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Stool Softener by L.N.K. International, Inc.

Medically reviewed on August 28, 2017

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: L.N.K. International, Inc.
NDC Code: 50844-626

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.

Quality Plus 44-626-Delisted

Active ingredient (in each liquid gel)

Docusate sodium 100 mg 

Purpose

Stool softener
laxative 

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours 

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 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 (1-800-222-1222) right away. 

Directions
  • take only by mouth. Doses may be taken as a single daily dose or in divided doses.
  • take with a glass of water
 adults and children
 12 years and over
 take 1 to 3 liquid
 gels daily
 children 2 to under
 12 years of age
 take 1 liquid gel
 daily
 children under
 2 years of age
 ask a doctor

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from excessive humidity
  • use by expiration date on package

Inactive ingredients

D&C red #33, D&C yellow #6, edible black ink, FD&C red #40, gelatin, glycerine, polyethylene glycol, propylene glycol, sorbitol, titanium dioxide

Questions or comments?

 1-800-426-9391

Principal Display Panel

QUALITY
PLUS

NDC 50844-626-08

*Compare to the active
ingredient in Colace®

Stool Softener

Docusate sodium, 100 mg
Stool Softener Laxative
Gentle
Effective
Stimulant-Free
For Comfortable Relief

24 Liquid Gels

Actual Size

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

*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.
50844      ORG031362608

Distributed by: LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788 USA
Product of Canada 

Quality Plus 44-626

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-626
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 RED NO. 40 
GELATIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeOVALSize12mm
FlavorImprint Code51A
Contains    
Packaging
#Item CodePackage Description
1NDC:50844-626-0824 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33404/22/201308/27/2018
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(50844-626)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(50844-626)

 
L.N.K. International, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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