Docusate Sodium 100mg by Pharmaceutica North America, Inc. / Pure Source, LLC

Docusate Sodium 100mg by

Drug Labeling and Warnings

Docusate Sodium 100mg by is a Otc medication manufactured, distributed, or labeled by Pharmaceutica North America, Inc., Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOCUSATE SODIUM 100MG- docusate sodium capsule 
Pharmaceutica North America, Inc.

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Active Ingredient

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 12 to 72 hours

Warnings

Do not use
if you are presently taking mineral oil, unless told to do so by a doctor.
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 care 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 softgels daily
 children 2 to under 12 years of age take 1 softgel daily
 children under 2 years ask a doctor

Other information

each softgel contains: sodium 7 mg
store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)

Inactive Ingredients

citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink

Questions or comments? 1-888-788-6472

Product label

image description

DOCUSATE SODIUM 100MG 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 45861-076
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)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize13mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 45861-076-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/01/202512/31/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00702/01/202512/31/2025
Labeler - Pharmaceutica North America, Inc. (962739699)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, LLC080354456manufacture(45861-076)

Revised: 12/2025