Skip to Content

← See all Docusate Sodium brands

Docusate Sodium by Pharbest Pharmaceuticals, Inc.

Dosage form: capsule
Ingredients: Docusate Sodium 100mg
Labeler: Pharbest Pharmaceuticals, Inc.
NDC Code: 16103-384

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.

Drug Facts

Active ingredient (in each softgel)Docusate sodium 100 mg


Purpose

Stool softener

Uses
  • prevents/relieves dry hard stool
  • results usually occurs 1 to 3 days after the first dose

Warnings

Do not use
  • when abdominal pain, nausea, or vomiting are present
  • for more than one week unless directed by a doctor

Ask a doctor before use if you
  • are taking mineral oil
  • have noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if
  • you have no bowel movement after 3 days
  • you have rectal bleeding
These could be signs of a serious condition

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
  • do not exceed recommended dose
adults and children over 12 years                        
take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter
children 6 to 12 years
take 1 softgel daily
children under 6 years
consult a doctor

Other information
  • Tamper Evident: Do not use if safety seal under cap is broken or missing
  • store at room temperature 15o to 30oC (59o to 86oF)
  • protect from moisture

Inactive ingredients: D&C yellow #10, FD&C red #40, gelatin, glycerin, ink white, polyethylene glycol, sorbitol, propylene glycol.

Questions?

Adverse drug event call: (866) 562-2756

Principal Display Panel

*Compare to the active ingredient of Colace®

Docusate Sodium

Stool Softener

1000 SOFTGELS

100 mg each

DOCUSATE SODIUM 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-384
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Docusate Sodium (Docusate) Docusate Sodium100 mg
Inactive Ingredients
Ingredient NameStrength
D&C Yellow No. 10 
FD&C Red No. 40 
Gelatin 
Glycerin 
Polyethylene Glycol 
Propylene Glycol 
Sorbitol 
Product Characteristics
Colorred (Two-toned- white and clear red) Scoreno score
ShapeOVALSize5mm
FlavorImprint Code51A
Contains    
Packaging
#Item CodePackage Description
1NDC:16103-384-08100 CAPSULE (CAPSULE) in 1 BOTTLE
2NDC:16103-384-111000 CAPSULE (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/22/2007
Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIOperations
Pharbest Pharmaceuticals, Inc557054835repack
Establishment
NameAddressID/FEIOperations
Accucaps Industries Ltd.248441727manufacture

 
Pharbest Pharmaceuticals, Inc.

← See all Docusate Sodium brands

Medically reviewed on Jul 6, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide