FDA Label for Stool Softener Laxative
View Indications, Usage & Precautions
Stool Softener Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Equaline (supervalu). 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 100 mg
Purpose
Stool softener laxative
Uses
- for temporary relief 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 1-855-423-2630
Principal Display Panel
compare to Dulcolax® Stool Softener active ingredient†
stool softener
docusate sodium 100 mg
stool softener laxative
- comfortable relief of painful, hard, dry stool
- stimulant-free
- constipation relief
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.
DISTRIBUTED BY UNFI
PROVIDENCE, RI 02908 USA
Product Label
EQUALINE Stool Softener Laxative
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