Stool Softener + Stimulant Laxative SOFTGEL

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]

LEADER STOOL SOFTENER PLUS STIMULANT LAXATIVE SOFTGEL- docusate sodium, sennosides capsule, liquid filled 
Cardinal Health 110, LLC. DBA Leader

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Stool Softener + Stimulant Laxative SOFTGEL

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

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

100% Money Back Guarantee

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

Product of India

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 Avrio Health L.P., owner of the registered trademark COLACE® 2-IN-1.

Packaging

CARDINAL-9030

LEADER STOOL SOFTENER PLUS STIMULANT LAXATIVE SOFTGEL 
docusate sodium, sennosides capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70000-9030
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorredScoreno score
ShapeOVALSize12mm
FlavorImprint Code 903
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70000-9030-61 in 1 CARTON01/25/202401/25/2024
160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00701/25/202401/25/2024
Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)

Revised: 2/2024