FDA Label for Docusate Sodium
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH SOFTGEL)
- PURPOSE
- USES
- DO NOT USE
- 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 INFORMAITON
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
Docusate Sodium Product Label
The following document was submitted to the FDA by the labeler of this product Marlex Pharmaceuticals 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 directed 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
Ask A Doctor Or Pharmacist Before Use If You Are
taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
Stop Use And Ask A Doctor If
- you have rectal bleeding or fail to have a bowel movement after use of a laxative.
- you need to use stool softner laxative for more than 1 week
These could be sings of a serious condition.
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
| adults and children 12 years and over | take 1 - 3 softgels once daily or in divded doses |
| children 2 to under 12 years of age | 1 softgel once daily |
| children under 2 years | ask a doctor |
Other Informaiton
- each softgel contains: sodium 7 mg
- store at room temperature 15°-25°C (59°-77°F) and avoid excessive heat
Inactive Ingredients
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400 NF, purified water, sorbitol
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
*Marlex Pharmaceuticals, Inc., is not affiliated with the owner of the trademark Colace®
Distributed by:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720
Made in Romania
Principal Display Panel
NDC 10135-0111-01
Docusate Sodium
100 mg
100 Softgels
* Please review the disclaimer below.