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

Medically reviewed on Oct 26, 2016

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: L.N.K. International, Inc.
NDC Code: 50844-655

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 44-655

Active ingredient (in each liquid-filled capsule)

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 bowl habits that lasts over 2 weeks

Stop use and ask a doctor if
  • you have rectal bleeding or fail to have a bowl 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 with a glass of water 
  • take only by mouth. Doses may be taken as a single daily dose or in divided doses.
adults and children 12 years and overtake 1 to 3 capsules daily
 children 2 to under 12 years of agetake 1 capsule daily 
children under 2 years of age ask a doctor 

Other information
  • each capsule contains: sodium 6 mg 
    Very Low Sodium
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from excessive humidity
  • see end flap for expiration date and lot number 

Inactive ingredients

citric acid, edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, mineral oil, polyethyene glycol,
propylene glycol, purified water, sorbitol

Questions or comments?

1-800-426-9391

Principal display panel

Quality 
+ Plus

NDC 50844-655-56

*Compare to active ingredient in
Dulcolax® Stool Softener 

STOOL SOFTENER 

Docusate Sodium 100 mg
STOOL SOFTENER LAXATIVE

Comfortable, Stimulant-Free
Constipation Relief

25 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
Boehringer Ingelheim Pharmaceuticals, Inc., owner of 
the registered trademark Dulcolax® Stool Softener.

50844    ORG011565556

Product of China
Packaged and Quality Assured in the USA

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

Quality Plus 44-655

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-655
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
MINERAL OIL 
PROPYLENE GLYCOL 
SORBITOL 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize13mm
FlavorImprint Code655
Contains    
Packaging
#Item CodePackage Description
1NDC:50844-655-561 BOTTLE in 1 CARTON
125 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33403/01/2015
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIOperations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd421293287API MANUFACTURE(50844-655)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(50844-655)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(50844-655)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(50844-655)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(50844-655)

 
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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