Active Ingredient (In Each Softgel)
Docusate Sodium 100 mg
Stool Softener Laxative Capsule
FDA Label NDC 37808-862
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H E B for the product Stool Softener Laxative (NDC 37808-862). 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 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
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 directed by a doctor
Ask A Doctor Before Use If You Have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that last 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 a 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 with a glass of water
| adults and children 12 years and over | take 1 to 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 at 25°C (77°F);excursions 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 toll free: 1-877-753-3935, Monday-Friday, 9AM-5PM EST
Principal Display Panel
Compare to Dulcolax® Stool Softener active ingredient**
Stool Softener
Laxative
Docusate Sodium 100 mg
Stool Softener Laxative
Fast, Dependable Relief of Occasional Constipation
SOFTGELS
**This product is not manufactured or distributed by Chattem, Inc., 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.
MADE WITH PRIDE AND CARE FOR H-E-B®, SAN ANTONIO, TX 78204
Product Label
H-E-B Stool Softener Laxative
* Please review the disclaimer below.
