Your browser does not support JavaScript! STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [WALGREEN CO.]
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STOOL SOFTENER (docusate sodium) capsule, liquid filled
[WALGREEN CO.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredient (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 mouith.  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 yellow #10, edible white ink, FD&C red #40, gelatin, glycerine, polyethylene glycol, propylene glycol, sorbitol 

Questions or comments?

1-800-426-9391

Principal display panel

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ

NDC 0363-0351-56

STOOL SOFTENER
Gentle
Laxative
Docusate Sodium USP 100 mg 
• Gentle & easy relief of occasional constipation

25
LIQUID GELS

Compare to Dulcolax® Stool Softener Liquid Gels active ingredientǂǂ

ǂWalgreens Pharmacist Survey Study, November 2012.
ǂǂThis product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., owner of the registered trademark Dulcolax® Stool Softener Liquid Gels.
50844    REV0712B35156

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

Walgreens 44-351

Walgreens 44-351


STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-0351
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C RED NO. 40 
GLYCERIN 
GELATIN 
PROPYLENE GLYCOL 
SORBITOL 
Product Characteristics
ColorREDScoreno score
ShapeCAPSULESize13mm
FlavorImprint Code A92
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0351-561 in 1 CARTON
125 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33409/21/1995
Labeler - WALGREEN CO. (008965063)
Establishment
NameAddressID/FEIBusiness Operations
Accucaps Industries, Ltd.248441727MANUFACTURE(0363-0351)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(0363-0351)

Revised: 7/2013
 
WALGREEN CO.

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