STOOL SOFTENER- docusate sodium capsule, gelatin coated 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

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 44-626-Delisted

Active ingredients (in each liquid gel)

Docusate sodium 100 mg 

Purpose

Stool softener laxative 

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 liquid gels
daily 
children 2 to under
12 years of age		take 1 liquid gel daily 
children under
2 years of age 		ask a doctor 

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from excessive humidity
  • use by expiration date on package 

Inactive ingredients

D&C red #33, D&C yellow #6, edible black ink, FD&C red #40, gelatin, glycerine, polyethylene glycol, propylene glycol, sorbitol, titanium dioxide 

Questions or comments?

1-800-426-9391

Principal Display Panel

CVS
pharmacy®

Compare to the active ingredient in Colace® Stool Softener*

STOOL
SOFTENER
DOCUSATE SODIUM 100 mg

RELIEVES CONSTIPATION 
• Gentle stool softener
• Reliable relief
• Stimulant free

100 Liquid Gels

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    ORG031362612

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2013 CVS/pharmacy
www.cvs.com    1-800-shop-CVS

Product of Canada
V-14236
CVS 44-626

CVS 44-626

STOOL SOFTENER 
docusate sodium capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-626
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)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorRED (red and beige) Scoreno score
ShapeCAPSULESize12mm
FlavorImprint Code 51A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-626-0130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:59779-626-05400 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:59779-626-12100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:59779-626-13250 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:59779-626-58750 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33404/22/201308/27/2018
Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)
Establishment
NameAddressID/FEIBusiness Operations
Accucaps Industries, Ltd.248441727MANUFACTURE(59779-626)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(59779-626)

Revised: 8/2015
Document Id: 43b04623-f000-4efb-88b9-f7f56fd99ede
Set id: 5e4954ea-2328-4ce9-ab68-7e76ab6a98ef
Version: 3
Effective Time: 20150827
 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED