Your browser does not support JavaScript! STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]
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RxNorm Names

STOOL SOFTENER (docusate sodium) capsule, liquid filled
[TOP CARE (Topco Associates LLC)]


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 softgel)

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 stool softener 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

  •  Take only by mouth. Doses may be taken as a single daily dose or in divided doses.
 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

  • each softgel contains: sodium 6 mg
  • store at controlled room temperature 15°-30°C (59°-86°F)

Inactive ingredients

D&C Red #33, edible ink, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, and titanium dioxide

Questions or comments?

1-888-423-0139

Principal Display Panel

SAFE, GENTLE & RELIABLE

Stool Softener

Docusate Sodium, 100 mg

Relieves Constipation

COMPARE TO COLACE® active ingreident*

SOFTGELS 100 mg EACH

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

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

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL  60007

topcare@topco.com

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Package Label

TopCare

Docusate Sodium 100 mg

 

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-111
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
SORBITOL 
D&C RED NO. 33 
TITANIUM DIOXIDE 
FD&C BLUE NO. 1 
WATER 
SORBITAN 
Product Characteristics
ColorRED, WHITEScoreno score
ShapeOVALSize13mm
FlavorImprint Code P10;51A
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-111-061 in 1 BOX
160 in 1 BOTTLE
2NDC:36800-111-01100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33407/01/2010
Labeler - TOP CARE (Topco Associates LLC) (006935977)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 12/2012
Document Id: 54c4f5d1-19b3-4ffe-9ff6-a2ebd6f226d1
Set id: 06963744-e4d4-431a-8c1a-fad654875da2
Version: 3
Effective Time: 20121227
 
TOP CARE (Topco Associates LLC)

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