LEADER STOOL SOFTENER- docusate sodium capsule, liquid filled 
Cardinal Health (Leader) 37205

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.

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Drug Facts

Active Ingredients (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement within 12 to 72 hours

Warning

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

Stop use and ask a doctor if you have

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be 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 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 15º-30ºC (59º-86ºF)

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

Principal Display Panel

Compare to Colace® active ingredient*    

Stool Softener

Docusate Sodium, 100 mg

Relieves Constipation
Safe, Gentle, Reliable
Softgels

Distributed by Cardinal Health
Dublin, Ohio 43017
www.myleader.com

*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®

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

Product Labeling

Docusate sodium 100 mg

LEADER Stool Softener 100 mg

LEADER STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-265
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
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)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorRED (RED) , WHITE (WHITE) Scoreno score
ShapeOVAL (OVAL) Size8mm
FlavorImprint Code P10;51A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-265-78100 in 1 BOTTLE; Type 0: Not a Combination Product03/01/201212/31/2017
2NDC:37205-265-97200 in 1 BOTTLE; Type 0: Not a Combination Product03/01/201212/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33403/01/201212/31/2017
Labeler - Cardinal Health (Leader) 37205 (097537435)

Revised: 10/2019
Document Id: ccbd4ca9-18cf-454b-acbe-9a677d61cdba
Set id: 399d08cd-2d3e-43dd-ba61-2249dec379a4
Version: 9
Effective Time: 20191001
 
Cardinal Health (Leader) 37205