Active ingredient (in each softgel)

Docusate sodium 250 mg

Purpose

Stool softener laxative

Uses

for the prevention of dry, hard stools
for relief of occasional constipation
this product generally produces a bowel movement within 12 to 72 hours

Warnings

Do not use

if you are presently taking mineral oil, unless directed by a doctor.

Ask a doctor before use if you have

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that last 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 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.

Directions

adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
children under 12 years of age: ask a doctor

Other information

each softgel contains: sodium 15 mg
store at 20-25ºC(68º-77ºF); excursions permitted between 15-30ºC (59º-86ºF)

Inactive Ingredients

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitol special

*may contain this ingredient

Questions or comments?

Call 1-877-753-3935 Monday- Friday 9AM-5PM EST

Principal Display Panel

Extra Strength

Stool Softener Laxative

Docusate Sodium, 250 mg

Stimulant-Free

Relieves Occasional Constipation

SOFTGELS

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

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

Product Label

LEADER Extra Strength Stool Softener Laxative

STOOL SOFTENER EXTRA STRENGTH
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0385
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	250 mg

Ingredient Name	Strength
Inactive Ingredients
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	orange	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	P20;SCU1
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0385-1	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2018	12/27/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	09/30/2018	12/27/2024

Labeler - Cardinal Health (Leader) 70000 (063997360)

Drug Facts