FDA.reportPublic FDA data

DOCUSATE SODIUM

Manufacturer
WALGREEN COMPANY
Effective date
2026-01-19
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:33:47

Label at a glance#

ProductDOCUSATE SODIUM
Active ingredientDOCUSATE SODIUM
Label structure15 sections

Indications and uses

relieves of occasional constipation (irregularity) this product generally produces a bowel movement within 12 to 72 hours

Dosage and administration

take with a glass of water take 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 of age 1 capsule daily. Children under 2 years of age Ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each liquid-filled capsule)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg 

Purpose

OTC - PURPOSE SECTION

Stool Softner laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves of occasional constipation (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

OTC - DO NOT USE SECTION

Do not use if you are presently taking mineral oil, unless told to do so by a doctor

Stop use and ask a doctor if you

OTC - STOP USE SECTION

  • you have rectal bleeding ot no bowel movement after using this product. These could be signs of a serious condition.
  • yo 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 with a glass of water

take 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 of age

1 capsule daily.

Children under 2 years of age

Ask a doctor

Other information

OTHER SAFETY INFORMATION

  • Store at room temperature 20-25°C  (68-77°F) 
  • protect from excessive humidity
  • do not use this product of the safety seal under the cap is torn or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Dulcolax ® Stool Softener active ingredient *

GENTLE STOOL SOFTENER

DOCUSATE SODIUM 100 mg / STOOL SOFTENER LAXATIVE

25 LIQUID GELS

GSSGSS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN8
1115005docusate sodium 100 MG Oral CapsuleSCD8
1115005DOSS Sodium 100 MG Oral CapsuleSY8

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-8991-25DOCUSATE SODIUM1 in 1 PACKAGECAPSULE, LIQUID FILLED18
0363-8991-25DOCUSATE SODIUM25 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED258

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
0363-89910363-8991-25

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
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB
POVIDONE K30U725QWY32XIACT

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 SODIUMWALGREEN COMPANY21fbddce-d3e7-4090-9e69-f4e07fa97ba22026-01-19WarningsExact identifier
ndc (package): 0363-8991-25
ndc (product): 0363-8991
ndc11 (package): 00363899125
spl id: 48c1e58f-8191-0362-e063-6394a90a7d8b
spl set id: 21fbddce-d3e7-4090-9e69-f4e07fa97ba2

Reported adverse events (FAERS/openFDA)#

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