DOCUSATE SODIUM - docusate sodium capsule 
Sam's West 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

Ask a doctor before use if you have

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 (1-800-222-1222) right away.

Directions

Take only by mouth. Doses may be taken as a single daily dose or in divided doses.


adults and children 12 years and over
take 1-3 softgel 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 No.33, gelatin, glycerin, Neelicert FD&C Red No.40, Neelicert FD&C Yellow No.6, noncrystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, shellac glaze, titanium dioxide.

Questions or Comments?

Call 1-855-274-4122 (toll-free)

(Monday - Friday 8:30 AM to 5:00 PM EST)


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


DISTRIBUTED BY
SAM'S WEST, INC.
BENTONVILLE, AR 72716

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg (600 Capsules Container Label)

Compare to Colace®
active ingredient*

NDC 68196-995-64


Member's Mark

Stool
Softener

Docusate sodium 100 mg

Regular Strength

600 Softgels
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg (600 Capsules Container Label)

DOCUSATE SODIUM 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-995
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)  
GELATIN TYPE B BOVINE (160 BLOOM) (UNII: 1T8387508X)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorREDScoreno score
ShapeOVALSize13mm
FlavorImprint Code Q04
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68196-995-64600 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33402/08/2018
Labeler - Sam's West Inc (051957769)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777MANUFACTURE(68196-995)

Revised: 12/2020
Document Id: eac8782d-f58e-481d-9409-619a2b439795
Set id: b0e99ebb-41fc-459f-86d2-f0e3527f97b0
Version: 3
Effective Time: 20201209
 
Sam's West Inc