STOOL SOFTENER- docusate sodium capsule, liquid filled 
Harmon Store 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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Core Values 44-657

Active ingredient (in each liquid-filled 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 presently taking mineral oil, unless told 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

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 (1-800-222-1222) right away.

Directions

  • take only by mouth. Doses may be taken as a single daily dose or in divided doses.
  • take with a glass of water
adults and children 12 years and overtake 1 to 3 capsules daily
children 2 to under 12 yearstake 1 capsule daily
children under 2 yearsask a doctor


Other information

  • each capsule contains: sodium 6 mg
    Very Low Sodium
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from excessive humidity
  • use by expiration date on package

Inactive ingredients

citric acid, D&C red #33, edible black ink, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, propylene glycol, purified water, sorbitol, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

Core Values™

Compare to active ingredient
in Colace®†

NDC 63940-657-12

Stool Softener
Docusate sodium 100 mg 
Stool softener

Gentle & Effective

Stimulant-Free
for Comfortable Relief 

Actual Size

100 soft liquid-filled capsules 

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

†This product is not manufactured or distributed by Purdue Products
L.P., owner of the registered trademark Colace®.   50844   ORG111565712

Product of China, Packaged and Quality Assured in the USA

Distributed by: Liberty Procurement, Inc.,
650 Liberty Ave., Union, NJ 07083 U.S.A.
Satisfaction Guaranteed Or Your Money Back
Visit us at www.facevalues.com

Core Values L-657

Core Values L-657

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-657
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 BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorRED (clear red) , WHITEScoreno score
ShapeOVALSize13mm
FlavorImprint Code 657
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63940-657-12100 in 1 BOTTLE; Type 0: Not a Combination Product03/01/201507/22/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33403/01/201507/22/2022
Labeler - Harmon Store Inc. (804085293)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(63940-657)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(63940-657)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(63940-657)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(63940-657)

Revised: 8/2019
Document Id: 7c1f6213-b177-4516-a009-7128aaa6d6d6
Set id: a270e33f-fba8-4e8c-a471-361941b9b0d9
Version: 5
Effective Time: 20190816
 
Harmon Store Inc.