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Stool Softener by WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

Medically reviewed on August 28, 2017

Dosage form: capsule, gelatin coated
Ingredients: DOCUSATE SODIUM 100mg
Labeler: WOONSOCKET PRESCRIPTION CENTER,INCORPORATED
NDC Code: 59779-626

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.

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

STOOL SOFTENER 
docusate sodium capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-626
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 
POLYETHYLENE GLYCOLS 
GELATIN 
GLYCERIN 
PROPYLENE GLYCOL 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorRED (red and beige) Scoreno score
ShapeCAPSULESize12mm
FlavorImprint Code51A
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-626-0130 CAPSULE, GELATIN COATED in 1 BOTTLE
2NDC:59779-626-05400 CAPSULE, GELATIN COATED in 1 BOTTLE
3NDC:59779-626-12100 CAPSULE, GELATIN COATED in 1 BOTTLE
4NDC:59779-626-13250 CAPSULE, GELATIN COATED in 1 BOTTLE
5NDC:59779-626-58750 CAPSULE, GELATIN COATED in 1 BOTTLE
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/FEIOperations
Accucaps Industries, Ltd.248441727MANUFACTURE(59779-626)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(59779-626)

 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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