DOCUSATE SODIUM- docusate sodium capsule, liquid filled 
Precision Dose, Inc.

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.

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Docusate Sodium capsule

Drug Facts

Active ingredient (in each softgel)

Docusate sodium 250 mg

Purpose

Stool softener laxative

Uses

  • for the prevention of dry, hard stools
  • for relief of occasional constipation
  • this product generally produces a bowel movement within 12 to 72 hours

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
  • 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 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

  • Use as directed per healthcare professional.
  • adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
  • children under 12 years of age: ask a doctor

Other information

  • each softgel contains: sodium 15 mg
  • store between 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F)

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special

Questions or comments

1-800-397-9228

Distributed by:
Precision Dose, Inc.
South Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 250 mg Softgel Blister Pack Carton

PrecisionDose™

Extra Strength
Docusate Sodium
250 mg Softgels

100 Softgels
(10x10)

Hospital Use Only
NDC 68094-025-61

PRINCIPAL DISPLAY PANEL - 250 mg Softgel Blister Pack Carton
DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-025
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Docusate Sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate Sodium250 mg
Inactive Ingredients
Ingredient NameStrength
FD&C Red No. 40 (UNII: WZB9127XOA)  
FD&C Yellow No. 6 (UNII: H77VEI93A8)  
Gelatin, Unspecified (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
ShapeCAPSULESize20mm
FlavorImprint Code P20;SCU1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68094-025-6110 in 1 CARTON05/23/201903/31/2021
1NDC:68094-025-5910 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33405/23/201903/31/2021
Labeler - Precision Dose, Inc. (035886746)
Establishment
NameAddressID/FEIBusiness Operations
Precision Dose, Inc.035886746REPACK(68094-025)
Establishment
NameAddressID/FEIBusiness Operations
SWISSCAPS Romania srl565466997MANUFACTURE(68094-025)

Revised: 2/2021
Document Id: eafb6512-a0fd-4e99-81c7-c15ca9766f5e
Set id: bdffa450-921c-4992-968e-1835ea1b50a1
Version: 3
Effective Time: 20210201
 
Precision Dose, Inc.