STOOL SOFTENER- docusate sodium 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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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 use

if 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

Stool Softener
STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorORANGE (ORANGE) Scoreno score
ShapeOVAL (OVAL) Size8mm
FlavorImprint Code P51
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-005-251 in 1 BOX12/01/201112/30/2016
125 in 1 BOTTLE; Type 0: Not a Combination Product
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: aab67493-3be2-40b7-9e09-3682275fdad8
Set id: 526f795c-ab22-429b-8a68-7d9ca6c9c8ad
Version: 2
Effective Time: 20200123
 
P & L Development, LLC