug Facts","MANUFACTURED BY Pharmaceutical Associates, Inc. Greenville, SC 29605 R11/20"],"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: 14 mg/ 5 mL Store at controlled room temperature, 20° - 25°C (68° - 77°F) Protect from freezing Protect from light Purple colored, cherry flavored liquid supplied in the following: NDC 0121-0544-16: 16 fl oz (473 mL) bottle NDC 0121-0544-10: 10 mL unit dose cup. Case contains 100 unit dose cups of 10 mL packaged in 10 trays of 10 unit dose cups each. NDC 0121-0544-25: 25 mL unit dose cup. Case contains 100 unit dose cups of 25 mL packaged in 10 trays of 10 unit dose cups each."],"storage_and_handling_table":["<table width=\"60%\" styleCode=\"Noautorules\"><col width=\"35%\" align=\"left\" valign=\"top\"/><col width=\"65%\" align=\"left\" valign=\"top\"/><tbody><tr><td>NDC 0121-0544-16:</td><td>16 fl oz (473 mL) bottle</td></tr><tr><td>NDC 0121-0544-10:</td><td>10 mL unit dose cup. Case contains 100 unit dose cups of 10 mL packaged in 10 trays of 10 unit dose cups each.</td></tr><tr><td>NDC 0121-0544-25:</td><td>25 mL unit dose cup. Case contains 100 unit dose cups of 25 mL packaged in 10 trays of 10 unit dose cups each.</td></tr></tbody></table>"],"version":"7","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."]}