Active Ingredient (In Each 5 Ml = 1 Teaspoonful)
Docusate Sodium 50 mg
Docusate Sodium Liquid
FDA Label NDC 48433-220
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safecor Health, Llc for the product Docusate Sodium (NDC 48433-220). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 5 ml = 1 teaspoonful), purpose, use:, otc - do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stool Softener
Use:
Relief of occasional constipation
Otc - 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
Otc - 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
Otc - 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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health care professional before use.
Otc - 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.
Dosage & Administration
Directions: * Must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation | |
| 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 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.
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
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 - Lid Label
Delivers 10 mL
NDC 48433-220-10
Docusate
Sodium Liquid
100 mg/10mL
SHAKE WELL
348433220108
Pkg By: Safecor Health, LLC
Columbus, OH 43204
PN5618.B
* Please review the disclaimer below.
