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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Drug Facts

Active ingredient (in each softgel)

Docusate calcium 240 ​mg

Purpose

Stool softener laxative

Uses

Warnings

Do not use

if you are currently taking mineral oil, unless directed by a doctor.

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that 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 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

Other information

Inactive ingredients

corn oil, D&C red #33*, edible white ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6*, gelatin, glycerin, purified water, sorbitol special

*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 Surfak®† 

Stool Softener

Docusate calcium 240 mg

Gentle Relief of Constipation

Take once a day

Softgels

†This product is not manufactured or distributed by Chattem, Inc., distributor of Surfak®.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

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

Product Label

Docusate calcium 240 mg

ReadyInCase Stool Softener Softgel

STOOL SOFTENER 
docusate calcium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-257
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 BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorREDScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code P58;SCU
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-257-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33404/30/2014
Labeler - P & L Development, LLC (800014821)

Revised: 12/2019
Document Id: 74ab2a14-07ba-4f90-8b98-19b92a3a97aa
Set id: 7a855947-78b6-4e89-a289-65e0c8bbbbb3
Version: 3
Effective Time: 20191205
 
P & L Development, LLC