LEADER STOOL SOFTENER PLUS STIMULANT LAXATIVE SOFTGEL- docusate sodium, sennosides capsule, liquid filled

LEADER Stool Softener Plus Stimulant Laxative SOFTGEL by

Drug Labeling and Warnings

LEADER Stool Softener Plus Stimulant Laxative SOFTGEL by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 110, LLC. DBA Leader. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each softgel)

Docusate sodium 50 mg
Sennosides 8.6 mg

Purpose

Stool softener
Stimulant laxative

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 6 to 12 hours

Warnings

Do not use
laxative products for longer than 1 week unless told to do so by a doctor
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.

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

take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.

• adults and children 12 years and over: take 2-4 softgels daily
• children 6 to under 12 years and over: take 1-2 softgels daily
• children under 6 years of age: ask a doctor

Other information

each softgel contains: sodium 4 mg
store at room temperature between 20°-25°C (68°-77°F)

Inactive ingredients

colloidal silicon dioxide, FD&C red #40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide, yellow bees wax

Questions or comments?

Call 1-800-200-6313

SPL UNCLASSIFIED SECTION

COMPARE TO COLACE® 2-IN-1 active ingredients*

All LEADER™ Brand Products Have A 100% Money Back Guarantee
Return to place of purchase if not satisfied.

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313
Essential to Care™ Since 1979

Product of India

©2024 Cardinal Health. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

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

*This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., owner of the registered trademark COLACE® 2-IN-1.

Packaging

INGREDIENTS AND APPEARANCE

LEADER STOOL SOFTENER PLUS STIMULANT LAXATIVE SOFTGEL 
docusate sodium, sennosides capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0684
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
YELLOW WAX (UNII: 2ZA36H0S2V)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	903
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0684-1	1 in 1 CARTON	07/16/2024
1		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	07/16/2024

Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)