Active Ingredient (In Each Softgel)
Docusate Calcium 240 mg
Stool Softener Capsule, Liquid Filled
FDA Label NDC 0363-0868
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 0363-0868). 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 you have, 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
Stool softener laxative
Uses
- for relief of occasional constipation
- this product generally produces a bowel movement within 12 to 72 hours
Do Not Use
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 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 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
- adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
- children under 12 years of age: ask a doctor
Other Information
- store between 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients
corn oil, D&C red #33, edible white ink, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, purified water, sorbitol special
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to Surfak® active ingredient††
Stool Softener
DOCUSATE CALCIUM 240 mg /
STOOL SOFTENER LAXATIVE
SOFTGELS
- Gentle relief of constipation
- Take once a day
Sodium free
††This product is not manufactured or distributed by Chattem Inc., distributor of Surfak®.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED 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
Product Label
WALGREENS Stool Softener
* Please review the disclaimer below.
