DOCUSATE SODIUM- docusate sodium capsule, liquid filled 
Blenheim Pharmacal, Inc.

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 -

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

Ask a doctor before use if you have

  • stomach pain, nausea or vomiting
  • have noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use
  • 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 to 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 red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special


Questions?

Adverse drug event call (800) 687-0176

Principal Display Panel

Blenheim Pharmacal, Inc.

NDC 10544-130-20

Docusate Sodium [Stool Softener] Softgel Capsules, 100mg

20 Softgel Capsules

100mg 20ct

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10544-130(NDC:66424-030)
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 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)  
Product Characteristics
Colorred (Two toned- white and clear red) Scoreno score
ShapeOVALSize5mm
FlavorImprint Code 51A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10544-130-2020 in 1 BOTTLE; Type 0: Not a Combination Product09/10/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/26/2013
Labeler - Blenheim Pharmacal, Inc. (171434587)
Registrant - Blenheim Pharmacal, Inc. (171434587)
Establishment
NameAddressID/FEIBusiness Operations
Blenheim Pharmacal, Inc.171434587repack(10544-130)

Revised: 3/2015
Document Id: 117c74e5-7084-543d-e054-00144ff88e88
Set id: 117c82a6-2063-566b-e054-00144ff88e88
Version: 2
Effective Time: 20150317
 
Blenheim Pharmacal, Inc.