Stool Softener Laxative
Drug Facts
816c82f8-0fa5-4b22-a226-e8f22f3eaa1d
HUMAN OTC DRUG LABEL
May 23, 2025
Walgreens
DUNS: 008965063
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 (11)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product Label
Stool Softener Docusate Sodium 100 mg
INDICATIONS & USAGE SECTION
Uses
- for relief of occasional constipation and irregularity
- this product generally produces bowel movement in 12 to 72 hours
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each softgel)
Docusate sodium USP, 100 mg
OTC - PURPOSE SECTION
Purpose
Stool softener laxative
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
- a sudden change in bowel habits that lasts over 2 weeks
Stop use and ask a doctor if
- you have rectal bleeding or no 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 (1-800-222-1222) right away.
DOSAGE & ADMINISTRATION SECTION
Directions
- take with a glass of water
|
adults and children 12 years and over |
take 1-3 liquid gels daily. This dose may be taken as a single daily dose or in divided doses. |
|
children 2 to under 12 years of age |
take 1 liquid gel daily |
|
children under 2 years |
ask a doctor |
STORAGE AND HANDLING SECTION
Other information
*each softgel contains:sodium 7 mg
- store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)
INACTIVE INGREDIENT SECTION
Inactive ingredients
citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink
OTC - QUESTIONS SECTION
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST****