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Stool Softener by P & L Development, LLC

Medically reviewed on January 18, 2018

Dosage form: capsule
Ingredients: DOCUSATE SODIUM 100mg
Labeler: P & L Development, LLC
NDC Code: 59726-243

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
  • relieves occasional constipation (irregularily) 
  • generally produces a bowel movement in 12 to 72 hours

Warnings

Do not use

if you are presently taking a 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 thats 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 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 only by mouth. Doses may be taken as a single daily dose or in divided doses
adults and children 12 years and overtake 1-3 softgels daily 
children 2 to under 12 years of agetake 1 softgel daily 
children under 2 years ask a doctor 

Other information
  • each softgel contains: sodium 7 mg
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, medium-chain triglycerides*, polyethylene glycol, propylene glycol, purified water sorbitan, sorbitol

*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†

stool softener

docusate sodium 100 mg

stool softener laxative

  • gentle
  • effective
  • stimulant-free for comfortable relief

SOFTGELS

†This product id not manufactured or distributed by Purdue Products L.P., distributor of Colace® Stool Softener.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

Product Label

Readyincase Stool Softener

STOOL SOFTENER 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-243
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 
MEDIUM-CHAIN TRIGLYCERIDES 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize12mm
FlavorImprint CodeP51;S77;SCU1
Contains    
Packaging
#Item CodePackage Description
1NDC:59726-243-1212 BLISTER PACK in 1 CARTON
11 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33412/31/2015
Labeler - P & L Development, LLC (800014821)

 
P & L Development, LLC

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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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