DOCUSATE SODIUM- docusate sodium capsule, liquid filled 
Northwind Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Docusate Sodium 100mg

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

Warnings


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

adults and children 12 years and over                        take 1-3 softgels daily
children 2 to under 12 years of agetake 1 softgel daily
children under 2 yearsask a doctor

Other information

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

51655-342-20

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

51655-342-52

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

51655-342-25

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

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51655-342(NDC:66424-399)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorred (Two toned- white and clear red) Scoreno score
ShapeOVALSize12mm
FlavorImprint Code SCU2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51655-342-2020 in 1 BOTTLE; Type 0: Not a Combination Product08/14/2017
2NDC:51655-342-5230 in 1 BOTTLE; Type 0: Not a Combination Product01/25/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/14/2017
Labeler - Northwind Pharmaceuticals (036986393)
Registrant - Northwind Pharmaceuticals (036986393)
Establishment
NameAddressID/FEIBusiness Operations
Northwind Pharmaceuticals036986393repack(51655-342)

Revised: 3/2015
Document Id: 82fb2524-1ae9-3c80-e053-2991aa0a1219
Set id: 82fab9f8-fdf2-fd32-e053-2a91aa0af596
Version: 1
Effective Time: 20150302
 
Northwind Pharmaceuticals