Sodium Free Stool Softener

Stool Softener by

Drug Labeling and Warnings

Stool Softener by is a Otc medication manufactured, distributed, or labeled by P & L Development of New York Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STOOL SOFTENER- docusate calcium capsule, liquid filled 
P & L Development, LLC

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.

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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
STOOL SOFTENER 
docusate calcium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59726-170
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG) DOCUSATE CALCIUM240 mg
Inactive Ingredients
Ingredient NameStrength
CORN OIL (UNII: 8470G57WFM)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorRED (RED) Scoreno score
ShapeOVAL (OVAL) Size8mm
FlavorImprint Code P58
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59726-170-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/01/201112/30/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33412/01/201112/30/2016
Labeler - P & L Development, LLC (800014821)

Revised: 1/2020
Document Id: 7f769c1d-4dfd-477d-acca-0c177cf1e053
Set id: 68c6cc1d-2977-4c3b-9072-a86f0a2688d7
Version: 2
Effective Time: 20200121
 
P & L Development, LLC