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Stool Softener by P & L Development of New York Corporation

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE CALCIUM 240mg
Labeler: P & L Development of New York Corporation
NDC Code: 59726-170

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.

Sodium Free Stool Softener

Active Ingredient (in each softgel)

Docusate Calcium 240mg

Purpose

Stool softener

Uses

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

Warnings - Do not use
  • if  you are currently taking mineral oil, unless directed by a doctor
  • when abdominal pain, nausea, or vomiting are present
  • for longer than 1 week, unless directed by a doctor.

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

Stop use and ask a doctor if
  • you have rectal bleeding
  • you fail to have a bowel movement after use

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 right away.

Directions
  • adults and children over 12 years of age: take 1 softgel daily for several days, or until bowel movements are normal, or as directed by a doctor.
  • children under 12 years of age: take as directed by a doctor.

Other information
  • store at controlled room temperature 15 - 20 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 Chattem, Inc., owner of the registered trademark Surfak Stool Softener.

Inactive Ingredients

corn oil, DandC Red #33, edible white ink, FDandC Red #40, gelating, glycerin, purified water and sorbitol special.

Questions or comments?

call toll free: 1-877-753-3935

8Comapre to the active ingredient in Surfak Stool Softener                      NDC: 59726-170-01

Sodium Free

Stool Softener

Docusate Calcium 240mg

Gentle Relief of Constipation

100 softgels



Distributed by PL Development

Westbury, NY 11590 USA


Product Labeling

STOOL SOFTENER 
docusate calcium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-170
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE CALCIUM (DOCUSATE) DOCUSATE CALCIUM240 mg
Inactive Ingredients
Ingredient NameStrength
CORN OIL 
D&C RED NO. 33 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
WATER 
SORBITOL 
Product Characteristics
Colorred (RED) Scoreno score
ShapeOVAL (OVAL) Size8mm
FlavorImprint CodeP58
Contains    
Packaging
#Item CodePackage Description
1NDC:59726-170-01100 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)

Revised: 12/2011
 
P & L Development of New York Corporation

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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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