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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Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

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 right away.

Directions

 adults and children 12 years and over  take 1-3 softgels daily
 children 2 to under 12 years of age take 1 softgel daily
 children under 2 years ask a doctor

Other information

Inactive ingredients

D&C red #33*, D&C yellow #10*, edible ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin*, medium-chain triglycerides*, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Colace® †

Stool Softener

Relieves Constipation

Docusate Sodium 100 mg

SOFTGELS

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2013 CVS/ Pharmacy

CVS.com 1-800-SHOP-CVS

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

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

Product Labeling

CVS Pharmacy

Docusate Sodium 100 mg softgels

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-038
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 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
EGG PHOSPHOLIPIDS 
MEDIUM-CHAIN TRIGLYCERIDES 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SORBITAN 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorRED, WHITEScoreno score
ShapeOVALSize12mm
FlavorImprint Code P10;S78;SCU2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-038-01100 in 1 BOTTLE
2NDC:59779-038-0330 in 1 BOTTLE
3NDC:59779-038-25250 in 1 BOTTLE
4NDC:59779-038-3636 in 1 BOTTLE
5NDC:59779-038-40400 in 1 BOTTLE
6NDC:59779-038-75750 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33407/30/2013
Labeler - CVS Pharmacy (062312574)

Revised: 9/2013
Document Id: 2fcec747-b9b4-45a3-81ea-305ae14e0981
Set id: 7ce7a762-68c2-4f29-92aa-b3a02334e71b
Version: 1
Effective Time: 20130918
 
CVS Pharmacy