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Stool Softener by Velocity Pharma

Medically reviewed on May 11, 2018

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Velocity Pharma
NDC Code: 76168-069

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.

Docusate Sodium, USP 100mg

Active Ingredient

(in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Uses
  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 12 to 72 hours

Warnings

Ask a doctor before use if you have:

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

Ask a doctor or pharmacist before use if you are presently taking mineral oil.

Stop use and ask a doctor if:

  • you have rectal bleeding or no bowel movement after using this product. This could be signs of a serious condition.
  • you need to use 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 with glass of water

adults and children 12 years and over:

  • 1 to 3 liquid gels daily. This dose may be taken as single daily dose or in divided doses.

    Children under 12 years of age:

  • 1 liquid gel daily

Children under 2 years of age

Ask a doctor

Other Information
  • store at 15-30 °C (59-86 °F)
  • protect from excessive humidity
  • do not use this product if the safety seal under the cap is torn or missing

Inactive Ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sorbitol special, titanium dioxide

Questions or Comments

Call 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 076168-069-05 – 25 COUNT

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-069
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
HYPROMELLOSES 
PROPYLENE GLYCOL 
SORBITOL 
TITANIUM DIOXIDE 
WATER 
GLYCERIN 
Product Characteristics
ColorREDScoreno score
ShapeOVALSize5mm
FlavorImprint CodeV100
Contains    
Packaging
#Item CodePackage Description
1NDC:76168-069-0525 CARTON (CAPSULE) in 1 BOTTLE
11 CAPSULE, LIQUID FILLED (BOTTLE) in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/01/2013
Labeler - Velocity Pharma (962198409)

 
Velocity Pharma

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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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