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Stool Softener by Better Living Brands, LLC

Medically reviewed on June 29, 2018

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Better Living Brands, LLC
NDC Code: 21130-655

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.

Signature Care 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 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 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
take 1 capsule daily
children under 2 years of ageask 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

anhydrous citric acid, edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol

Questions or comments?

1-800-426-9391 

Principal Display Panel

Signature
care

Quality Guaranteed

COMPARE TO
DulcoEase® Stool Softener
active ingredient*

NDC 21130-655-56

Stool Softener

DOCUSATE SODIUM 100 mg
Stool Softener Laxative

• Gentle
• Effective
• Stimulant-free
  for comfortable relief

Actual Size

25 LIQUID GELS

OUR PROMISE
QUALITY & SATISFACTION
100% GUARANTEED
OR YOUR MONEY BACK.

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

DISTRIBUTED BY BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-723-3929   www.betterlivingbrandsLLC.com

*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributors of DulcoEase® Stool Softener.
50844     REV0218A65556

Product of China
Packaged and Quality Assured in the USA

Signature Care 44-655

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-655
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
MINERAL OIL 
POLYETHYLENE GLYCOL, UNSPECIFIED 
PROPYLENE GLYCOL 
SORBITOL 
Product Characteristics
ColorORANGE (clear) Scoreno score
ShapeOVALSize13mm
FlavorImprint Code655
Contains    
Packaging
#Item CodePackage Description
1NDC:21130-655-561 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 - Better Living Brands, LLC (009137209)
Establishment
NameAddressID/FEIOperations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd421293287API MANUFACTURE(21130-655)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(21130-655)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(21130-655)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(21130-655)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(21130-655)

 
Better Living Brands, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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