STOOL SOFTENER- docusate sodium capsule, liquid filled 
CVS Pharmacy

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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CVS 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 over    take 1 to 3 capsules daily 
children 2 to under 12 years
   take 1 capsule daily 
children under 2 years

   ask 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
  • see end flap for expiration date and lot  number

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

CVS
Health™                   Compare to the active ingredient in Colace®*

NDC 59779-657-00

Stool
Softener
DOCUSATE SODIUM, 100 mg
Stool softener

Relieves constipation
• Gentle, reliable relief

10 SOFTGELS                           Actual Size

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    ORG111565703

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
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Product of China
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CVS 44-657

CVS 44-657

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-657
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorRED (Clear Red) , BROWN (Opaque Light Beige) Scoreno score
ShapeOVALSize13mm
FlavorImprint Code 657
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-657-031 in 1 CARTON03/01/201502/16/2016
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:59779-657-001 in 1 CARTON03/01/201512/07/2020
210 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:59779-657-0130 in 1 BOTTLE; Type 0: Not a Combination Product03/01/201507/08/2018
4NDC:59779-657-12100 in 1 BOTTLE; Type 0: Not a Combination Product03/01/201507/08/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33403/01/201512/07/2020
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd421293287API MANUFACTURE(59779-657)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(59779-657)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(59779-657)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(59779-657)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(59779-657)

Revised: 1/2018
Document Id: 1f6bd520-95f0-4860-ba2e-a7ea1e2cde7b
Set id: 4ef7e414-483f-4192-8361-08fbbd0cd653
Version: 6
Effective Time: 20180123
 
CVS Pharmacy