DOCUSATE SODIUM- docusate sodium  capsule, liquid filled 
Akron Pharma 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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Drug Facts

Active ingredient

(in each capsule)----------- 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 currently taking mineral oil, unless directed by a doctor

Ask a doctor before use if you have

  • stomach pain, nausea or vomiting
  • noticed a sudden change in bowel habits that lasts over two weeks

Stop use and ask a doctor if

  • you have rectal bleeding
  • you 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 one 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

adults and children 12 years and over                         take 1-3 capsules once daily or in divided doses 
children 6 years to under 12 yearstake 1 capsule once daily
children under 6 yearsask a doctor

Other information

  • each capsule contains sodium 7 mg
  • store at room temperature 15o-30oC (59o-86oF) in a dry place

Inactive ingredients: FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400, purified water and sorbitol


Questions?

Call +1(877) 255-6999, 8:30am - 4:30pm EST Monday - Friday

*Akron Pharma Inc is not affiliated with the owner of trademark Colace

Manufactured for:

Akron Pharma, Inc.
Fairfield, NJ 07004


Manufactured in U.S.A

label

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-8020
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
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71399-8020-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/20/202001/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33411/20/202001/25/2022
Labeler - Akron Pharma Inc. (067878881)

Revised: 1/2022
Document Id: d52fb599-362a-44fc-85d0-caa1b3c424d9
Set id: 2a5f5ec9-c555-40a2-9d7c-cd491969fbc5
Version: 2
Effective Time: 20220123
 
Akron Pharma Inc.