DOCUSATE SODIUM capsule, liquid filled

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by Northwind Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
  

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

• 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

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51655-342(NDC:66424-399)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	red (Two toned- white and clear red)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	SCU2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51655-342-20	20 in 1 BOTTLE; Type 0: Not a Combination Product	08/14/2017
2	NDC: 51655-342-52	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/25/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	08/14/2017

Labeler - Northwind Pharmaceuticals (036986393)

Registrant - Northwind Pharmaceuticals (036986393)

Establishment
Name	Address	ID/FEI	Business Operations
Northwind Pharmaceuticals		036986393	repack(51655-342)