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 LABELING
Stool Softener Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Care One (american Sales Company). 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 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 with a glass of water
adults and children 12 years 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 at 25°C (77°F); 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
*may contain one or more of these ingredients
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredient in DulcoEase® Stool Softener
STOOL SOFTENER LAXATIVE
Docusate Sodium 100 mg
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.
DISTRIBUTED BY FOODHOLD U.S.A., LLC
LANDOVER, MD 20785 •1-877-846-9949
©2017 S&S Brands,LLC
Product Labeling
CAREONE Stool Softener Laxative Softgels
* Please review the disclaimer below.