DOCUSATE SODIUM- docusate sodium capsule, liquid filled 
Marlex Pharmaceuticals 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

DOCUSATE SODIUM- docusate sodium capsule Marlex Pharmaceuticals, 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 100 mg

Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

Warnings

Do not use

if you are presently taking mineral oil, unless directed 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

Ask a doctor or pharmacist before use if you are

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative.
  • you need to use stool softner laxative for more than 1 week

These could be sings 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

adults and children 12 years and overtake 1 - 3 softgels once daily or in divded doses
children 2 to under 12 years of age1 softgel once daily
children under 2 yearsask a doctor

Other informaiton

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400 NF, purified water, sorbitol

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

*Marlex Pharmaceuticals, Inc., is not affiliated with the owner of the trademark Colace®

Distributed by:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720

Made in Romania

PRINCIPAL DISPLAY PANEL

NDC 10135-0111-01
Docusate Sodium
100 mg

100
Softgels

PRINCIPAL DISPLAY PANEL
NDC 10135-0111-01
Docusate Sodium
100 mg
100 Softgels

PRINCIPAL DISPLAY PANEL
NDC 10135-0111-01
Docusate Sodium
100 mg
100 Softgels

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-111
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 400 (UNII: B697894SGQ)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize13mm
FlavorImprint Code SCU1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10135-111-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/01/2017
Labeler - Marlex Pharmaceuticals Inc (782540215)

Revised: 10/2021
Document Id: cf1c9490-28f8-67f3-e053-2a95a90a7524
Set id: c34e6f3d-9a11-4164-a26c-1ef62513c184
Version: 4
Effective Time: 20211024
 
Marlex Pharmaceuticals Inc