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Stool Softener by P & L Development of New York Corporation

Medically reviewed on December 4, 2017

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: P & L Development of New York Corporation
NDC Code: 59726-005

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.

Gentle Relief Stool Softener

Active Ingredients (in each softgel)

Docusate Sodium 100mg

Purpose

Stool softener

Uses
  • temporary relief of occasional constipation.
  • This product generally produces a bowel movement within 12 to72 hours.

Warnings - Do not useif abdominal pain, nausea or vomiting are present

Ask a doctor before use if
  • you notice a sudden change in bowel habits that persists over a period of 2 weeks.
  • you are presently taking mineral oil

Stop use and ask a doctor if
  • rectal bleeding or failure to have bowel movement occur after use which may indicate a serious condition
  • you need to use a laxative for more than 1 week.

If pregnant or breastfeeding

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 immediately.

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

Other information
  • each softgel contains: sodium 6mg
  • store at controlled room temperature 15 - 30 degrees C (59-86 degrees F)
  • do not use if imprinted safety seal under cap is broken or missing.
  • *This product is not manufactured or distributed by Boehringer Ingelheim Consumer Healthcare, owner of the registered trademark Dulcolax.

Inactive Ingredients

edible ink, FDandC Red #40, FDandC Yellow #6, gelatin, glycerin, polyethylene, propylene glycol, purified water and sorbitol special.

Questions or comments?

call toll free: 1-877-753-3935

Comapre to the active ingredient in Dulcolax Stool Softener                      NDC: 59726-005-25

Gentle Relief

Stool Softener

Docusate Sodium 100mg

Fast, Dependable Relief of Occasional Constipation

25 softgels



Distributed by PL Development

Westbury, NY 11590 USA


Product Labeling

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-005
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 
HIGH DENSITY POLYETHYLENE 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
Colororange (ORANGE) Scoreno score
ShapeOVAL (OVAL) Size8mm
FlavorImprint CodeP51
Contains    
Packaging
#Item CodePackage Description
1NDC:59726-005-251 BOTTLE (BOTTLE) in 1 BOX
125 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33412/01/2011
Labeler - P & L Development of New York Corporation (800014821)

 
P & L Development of New York Corporation

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Further information

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

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