STOOL SOFTENER- docusate sodium capsule 
NORTHEAST PHARMA (Heartland Pharma)

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Drug Facts

Active Ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Purpose

Stool Softener Laxative

Uses

Warnings

Do not use

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

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

Stop use and ask a doctor if

  • you have rectal bleeding or no bowel movement after using laxative. These could be signs of a serious condition.
  • you need to use a 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

adults and children 12 years and overtake 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

Inactive Ingredients

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol

Questions or Comments ?

Call 1-800-383-0648

Principal Display Panel

Compare to active ingredient in COLACE®  REGULAR STRENGTH†

STOOL  SOFTENER

Docusate Sodium 100 mg

Stool Softener Laxative

Softgels

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. 

Distributed by NORTHEAST PHARMA

South Burlington, VT 05403

www.heartlandpharma.com

Product Label

Docusate Sodium 100 mg

HEARTLAND PHARMA Stool Softener

STOOL SOFTENER 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80136-951
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize12mm
FlavorImprint Code P51
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80136-951-80100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/28/202106/28/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00706/28/202106/28/2025
Labeler - NORTHEAST PHARMA (Heartland Pharma) (081232935)

Revised: 4/2024
Document Id: cd7b26e3-3c02-4d0a-aa69-4a62e20133fd
Set id: 35958471-f257-4432-997c-db60f04e62b8
Version: 3
Effective Time: 20240411
 
NORTHEAST PHARMA (Heartland Pharma)