FDA.reportPublic FDA data

Stool Softener

Manufacturer
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Effective date
2024-03-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:10:09

Label at a glance#

ProductStool Softener Extra Strength
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Indications and uses

for relief of occasional constipation this product generally produces a bowel movement within 12 to 72 hours

Dosage and administration

adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor children under 12 years of age: ask a doctor

Storage and handling

each softgel contains : sodium 15 mg store at 20º-25ºC (68º-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 250 mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Uses

INDICATIONS & USAGE SECTION

  • for relief of occasional constipation
  • this product generally produces a bowel movement within 12 to 72 hours

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you are presently taking mineral oil, unless directed 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
  • children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each softgel contains: sodium 15 mg
  • store at 20º-25ºC (68º-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-287-1915

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extra Strength

Stool Softener

Docusate Sodium, 250 mg

Stool Softener Laxative

  • Stimulant free
  • Relief of occasional constipation

SOFTGELS

Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716

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

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EQUATE Extra Strength Stool Softener Laxative
EQUATE Extra Strength Stool Softener Laxative

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245468docusate sodium 250 MG Oral CapsulePSN4
1245468docusate sodium 250 MG Oral CapsuleSCD4
1245468DOSS Sodium 250 MG Oral CapsuleSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-378-14Stool SoftenerExtra Strength140 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-378STOOL SOFTENER EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]4Legacy NDC, 1 package rows20240322_6cc9e30c-dd32-42b2-890c-a8e026ed0cca.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-378-14EA - Each49035-378e18b81d9-9463-4baf-8d7b-3fc90857326e12024-09-09

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-37849035-378-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
MANNITOL3OWL53L36AIACT
SORBITAN6O92ICV9RUIACT

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
e782612b-29fa-4e8d-861c-4fe3008da55d6cc9e30c-dd32-42b2-890c-a8e026ed0cca2024-03-20WarningsExact identifier
spl id: e782612b-29fa-4e8d-861c-4fe3008da55d
spl set id: 6cc9e30c-dd32-42b2-890c-a8e026ed0cca

Reported adverse events (FAERS/openFDA)#

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