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 P & L Development, 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
Do Not Use
if you are presently taking mineral oil, unless told to do so 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 (1-800-222-1222) right away.
Directions
- take only by mouth. Doses may be taken as a single daily dose 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 permitted between 15-30°C (59-86°F)
Inactive Ingredients
black iron oxide, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
†Compare to the active ingredient in Colace® Regular Strength Stool Softener
stool softener
docusate sodium 100 mg
stool softener laxative
Softgels
†This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace Regular Strength Stool Softener.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Distributed by: PL Developments
200 Hicks Street, Westbury, NY 11590
Product Label
WELLNESS BASICS Stool Softener Laxative
* Please review the disclaimer below.