DOCUSATE SODIUM DOCUSATE SODIUM SAFECOR HEALTH, LLC FDA Approved Use: Relief of occasional constipation
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Substance Docusate Sodium
Route
ORAL
Applications
M334
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient (in each 5 mL = 1 teaspoonful) Docusate Sodium 50 mg
Inactive Ingredients
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
Strengths
5 ml 50 mg
Quantities
10 ml 0 ml
Treats Conditions
Use Relief Of Occasional Constipation

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0348433220405
UNII
F05Q2T2JA0
Packaging

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

Package Descriptions
  • 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

Overview

Use: Relief of occasional constipation

Indications & Usage

Use: Relief of occasional constipation

Dosage & 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

Warnings & Precautions
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.
Purpose

Purpose Stool Softener

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

Stop Use & Ask a Doctor

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

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.


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