{"active_ingredient":["Active Ingredient (in each 5 mL = 1 teaspoonful) Docusate Sodium 50 mg"],"ask_doctor":["Ask a doctor before use if you * have noticed a sudden change in bowel habits that persist over a period of 2 weeks * are taking mineral oil"],"do_not_use":["Do not use * when abdominal pain, nausea, or vomiting are present * for a period longer than 1 week unless directed by a doctor"],"dosage_and_administration":["Directions: * Must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation * Shake well before using * Do not exceed recommended dose * May be taken in one to four equally divided oral doses each day * Take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response Adults and children 12 years of age and over 5 mL (1 teaspoon) to 40 mL (8 teaspoons) or as directed by a doctor Children 6 to 12 years of age 4 mL to 15 mL (3 teaspoons) or as directed by a doctor Children 3 to 6 years of age 2 mL to 6 mL or as directed by a doctor Children under 3 years of age 1 mL to 4 mL or as directed by a doctor 1 teaspoon = 5 mL Other information: Each teaspoon (5 mL) contains: sodium 5 mg. Store at room temperature 20°C-25°C (68°F-77°F); excursions between 15°C-30°C (59°F-86°F) are allowed. Protect from excessive heat. Protect from light. For more info call 1-800-447-1006. Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, and sucralose. NDC: 48433-220-10 Docusate Sodium Liquid 100 mg/10 mL Unit Dose Cup Mfd. in the U.S.A. Distributed by: Safecor Health, LLC 4060 Business Park Drive, Columbus, OH 43204 Rev: 11/2020 PN5473 3 4843322010 8"],"dosage_and_administration_table":["
Directions: * Must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation * Shake well before using * Do not exceed recommended dose * May be taken in one to four equally divided oral doses each day * Take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response
Adults and children 12 years of age and over5 mL (1 teaspoon) to 40 mL (8 teaspoons) or as directed by a doctor
Children 6 to 12 years of age4 mL to 15 mL (3 teaspoons) or as directed by a doctor
Children 3 to 6 years of age2 mL to 6 mL or as directed by a doctor
Children under 3 years of age1 mL to 4 mL or as directed by a doctor
"],"effective_time":"20250108","id":"3b918dfb-629d-4eef-ba71-d2ee2f97747f","inactive_ingredient":["Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, and sucralose. NDC: 48433-220-10 Docusate Sodium Liquid 100 mg/10 mL Unit Dose Cup Mfd. in the U.S.A. Distributed by: Safecor Health, LLC 4060 Business Park Drive, Columbus, OH 43204 Rev: 11/2020 PN5473 3 4843322010 8"],"indications_and_usage":["Use: Relief of occasional constipation"],"keep_out_of_reach_of_children":["Keep this and all drugs out of reach of children . In case of overdose, get medical help or contact a Poison Control Center immediately. In case of eye contact, flush with water."],"openfda":{"application_number":["M334"],"brand_name":["DOCUSATE SODIUM"],"generic_name":["DOCUSATE SODIUM"],"manufacturer_name":["Safecor Health, LLC"],"original_packager_product_ndc":["54859-813"],"package_ndc":["48433-220-10"],"product_ndc":["48433-220"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1248119"],"spl_id":["3b918dfb-629d-4eef-ba71-d2ee2f97747f"],"spl_set_id":["efe4bf81-fb99-4755-aa23-4f8df5973be8"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"],"upc":["0348433220405"]},"other_safety_information":["Other information: Each teaspoon (5 mL) contains: sodium 5 mg. Store at room temperature 20°C-25°C (68°F-77°F); excursions between 15°C-30°C (59°F-86°F) are allowed. Protect from excessive heat. Protect from light. For more info call 1-800-447-1006."],"package_label_principal_display_panel":["Principal Display Panel - Box Label SAFECOR HEALTH Docusate Sodium Liquid 100 mg / 10 ml Contains 40 (10 ml) Unit Dose Cups See monograph for complete drug information. NDC: 48433-220-40 QTY: 40 Lot: 21A0079 Exp: 2023-03-31 Store at room temperature 20°C-25°C (68°F-77°F); excursions between 15°C-30°C (59°F-86°F) are allowed. Protect from excessive heat. Protect from light. This package design is not child resistant. For institutional use only. Shake well before use. 3 48433 22040 5 Pkg By: Safecor Health, LLC Columbus, OH 43204 Questions or Comments: Call 1-800-447-1006 GTIN: 00348433220405 SN: 212802331 Exp; 2023-03-31 Lot 21A0079 PN5689.C Principal Display Panel - Box Label","Principal Display Panel - Lid Label Delivers 1 0 mL NDC 48433-220-10 Docusate Sodium Liquid 100 mg/10mL SHAKE WELL 348433220108 Pkg By: Safecor Health, LLC Columbus, OH 43204 PN5618.B Principal Display Panel - Lid Label"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding , ask a health care professional before use."],"purpose":["Purpose Stool Softener"],"set_id":"efe4bf81-fb99-4755-aa23-4f8df5973be8","spl_product_data_elements":["DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 METHYLPARABEN POLOXAMER 124 POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM BENZOATE SODIUM CITRATE SUCRALOSE"],"stop_use":["Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement within 3 days. These could be signs of a serious condition. * a skin rash occurs * you experience throat irritation"],"version":"3","warnings":["WARNINGS: Do not use * when abdominal pain, nausea, or vomiting are present * for a period longer than 1 week unless directed by a doctor Ask a doctor before use if you * have noticed a sudden change in bowel habits that persist over a period of 2 weeks * are taking mineral oil Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement within 3 days. These could be signs of a serious condition. * a skin rash occurs * you experience throat irritation If pregnant or breast feeding , ask a health care professional before use. Keep this and all drugs out of reach of children . In case of overdose, get medical help or contact a Poison Control Center immediately. In case of eye contact, flush with water."]}