FDA.reportPublic FDA data

Docusate Sodium Capsules USP 100 mg

Manufacturer
Softgel Healthcare Pvt Ltd
Effective date
2024-08-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:18:22

Label at a glance#

ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure14 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 capsules daily children 2 to under 12 years of age take 1 capsule daily children under 2 years ask a doctor

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium USP 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 last 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 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 overtake 1-3 capsules daily
children 2 to under 12 years of agetake 1 capsule daily
children under 2 yearsask a doctor

Other information

OTHER SAFETY INFORMATION

  • each softgel contains: Sodium 5 mg
  • store at 25°C (77°F); excursion permitted between 15°-30°C (59°-86°F).

Keep tightly closed.

Inactive ingredient

INACTIVE INGREDIENT SECTION

FD&C red no.40, FD&C yellow no.6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, sorbitol sorbitan solution, water.

TAMPER EVIDENT

SPL UNCLASSIFIED SECTION

Do not use if safety seal under cap is broken or missing

Manufactured by

SPL UNCLASSIFIED SECTION

Softgel Healthcare Pvt. Ltd.,

Survey No. 20/1,

Vandalur-Kelambakkam Road,

Pudupakkam Village,

Kancheepuram District,

Tamilnadu - 603 103, India.

Mfg. Lic. No.: XXXXXXXXXXXX

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Docusate Sodium Capsules USP 100mgDocusate Sodium Capsules USP 100mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN1
1115005docusate sodium 100 MG Oral CapsuleSCD1
1115005DOSS Sodium 100 MG Oral CapsuleSY1

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
35916-0440-12026-01-29C16284748780-149896155-a4ff-586f-e063-e6dba90add90Docusate Sodium Capsules USP 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35916-0440-1Docusate Sodium30 in 1 BOTTLECAPSULE, LIQUID FILLED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35916-0440DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PVT LTD]11 package rows20240901_20b96ed4-bb79-445c-e063-6394a90ae81a.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35916-044035916-0440-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
WATER059QF0KO0RIACT
FD&C RED NO. 40WZB9127XOAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GELATIN2G86QN327LIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB
FD&C YELLOW NO. 6H77VEI93A8IACT
GLYCERINPDC6A3C0OXIACT

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
20b96ed4-bb7a-445c-e063-6394a90ae81a20b96ed4-bb79-445c-e063-6394a90ae81a2024-08-31WarningsExact identifier
spl id: 20b96ed4-bb7a-445c-e063-6394a90ae81a
spl set id: 20b96ed4-bb79-445c-e063-6394a90ae81a

Reported adverse events (FAERS/openFDA)#

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