FDA.reportPublic FDA data

Stool Softener

Manufacturer
Discount Drug Mart | LNK International, Inc.
Effective date
2021-10-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:34:13

Label at a glance#

ProductStool Softener
Active ingredientDOCUSATE SODIUM
Label structure9 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient (in each liquid-filled capsule)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you are presently taking mineral oil, unless told to do so by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53943-655-12

May Contain Anti Theft Device

DISCOUNT
drug
mart
FOOD FAIR

STOOL
SOFTENER

Docusate Sodium 100 mg
Stool Softener Laxative

Gentle & dependable

Stimulant-free for
comfortable relief

100 Liquid Capsules

Actual Size

*Compare to the active ingredient in Dulcolax®

*This product is not manufactured or distributed
by Sanofi-Aventis Deutschland GMBH, owner of
the registered trademark Dulcolax®.

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

50844     ORG021865512

Product of China                    
Packaged and Quality Assured in the USA

DISTRIBUTED BY: DRUG MART - FOOD FAIR
211 COMMERCE DRIVE, MEDINA, OH 44256
www.discount-drugmart.com

SATISFACTION GUARANTEED
IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE
TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO
STORE, SEND REASON FOR DISSATISFACTION, NAME,
ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART
211 COMMERCE DRIVE, MEDINA, OHIO 44256

Drug Mart 44-655
Drug Mart 44-655

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53943-65553943-655-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
90aafded-e431-4ffd-99fb-431254b8c738f0f4fda7-78af-49f5-bb93-2ab172edc0c72021-10-04WarningsExact identifier
spl id: 90aafded-e431-4ffd-99fb-431254b8c738
spl set id: f0f4fda7-78af-49f5-bb93-2ab172edc0c7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.