OTC Medication Information: Stool Softener

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.

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 over take 1 to 3 capsules daily
children 2 to under 12 years take 1 capsule daily
children under 2 years 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

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 ChinaPackaged and Quality Assured in the USA

Signature Care 44-655
(click image for full-size original)

Signature Care 44-655

STOOL SOFTENER docusate sodium capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-655
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 100 mg
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN, UNSPECIFIED
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
SORBITOL
ANHYDROUS CITRIC ACID
WATER
Product Characteristics
Color orange (clear) Score no score
Shape OVAL Size 13mm
Flavor Imprint Code 655
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21130-655-56 1 BOTTLE in 1 CARTON contains a BOTTLE
1 25 CAPSULE, LIQUID FILLED in 1 BOTTLE This package is contained within the CARTON (21130-655-56)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 03/01/2015
Labeler — Better Living Brands, LLC (009137209)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (21130-655)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 pack (21130-655)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 pack (21130-655)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (21130-655)

Revised: 06/2022 Better Living Brands, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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