DOCUSATE SODIUM- docusate sodium capsule, liquid filled 
McKesson Corporation

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 capsule)

Docusate Sodium 100mg

Purpose

Stool Softener

Uses

Warnings

Do not use

Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if

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

Other information

Inactive ingredients

FD&C red #40, gelatin, glycerin, polyethylene glycol, propyleneglycol and sorbitol special. May also contain: D&C yellow #10, FC&C yellow #6 and purified water.

HOW SUPPLIED

Product: 63739-478

Docusate Sodium

Label Image

mckessondsslabel.jpg

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63739-478(NDC:61301-8001)
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)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorred (Reddish) Scoreno score
ShapeOVALSize12mm
FlavorImprint Code SCU1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63739-478-0125 in 1 BOX, UNIT-DOSE11/09/201002/28/2016
130 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:63739-478-1010 in 1 BOX, UNIT-DOSE11/09/201002/28/2016
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:63739-478-481000 in 1 BOTTLE; Type 0: Not a Combination Product09/19/201709/21/2017
4NDC:63739-478-40100 in 1 BOTTLE; Type 0: Not a Combination Product09/19/201709/21/2017
5NDC:63739-478-0230 in 1 BOX, UNIT-DOSE07/01/2021
510 in 1 BLISTER PACK; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33411/09/2010
Labeler - McKesson Corporation (140529962)
Establishment
NameAddressID/FEIBusiness Operations
Contract Packaging Resources Inc.960203917repack(63739-478)

Revised: 8/2021
Document Id: ca3f4d9b-3ee9-3040-e053-2995a90a4a82
Set id: 48555cc1-a711-411f-a384-550116da1d3c
Version: 8
Effective Time: 20210823
 
McKesson Corporation