DOCUSATE SODIUM- docusate sodium capsule, liquid filled 
Spirit Pharmaceuticals LLC

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STOOL SOFTENER

Drug Facts

Active ingredient (in each gelcaps)

Docusate Sodium 100 mg 

Purpose

Stool Softner

Uses

Do not use

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

When abdominal pain, nausea, or vomiting are present for longer than 1 week unless directed by a doctor

Ask a doctor before use if you

notice a sudden change in bowel habits that persists over a period of 2 weeks

Stop use abd ask a doctor if you

have rectal bleeding fail to have a bowel movement occur after use.

If pregnant or breast-feeding 

ask a health professional before use

Keep out of reach of children

In case of accidental overdose, get medical help or contact a Poison Control Center 1(800)222-1222 immediately.

Stop use and ask a doctor if you

have rectal bleeding fail to have bowel movement occur after use.

If pregnant or breast feeding 

Ask a health professional before use 

Keep out of reach of children

In case of accidental overdose, get medical help or contact a Poison Control Center 1-800-222-1222 immediately.

Directions

Other information

Inactive ingredients

FD&C Red #33, FD&C Red#40, FD&C Yellow#6, gelatin,

glycerin, polyethylene glycol 400, propylene glycol, purified

water, shellac, sorbitol solution, titanium dioxide.

Questions or comments?

1-888-333-9792

PRICNIPAL DISPLAY PANEL

Compare to the active ingredient in

Colace ® Gel Caps *

STOOL

SOFTENER

DOCUSATE SODIUM 100 mg

Gentle

Effective

Stimulant-Free Relief

100 GELCAPS

Docusate 100 mg 100ct

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0350
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
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
WATER (UNII: 059QF0KO0R)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite, redScoreno score
ShapeCAPSULESize12mm
FlavorImprint Code 413
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-0350-11 in 1 CARTON03/10/2020
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00703/10/2020
Labeler - Spirit Pharmaceuticals LLC (179621011)

Revised: 12/2023
Document Id: 0c05770e-40d3-fb46-e063-6294a90a64ab
Set id: 69ca6847-bb21-4b16-917e-caf7fe98a5f8
Version: 5
Effective Time: 20231208
 
Spirit Pharmaceuticals LLC