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STOOL SOFTENER by PuraCap Pharmaceutical LLC

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: PuraCap Pharmaceutical LLC
NDC Code: 51013-122

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.

STOOL SOFTENER

Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener

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 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
  • 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 to 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 5 mg
  • VERY LOW SODIUM
  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat 

Inactive ingredients

D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special, citric acid, purified water and black edible ink

Questions or comments?

Call toll free: 1-800-833-6278

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DISCOUNT drug mart STOOL SOFTENER 

DOCUSATE SODIUM 100mg  250 SOFTGELS

Compare to the active ingredient in COLACE®

NDC 51013-122-27

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-122
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
Colorred, white (Two-Tone) Scoreno score
Shapecapsule (Oval) Size13mm
FlavorImprint CodePC18
Contains    
Packaging
#Item CodePackage Description
1NDC:51013-122-27250 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/30/2016
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(51013-122), analysis(51013-122)

Revised: 06/2016
 
PuraCap Pharmaceutical LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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