FAMILY WELLNESS STOOL SOFTENER  - docusate sodium capsule, liquid filled 
P & L Development of New York Corporation

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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Active Ingredients (in each softgel)

Docusate Sodium 100mg

Purpose

Stool softener

Uses

Warnings - Do not use

if you are presently taking mineral oil, unless told to do so 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 stool softener 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

Take only by mouth. Doses may be taken as a single daily does or in divided doses.

Other information

Inactive Ingredients

DandC Red #33, edible ink, FDandC Blue #1, FDandC Red #40, FDandC Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special and titanium dioxide.

Questions or comments?

call toll free: 1-877-753-3935

Comapre to the active ingredient Colace                 NDC: 59726-001-01

Family Wellnes

Stool Softener

Docusate Sodium 100mg

Relieves Constipation
Safe, Gentle, Reliable
100 Softgels


Distributed by PL Development

Westbury, NY 11590 USA


Product Labeling

Stool Softener


FAMILY WELLNESS STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-001
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
Colorred (RED) , white (WHITE) Score no score
ShapeOVAL (OVAL) Size8mm
FlavorImprint Code P10
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:59726-001-01100 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33412/01/201112/06/2011

Labeler - P & L Development of New York Corporation (800014821)

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