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 Northeast Pharma (heartland Pharma). 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
Stool Softener Laxative
Uses
- relieves occasional constipation and irregularity
- generally produces a 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
- a sudden change in bowel habits that lasts more than 2 weeks
Stop Use And Ask A Doctor If
- you have rectal bleeding or no bowel movement after using 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 care 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 5 mg
- store at 25oC (77o); excursions permitted between 15-30oC (59-86oF)
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 1-800-383-0648
Principal Display Panel
Compare to active ingredient in COLACE® REGULAR STRENGTH†
STOOL SOFTENER
Docusate Sodium 100 mg
Stool Softener Laxative
- Gentle
- dependable
- Stimulant-Free
Softgels
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Distributed by NORTHEAST PHARMA
South Burlington, VT 05403
Product Label
HEARTLAND PHARMA Stool Softener
* Please review the disclaimer below.