Stool Softener Laxative
Drug Facts
cb2df470-aef6-4c75-9596-6e50694d881e
HUMAN OTC DRUG LABEL
Jul 30, 2025
Strategic Sourcing Services LLC
DUNS: 116956644
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DOCUSATE SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (13)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product Label
SUNMARK Stool Softener Laxative
INDICATIONS & USAGE SECTION
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
OTC - PURPOSE SECTION
Purpose
Stool softener laxative
DOSAGE & ADMINISTRATION SECTION
Directions
- take only by mouth. Doses may be taken as a single daily dose or in divided doses.
|
adults and children 12 years and over |
take 1-3 softgels daily |
|
children 2 to under 12 years of age |
take 1 softgel daily |
|
children under 2 years |
ask a doctor |
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each softgel)
Docusate sodium 100 mg
WARNINGS SECTION
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 laxative for more than 1 week
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.
STORAGE AND HANDLING SECTION
Other information
*each softgel contains:sodium 6 mg
- store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)
INACTIVE INGREDIENT SECTION
Inactive ingredients
D&C red #33*, edible ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide
*contains one or more of these ingredients
OTC - QUESTIONS SECTION
Questions or comments?
Call1-877-753-3935 Monday-Friday 9AM-5PM EST