FDA Label for Docusate Sodium
View Indications, Usage & Precautions
Docusate Sodium Product Label
The following document was submitted to the FDA by the labeler of this product Northwind Pharmaceuticals. 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
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 told 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
Stop Use And Ask A Doctor If
- you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
- you need to use a stool softener 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 (1-800-222-1222).
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
- Tamper Evident: do not use if safety seal under cap is broken or missing
- each capsule contains: sodium 6 mg
- VERY LOW SODIUM
- store at 25°C (77°F); excursions permitted between 15 o-30 oC (59 o-86 oF).
Keep tightly closed.
This Package for Households Without Young Children
Inactive Ingredients
D&C Red #33,Edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, titanium dioxide
Questions?
Adverse drug event call: (800) 722-0772 Mon- Fri 8 AM to 5 PM
* This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.
Package Label.Principal Display
NDC: 51655-342-20
MFG: 66424-399-10
Docusate Sodium 100 MG
20 Capsules
OTC
Lot#:
Exp. Date:
Each tablet contains 100 mg docusate sodium and 6 mg of sodium
Dosage: See prescriber's instructions
Store between 59-86 degrees F. Protect from light & moisture.
Keep out of the reach of children.
Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729
Dist. by: SDA Laboratories, Inc Greenwich, CT 06830 Lot#:
Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256
NDC: 51655-342-52
MFG: 66424-399-10
Docusate Sodium 100 MG
30 Capsules
OTC
Lot#:
Exp. Date:
Each tablet contains 100 mg docusate sodium and 6 mg of sodium
Dosage: See prescriber's instructions
Store between 59-86 degrees F. Protect from light & moisture.
Keep out of the reach of children.
Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729
Dist. by: SDA Laboratories, Inc Greenwich, CT 06830 Lot#:
Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256
NDC: 51655-342-25
MFG: 66424-030-10
Docusate Sodium 100 MG
60 Capsules
OTC
Lot#:
Exp. Date:
Each tablet contains 100 mg docusate sodium and 6 mg of sodium
Dosage: See prescriber's instructions
Store between 59-86 degrees F. Protect from light & moisture.
Keep out of the reach of children.
Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729
Dist. by: SDA Laboratories, Inc Greenwich, CT 06830 Lot#:
Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256
* Please review the disclaimer below.
