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 Meijer, Inc.. 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 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
D&C red #33*, edible 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?
Call1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to Colace® Regular Strength Stool Softener active ingredient**
Stool Softener Laxative
Docusate Sodium 100 mg
Relieves constipation
SOFTGELS
**This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace® Regular Strength Stool Softener.
DISTRIBUTED BY MEIJER DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.com
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Product Label
Meijer Stool Softener Laxative Softgels
* Please review the disclaimer below.