Active Ingredient (In Each 10 Ml)
Docusate Sodium 100 mg
Docusate Sodium Liquid
FDA Label NDC 84447-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Belleview Bio Science for the product Docusate Sodium (NDC 84447-011). 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 10 ml), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, overdosage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stool Softener Laxative
Uses
- relieves of occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Do Not Use
- for more than 1 week unless directed by a doctor
- if you are currently taking mineral oil, unless directed by a doctor
Ask A Doctor Before Use If You Have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that persist over a period of 2 weeks
Stop Use And Ask A Doctor If
- you have rectal bleeding or failure to have a bowel movement after use of a laxative. These could be signs of a serious condition.
- a skin rash occurs
- you experience throat irritation
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Overdosage
In case of overdosage, get medical help or contact a Poison Control Center right away.
Directions
- shake well before using
- must be given in a 6 oz to 8 oz glass of milk, fruit juice or infant formula to mask the bitter taste and prevent throat irritation
- take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response
- do not exceed recommended dose
- follow dosing directions below or use as directed by a doctor
| Age | Dose |
| adults and children 12 years and older | 1 to 7 teaspoonfuls |
| children 2 to under 12 years of age | 1 to 3 teaspoonfuls |
| children under 2 years of age | ask a doctor |
Other Information
- store at controlled room temperature 20°C to 25°C (68°F to 77°F)
- protect from light
- protect from excessive heat
- protect from freezing
- clear, grape-flavored liquid, supplied in the following:
NDC 81033-022-10: 10 mL unit dose cup
NDC 81033-022-50: Case containing 100 unit dose cups of 10 mL each
Inactive Ingredients
citric acid, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose
Questions Or Comments?
Call 1-833-537-4679
Other
Packaged by:
Kesin Pharma
Oldsmar, FL 34677
Rev. 04/2025
Package Label.Principal Display Panel
BULK SHIPMENT: For institutional or repackaging use only.
Docusate Sodium Liquid
50 mg per 5 mL
200,00 mL
NDC: 8447-011-01
* Please review the disclaimer below.
