STOOL SOFTENER- docusate sodium capsule 
BJWC (Berkley & Jensen / BJ's)

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 Ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

Warnings - Do not use

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

Other information

Inactive Ingredients

D&C Red #33, edible ink, FD&C blue #1, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special and titanium dioxide.

Questions or Comments?

Call toll free: 1-800-934-1204 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient of COLACE®*

stool softener

Docusate sodium, 100 mg

Convenient & Predictable relief of constipation

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

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

Product Label

Berkley & Jensen

Docusate Sodium 100 mg

STOOL SOFTENER 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68391-110
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
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorRED, WHITEScoreno score
ShapeOVALSize13mm
FlavorImprint Code P10;51A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68391-110-04400 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33406/10/2013
Labeler - BJWC (Berkley & Jensen / BJ's) (159082692)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 1/2013
Document Id: 9a461566-91d5-404b-9875-7d0b04767e11
Set id: 0a0ea4a4-d33f-4be2-8a0f-20f2d14682d2
Version: 1
Effective Time: 20130116
 
BJWC (Berkley & Jensen / BJ's)