STOOL SOFTENER- docusate sodium capsule, liquid filled 
Better Living Brands, 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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Signature Care 44-655-Delisted

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 yearstake 1 capsule daily
children under 2 yearsask 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
Dulcolax® 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
Sanofi-Aventis Deutschland GMBH, distributors of
Dulcolax® Stool Softener.
50844     REV0218B65556           Product of China
Packaged and Quality Assured in the USA

Signature Care 44-655

Signature Care 44-655

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-655
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, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colororange (clear) Scoreno score
ShapeOVALSize13mm
FlavorImprint Code 655
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-655-561 in 1 CARTON03/01/201510/31/2022
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 finalpart33403/01/201510/31/2022
Labeler - Better Living Brands, LLC (009137209)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(21130-655)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837pack(21130-655)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088pack(21130-655)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(21130-655)

Revised: 8/2023
Document Id: f49c4f3c-3f49-45a9-96fa-884aa68261b0
Set id: 56371d3e-d8da-4065-b2c4-79914a02d13b
Version: 10
Effective Time: 20230814
 
Better Living Brands, LLC