FDA.reportPublic FDA data

STOOL SOFTENER

Manufacturer
Walgreen Co. | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Effective date
2024-11-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:38:47

Label at a glance#

ProductSTOOL SOFTENER
Active ingredientDOCUSATE SODIUM
Label structure11 sections

Indications and uses

for relief of occasional constipation (irregularity) this product generally produces a bowel movement in 12 to 72 hours

Dosage and administration

take softgels with a full glass (8oz) of water adults and children 12 years and older      take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in             divided doses. children 6 to under 12 years       take 1 softgel daily or as directed by a doctor children under 6 years       ask a doctor

Storage and handling

each softgel contains: sodium 5 mg store at room temperature 15°-30°C (59°-86°F)  protect from excessive humidity

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 softener laxative

Uses

INDICATIONS & USAGE SECTION

  • for relief of occasional constipation (irregularity)
  • this product generally produces a bowel movement in 12 to 72 hours

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • stomach pain, nausea, or vomiting
  • a sudden change in bowel habits that lasts over 14 days

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
  • you need to use a 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.

Directions

DOSAGE & ADMINISTRATION SECTION

take softgels with a full glass (8oz) of water

adults and children 12 years and older

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

children 6 to under 12 years 

     take 1 softgel daily or as directed by a doctor

children under 6 years 

     ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each softgel contains: sodium 5 mg
  • store at room temperature 15°-30°C (59°-86°F) 
  • protect from excessive humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stool Softener

DOCUSATE SODIUM 100 mg 30 SOFTGELS

Compare to Phillips' Stool Softener Liquid Gels active ingredient

NDC 0363-9944-20

Carton label frontCarton label front

Carton label backCarton label back

PRINCIPAL DISPLAY PANEL - Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stool Softener

DOCUSATE SODIUM 100 mg 30 SOFTGELS

Compare to Phillips' Stool Softener Liquid Gels active ingredient

NDC 0363-9944-20

Bottle label frontBottle label front

Bottle label backBottle label back

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
0363-9944-20STOOL SOFTENER30 in 1 BOTTLECAPSULE, LIQUID FILLED304
0363-9944-20STOOL SOFTENER1 in 1 CARTONCAPSULE, LIQUID FILLED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9944STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [WALGREEN CO.]4Current NDC, Legacy NDC, 2 package rows20241123_d8d97ca5-5131-4620-8ce9-bc3f9d5c0ab5.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
0363-99440363-9944-20

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SORBITAN6O92ICV9RUIACT
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
STOOL SOFTENERDOCUSATE SODIUMWalgreen Co.d8d97ca5-5131-4620-8ce9-bc3f9d5c0ab52024-11-21WarningsExact identifier
ndc (package): 0363-9944-20
ndc (product): 0363-9944
ndc11 (package): 00363994420
spl id: 27784b77-2a11-92bf-e063-6394a90a4617
spl set id: d8d97ca5-5131-4620-8ce9-bc3f9d5c0ab5

Reported adverse events (FAERS/openFDA)#

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