STOOL SOFTNER- docusate sodium capsule, liquid filled

STOOL SOFTNER by

Drug Labeling and Warnings

STOOL SOFTNER by is a Otc medication manufactured, distributed, or labeled by Denton Pharma, Inc. DBA 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) 687-0176 Mon- Fri 8 AM to 4 PM

* This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.

Principal Display Panel

NDC: 70934-364-30

INGREDIENTS AND APPEARANCE

STOOL SOFTNER 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70934-364(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: 70934-364-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/09/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	05/09/2019

Labeler - Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)

Registrant - Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)

Establishment
Name	Address	ID/FEI	Business Operations
Denton Pharma, Inc. DBA Northwind Pharmaceuticals		080355546	repack(70934-364)