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 Geritrex Llc. 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
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Ask A Doctor Before Use If You Have
- stomach pain
- nausea
- vomitting
- notice 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 bowel movement after use of laxative. These could be signs of 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 accidental overdose, get medical help or contact a Poison Control Center right away
Directions
take only by mouth. Doses may be taken as a single daily does or in divided doses.
| Adults and children 12 years and over | take 1-3 softgels daily |
| 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 6 mg
- store at 25°C (77°F); excursions premitted between 15-30°C (59-86°F)
Inactive Ingredients
D&C red #33, editable ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide
*contains one or more of these ingredients.
Questions Or Comments?
Call 1-800-736-3437
* Please review the disclaimer below.