Active Ingredient (In Each Softgel)
Docusate Sodium 100 mg
Stool Softener Capsule
FDA Label NDC 69842-862
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Stool Softener (NDC 69842-862). 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 softgel), purpose, uses, do not use, ask a doctor before use if, stop use and ask a doctor if, if pregnant or breast-feeding,, 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 laxative
Uses
- for relief of occasional constipation and irregularity
- this product generally produces bowel movement in 12 to 72 hours
Do Not Use
if you are presently taking mineral oil, unless told to do so by a doctor.
Ask A Doctor Before Use If
- 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 using a laxative. These could be a sign of a serious condition
- you need to use a laxative for more than 1 week
If Pregnant Or Breast-Feeding,
ask a health care professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- take with a glass of water
| adults and children 12 over and over | take 1-3 softgels 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 softgel daily |
| children under 2 years | ask a doctor |
Other Information
- each softgel contains: sodium 5 mg
- store 25°C (77°F); excursion permitted between 15-30°C (59-86°F)
Inactive Ingredients
edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitan, sorbitol
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredient in Dulcolax® Stool Softener†
Stool Softener
DOCUSATE SODIUM, 100 mg
Stool Softener Laxative
- Guaranteed relief
- Gentle & easy
SOFTGELS
†This product is not manufactured or distributed by Purdue Products L.P., distributor of Dulcolax® Stool Softener.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
Product Label
CVS HEALTH Stool Softener Laxative
* Please review the disclaimer below.
