FDA Label for Stool Softener
View Indications, Usage & Precautions
Stool Softener Product Label
The following document was submitted to the FDA by the labeler of this product H E B. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Softgel)
Docusate sodium 250 mg
Purpose
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 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 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
- 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
- each softgel contains: sodium 15 mg
- store between 20-25°C(68-77°F); excursions permitted between 15-30°C (59-86°F)
Inactive Ingredients
edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol
Questions Or Comments?
Call 1-877-753-3935 Monday- Friday 9AM-5PM EST
Principal Display Panel
EXTRA STRENGTH
Stool Softener
Docusate Sodium 250 mg
Stool softener laxative
Stool Softener
- Stimulant-free
- Relief of constipation
SOFTGELS
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
MADE WITH PRIDE AND CARE FOR H-E-B SAN ANTONIA, TX 78204
Product Label
H-E-B Stool Softener
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