FDA.reportPublic FDA data

DOCUSATE SODIUM

Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:43:06

Label at a glance#

ProductDOCUSATE SODIUM
Active ingredientDOCUSATE SODIUM
Label structure14 sections

Indications and uses

for temporary relief of occasional constipation and irregularity this product generally produces a bowel movement within 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 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses Children 2 to under 12 years of age 1 softgel daily. Children under 2 years of age Ask a doctor

Storage and handling

Store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) Keep tightly closed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg 

Purpose

OTC - PURPOSE SECTION

Stool Softner

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • stomach pain, nausea or vomittiong
  • a sudden change in bowel habits that lasts more than 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 laxative for more than 1 week.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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

1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses

Children 2 to under 12 years of age

1 softgel daily.

Children under 2 years of age

Ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • Store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • Keep tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Red#40, FD&C Yellow#6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cabinet:
Stool Softener
Docusate Sodium 100mg

75 Softgels

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN7
1115005docusate sodium 100 MG Oral CapsuleSCD7
1115005DOSS Sodium 100 MG Oral CapsuleSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68210-4104-02026-01-29C16284748780-149896155-c496-586f-e063-e6dba90add90Docusate Sodium 100mg
68210-4104-12026-01-29C16284748780-149896155-c496-586f-e063-e6dba90add90Docusate Sodium 100mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4104-0DOCUSATE SODIUM100 in 1 BOTTLECAPSULE, LIQUID FILLED1007
68210-4104-1DOCUSATE SODIUM75 in 1 PACKAGECAPSULE, LIQUID FILLED757

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4104DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]7Legacy NDC, 2 package rows20241215_31e711c1-24a0-4b57-9f03-3fc22c6bcba0.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68210-410468210-4104-1, 68210-4104-0

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
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB

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
292d7a26-c25e-72df-e063-6394a90a519831e711c1-24a0-4b57-9f03-3fc22c6bcba02024-12-13WarningsExact identifier
spl id: 292d7a26-c25e-72df-e063-6394a90a5198
spl set id: 31e711c1-24a0-4b57-9f03-3fc22c6bcba0

Reported adverse events (FAERS/openFDA)#

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