FDA Label for Stool Softener Laxative
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH SOFTGEL)
- PURPOSE
- USES
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- 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 Laxative Product Label
The following document was submitted to the FDA by the labeler of this product H E B. 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
Ask A Doctor Before Use If You Have
- stomach pain
- nausea
- vomiting
- a sudden change in bowel habits that lasts more than 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 no bowel movement after using a laxative. These could be 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 years of age 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 of age | ask a doctor |
Other Information
- each softgel contains: sodium 6 mg
- store at 25°C (77°); excursions 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 toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to DulcoEase® Stool Softener active ingredient**
Stool Softener Laxative
Docusate Sodium, 100mg
Stool Softener Laxative
Fast, Dependable Relief of Occasional Constipation
SOFTGELS
**This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributor of DulcoEase®.
TAMPER EVIDENT:DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
MADE WITH PRIDE AND CARE FOR H.E.B®, SAN ANTONIO, TX 78204
Product Label
H-E-B Stool Softener Laxative
* Please review the disclaimer below.