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Stool Softener by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
NDC Code: 55910-583

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.

Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses
  • for temporary relief of occasional constipation and irregularity 
  • this product generally produces bowel movement in 12 to 72 hours

Warnings

Ask a doctor before use if you have
  • stomach pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

Ask a doctor or pharmacist before use if you are

presently taking mineral oil.

Stop use and ask a doctor if
  • you have rectal bleeding or no bowel movement after using a laxative. These could be sign of a serious condition.
  • you need to use a laxative for more than 1 week

If pregnant or breast-feeding,

ask a health care 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 with a glass of water
 adults and children 12 years and over take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
 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 25ºC (77º); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water sorbitan,sorbitol

*contains one or more of these ingredients

Questions or comments?

Call toll free 1-866-4-REXALL

Principal Display Panel

Stool Softener

DOCUSATE SODIUM, 100 mg

Stool softener Laxative

Stimulant free

SOFTGELS

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

Packaged for Dolgencorp, LLC

100 Mission ridge

Goodlettsville, TN

37072 USA

Product Label

Rexall Stool Softener Softgels

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-583
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 
WATER 
SORBITOL 
SORBITAN 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize12mm
FlavorImprint CodeP51;SCU1;D2
Contains    
Packaging
#Item CodePackage Description
1NDC:55910-583-20200 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33410/01/2017
Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)

 
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

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Medically reviewed on Nov 22, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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