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 15o-30oC (59o-86oF).

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®.

HOW SUPPLIED

Product: 50090-2375

NDC: 50090-2375-1 100 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 50090-2375-2 60 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 50090-2375-4 30 CAPSULE, LIQUID FILLED in a BOTTLE

Docusate Sodium

STOOL SOFTNER
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50090-2375(NDC:66424-399)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50090-2375-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/26/2016
2	NDC:50090-2375-2	60 in 1 BOTTLE; Type 0: Not a Combination Product	04/26/2016
3	NDC:50090-2375-4	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/26/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	03/01/2016

Labeler - A-S Medication Solutions (830016429)

Name	Address	ID/FEI	Business Operations
Establishment
A-S Medication Solutions		830016429	RELABEL(50090-2375) , REPACK(50090-2375)

Drug Facts