FDA.reportPublic FDA data

DOCUSATE SODIUM

Manufacturer
Sam's West Inc | Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2024-10-24
Label type
Human OTC Drug Label
Version
4
Source
full-release
Hydrated at
2026-06-01 00:29:10

Label at a glance#

ProductDOCUSATE SODIUM
Active ingredientDOCUSATE SODIUM
Label structure13 sections

Indications and uses

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

Dosage and administration

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 1-3 softgel daily children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor

Storage and handling

each capsule contains: sodium 5 mg Very Low Sodium store at 25°C (77°F); excursions permitted between 15-30ºC (59-86ºF). Keep tightly closed.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each softgel)

Docusate sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

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 stool softener 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 only by mouth. Doses may be taken as a single daily dose or in divided doses.


adults and children 12 years and over
take 1-3 softgel daily
children 2 to under 12 years of age
take 1 softgel daily
children under 2 years
ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each capsule contains: sodium 5 mg Very Low Sodium
  • store at 25°C (77°F); excursions permitted between 15-30ºC (59-86ºF). Keep tightly closed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red No.33, gelatin, glycerin, Neelicert FD&C Red No.40, Neelicert FD&C Yellow No.6, noncrystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, shellac glaze, titanium dioxide.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-855-274-4122 (toll-free)

(Monday - Friday 8:30 AM to 5:00 PM EST)


*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.


DISTRIBUTED BY
SAM'S WEST, INC.
BENTONVILLE, AR 72716

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg (600 Capsules Container Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Colace®
active ingredient*

NDC 68196-995-64


Member's Mark™

Stool
Softener

Docusate sodium 100 mg

Regular Strength

  • Gentle, Dependable
  • Stimulant-free

600 Softgels
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg (600 Capsules Container Label)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg (600 Capsules Container Label)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN4
1115005docusate sodium 100 MG Oral CapsuleSCD4
1115005DOSS Sodium 100 MG Oral CapsuleSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-995-64DOCUSATE SODIUM600 in 1 BOTTLECAPSULE6004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-995DOCUSATE SODIUM CAPSULE [SAM'S WEST INC]4Current NDC, Legacy NDC, 1 package rows20241025_b0e99ebb-41fc-459f-86d2-f0e3527f97b0.zip

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
68196-99568196-995-64

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
D&C RED NO. 339DBA0SBB0LIACT
GELATIN TYPE B BOVINE (160 BLOOM)1T8387508XIACT
GLYCERINPDC6A3C0OXIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
SORBITOL506T60A25RIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SHELLAC46N107B71OIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
DOCUSATE SODIUMDOCUSATE SODIUMSam's West Incb0e99ebb-41fc-459f-86d2-f0e3527f97b02024-10-24WarningsExact identifier
ndc (package): 68196-995-64
ndc (product): 68196-995
ndc11 (package): 68196099564
spl id: 77056696-8140-4c66-a342-49a97fa03507
spl set id: b0e99ebb-41fc-459f-86d2-f0e3527f97b0

Reported adverse events (FAERS/openFDA)#

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