FDA Label for Stool Softener
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH SOFTGEL)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Stool Softener Product Label
The following document was submitted to the FDA by the labeler of this product Equate (wal-mart Stores, Inc.) (see Also Wal-mart 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
- for temporary relief of 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 told to do so by a doctor.
Ask A Doctor Before Use If
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over 2 weeks
Ask A Doctor Or Pharmacist Before Use If You Are
presently taking mineral oil
Stop Use And Ask A Doctor If
- you have rectal bleeding or fail to have a bowel movement after using a laxative. These could be a sign 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 right away.
Directions
- take with a glass of water
adults and children 12 over 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 6 mg
- store 25°C (77°F); excursion 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
*contains one or more of these ingredients
Questions Or Comments?
Call 1-888-287-1915
Principal Display Panel
Compare to the active ingredient in DulcoEase® Stool Softener†
Stool Softener
Docusate sodium 100 mg
Stool Softener Laxative
- Comfortable Relief of Painful, Hard, Dry Stools
- Stimulant-Free
- Constipation Relief
SOFTGELS
†This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceutical, Inc., distributor of DulcoEase®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY:
Walmart Inc.,
Bentonville, AR 72716
Product Label
EQUATE Stool Softener
* Please review the disclaimer below.