LEADER STOOL SOFTENER - docusate sodium capsule, liquid filled
Cardinal Health

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.

----------

Active Ingredients (in each softgel)

Docusate Sodium 100mg

Purpose

Stool softener

Uses

relieves occasional constipation (irregularity)
generally produces a bowel movement within 12 to72 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 for more than 1 week.

If pregnant or breastfeeding

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 immediately.

Directions

Take only by mouth. Doses may be taken as a single daily does or in divided doses.

adults and children 12 years and over: take 1 to 3 softgels daily
children 2 to under 12 years of age: take 1 softgel daily
children under 2 years of age: ask a doctor

Other information

each softgel contains: sodium 6mg
store at controlled room temperature 15 - 30 degrees C (59-86 degrees F)
do not use if imprinted safety seal under cap is broken or missing.
*This product is not manufactured or distributed by Purdue Products, LP, owner of the registered trademark Colace.

Inactive Ingredients

DandC Red #33, edible ink, FDandC Blue #1, FDandC Red #40, FDandC Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special and titanium dioxide.

Questions or comments?

call toll free:1-800-200-6313

Comapre to the active ingredient Colace

Leader Stool Softener

Docusate Sodium 100mg

Relieves Constipation
Safe, Gentle, Reliable
100 Softgels

Distributed by Cardinal Health
Dublin, Ohio 43017
CIN 1382639

www.myleader.com
1-800-200-6313

All Leader Brand Products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

Product Labeling

Stool Softener

LEADER STOOL SOFTENER
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-265
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (DOCUSATE)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 33
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
PROPYLENE GLYCOL
WATER
SORBITOL
TITANIUM DIOXIDE

Product Characteristics
Color	red (RED) , white (WHITE)	Score	no score
Shape	OVAL (OVAL)	Size	8mm
Flavor		Imprint Code	P10;51A
Contains

Packaging
#	Item Code	Package Description
1	NDC:37205-265-78	100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/01/2012

Labeler - Cardinal Health (097537435)

Revised: 12/2012

Document Id: 2ededa29-e468-426e-aea9-cf48bb81a368

Set id: 399d08cd-2d3e-43dd-ba61-2249dec379a4

Version: 4

Effective Time: 20121212

Cardinal Health