FDA.reportPublic FDA data

DOCUSATE SODIUM

Manufacturer
A-S Medication Solutions
Effective date
2024-12-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:50:02

Label at a glance#

ProductDOCUSATE SODIUM
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Indications and uses

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

Dosage and administration

take with a glass of water 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

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

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • stomach pain, nausea or vomitting
  • a sudden change in bowel habits that lasts more than 2 weeks

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you arepresently 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 with a glass of water

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

  • 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

FD&C Red # 40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special, citric acid, purified water and white edible ink

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-7479

NDC: 50090-7479-1 100 CAPSULE, LIQUID FILLED in a BOTTLE, PLASTIC

NDC: 50090-7479-4 30 CAPSULE, LIQUID FILLED in a BOTTLE, PLASTIC

DOCUSATE SODIUM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7479-1DOCUSATE SODIUM100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1001
50090-7479-4DOCUSATE SODIUM30 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7479DOCUSATE SODIUM CAPSULE, LIQUID FILLED [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20250101_946abcdb-96bd-43e6-992a-bb97679c00f0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7479-1EA - Each50090-74793630b651-11b0-4f61-a38a-8de7ed18ce3b12025-02-10
50090-7479-4EA - Each50090-7479bb20af48-b142-4ab6-a729-18345c039c0312025-02-10

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
50090-747950090-7479-4, 50090-7479-1
53345-008

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
RED 40WZB9127XOAIACT
KI5H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
AQUA059QF0KO0RIACT
SORBITOL506T60A25RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOCUSATE SODIUMDOCUSATE SODIUMA-S Medication Solutions946abcdb-96bd-43e6-992a-bb97679c00f02024-12-30WarningsExact identifier
ndc (package): 50090-7479-1
ndc (package): 50090-7479-4
ndc (product): 50090-7479
ndc11 (package): 50090747901
ndc11 (package): 50090747904
spl id: ac138ca0-1d8c-4c98-be86-d16fb4d3f2e9
spl set id: 946abcdb-96bd-43e6-992a-bb97679c00f0
DOCUSATE SODIUMDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.b10fdf50-289e-41f3-9b83-a4e4dd892f882024-11-21WarningsExact identifier
ndc (product): 53345-008

Reported adverse events (FAERS/openFDA)#

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