{"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":["
adults and children 12 years and older5 to 20 mL (1 to 4 teaspoonfuls)
children 6 to under 12 years of age5 to 10 mL (1 to 2 teaspoonfuls)
children 3 to under 6 years of age2.5 to 5 mL (1/2 to 1 teaspoonful)
children under 3 yearsask a doctor
"],"effective_time":"20250206","id":"5cfc4685-c885-4303-a988-5009cbd8e57b","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":["PAI Holdings, LLC dba PAI Pharma"],"package_ndc":["0121-0935-16","0121-0935-05","0121-0935-40","0121-1870-10","0121-1870-00"],"product_ndc":["0121-0935","0121-1870"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1245686"],"spl_id":["5cfc4685-c885-4303-a988-5009cbd8e57b"],"spl_set_id":["e975a3f1-0e1f-4fb8-9c5f-baa75e12f2a5"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 16 fl oz (473 ML) NDC 0121-0935-16 Docusate Sodium Liquid 50 mg/5 m L STOOL SOFTENER LAXATIVE Alcohol Free/Sugar Free 16 fl oz (473 mL) Pharmaceutical Associates, Inc. Greenville, SC 29605 X0935160721 R07/21 16 fl oz (473 mL) bottle label","PRINCIPAL DISPLAY PANEL - 5 mL Cup LIdding NDC 0121-0935-05 Docusate Sodium Liquid 50 mg/5 mL STOOL SOFTENER LAXATIVE Alcohol Free/Sugar Free Package Not Child-Resistant Pharmaceutical Associates, Inc. Greenville, SC 29605 5 mL unit dose cup","PRINCIPAL DISPLAY PANEL - 10 mL Cup Lidding NDC 0121-1870-10 Docusate Sodium Liquid 100 mg/10 mL STOOL SOFTENER LAXATIVE Alcohol Free/Sugar Free Package Not Child-Resistant Pharmaceutical Associates, Inc. Greenville, SC 29605 10 mL unit dose cup"],"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":"e975a3f1-0e1f-4fb8-9c5f-baa75e12f2a5","spl_product_data_elements":["Docusate Sodium Docusate Sodium DOCUSATE SODIUM DOCUSATE ANHYDROUS CITRIC ACID D&C RED NO. 33 GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE SACCHARIN SODIUM SORBITOL SOLUTION Clear pink to purple-pink Cherry-Vanilla Docusate Sodium Docusate Sodium DOCUSATE SODIUM DOCUSATE ANHYDROUS CITRIC ACID D&C RED NO. 33 GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE SACCHARIN SODIUM SORBITOL SOLUTION Clear pink to purple-pink Cherry-Vanilla"],"spl_unclassified_section":["Drug Facts","MANUFACTURED BY Pharmaceutical Associates, Inc. Greenville, SC 29605 R12/20"],"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° to 25°C (68° to 77°F) • Protect from freezing • Protect from light • Clear pink to purple-pink colored, cherry flavored liquid supplied in the following: NDC 0121-0935-16: 16 fl oz (473 mL) bottle NDC 0121-0935-05: 5 mL unit dose cup, in a tray of ten cups. NDC 0121-1870-10: 10 mL unit dose cup, in a tray of ten cups."],"version":"9","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."]}