FDA Label for Stool Softener Extra Strength
View Indications, Usage & Precautions
Stool Softener Extra Strength Product Label
The following document was submitted to the FDA by the labeler of this product Bryant Ranch Prepack. 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 the prevention of dry, hard stools
- 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 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 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, polyethylene glycol, propylene glycol*, purified water, sorbitol special
*may contain this ingredient
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
How Supplied
Product: 71335-0632
NDC: 71335-0632-1 30 CAPSULE, LIQUID FILLED in a BOTTLE
NDC: 71335-0632-2 60 CAPSULE, LIQUID FILLED in a BOTTLE
NDC: 71335-0632-3 100 CAPSULE, LIQUID FILLED in a BOTTLE
NDC: 71335-0632-4 7 CAPSULE, LIQUID FILLED in a BOTTLE
* Please review the disclaimer below.