Active Ingredient (In Each Softgel)
Docusate sodium 100 mg
Stool Softener Capsule, Liquid Filled
FDA Label NDC 0363-8540
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Stool Softener (NDC 0363-8540). 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, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., directions, 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 (irregularity)
- this product generally produces bowel movement in 12 to 72 hours
Ask A Doctor Before Use If You Have
- stomach pain
- nausea
- vomiting
- a sudden change in bowel habits that lasts over 14 days
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.
Directions
- take softgels with a full glass (8 oz) of water
| adults and children 12 years and older | take 1-3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses. |
| children 6 to under 12 years of age | take 1 softgel daily or as directed by a doctor |
| children under 6 years of age | ask a doctor |
Other Information
- each softgel contains:sodium 6 mg
- store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F)
Inactive Ingredients
black iron oxide, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 7AM-6PM PST
Principal Display Panel
Compare to the active ingredient in Phillips® Stool Softener††
Stool Softener
DOCUSATE SODIUM 100 mg / STOOL SOFTENER LAXATIVE
SOFTGELS
- Gentle & dependable relief of constipation
- Stimulant free
SOFTGELS
††This product is not manufactured or distributed by Bayer HealthCare LLC., distributor of Phillips'® 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: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
Product Label
WALGREENS Stool Softener Laxative
* Please review the disclaimer below.
