FDA.reportPublic FDA data

DOCUSATE SODIUM, EXTRA STRENGTH

Manufacturer
Advanced Rx LLC
Effective date
2024-09-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:19:40

Label at a glance#

ProductDOCUSATE SODIUM, EXTRA STRENGTH 250 MG
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Indications and uses

for the prevention of dry, hard stools for relief of occasional constipation this product generally produces a bowel movement within 12 to 72 hours

Dosage and administration

adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor children under 12 years of age: ask a doctor

Storage and handling

each softgel contains: sodium 20 mg store at 20°- 25°C (68°- 77°F); excursions permitted between 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH SOFTGEL)

OTC - ACTIVE INGREDIENT SECTION

DOCUSATE SODIUM 250 MG

PURPOSE

OTC - PURPOSE SECTION

Stool softener laxative

USES

INDICATIONS & USAGE SECTION

  • for the prevention of dry, hard stools
  • for relief of occasional constipation
  • this product generally produces a bowel movement within 12 to 72 hours

WARNINGS

WARNINGS SECTION

Do not use if you are presently taking mineral oil, unless directed by a doctor.


Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

  • 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 laxative for more than 1 week

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 (1-800-222-1222) right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
  • children under 12 years of age: ask a doctor

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • each softgel contains: sodium 20 mg
  • store at 20°- 25°C (68°- 77°F); excursions permitted between 15°-30°C (59°-86°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

edible ink, FD&C red #40, FD&C yellow #6, gelatin (bovine), glycerin, polyethylene glycol, purified water, sorbitol special.

QUESTIONS?

OTC - QUESTIONS SECTION

call 1-800-630-8895

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b lbl-PDP_Docusate Sodium_250mg_10001b lbl-PDP_Docusate Sodium_250mg_100

01b lbl-DF_Docusate Sodium_250mg_10001b lbl-DF_Docusate Sodium_250mg_100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245468docusate sodium 250 MG Oral CapsulePSN4
1245468docusate sodium 250 MG Oral CapsuleSCD4
1245468DOSS Sodium 250 MG Oral CapsuleSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80513-100-01DOCUSATE SODIUM, EXTRA STRENGTH250 MG100 in 1 BOTTLECAPSULE, GELATIN COATED1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80513-100DOCUSATE SODIUM, EXTRA STRENGTH 250 MG (DOCUSATE SODIUM) CAPSULE, GELATIN COATED [ADVANCED RX LLC]4Current NDC, Legacy NDC, 1 package rows20240918_e8be12c5-c591-eadd-e053-2a95a90a431b.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
80513-10080513-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C YELLOW NO. 6H77VEI93A8IACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
GELATIN TYPE B BOVINE (160 BLOOM)1T8387508XIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
SORBITOL SOLUTION8KW3E207O2IACT
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
DOCUSATE SODIUM, EXTRA STRENGTH 250 MGDOCUSATE SODIUMAdvanced Rx LLCe8be12c5-c591-eadd-e053-2a95a90a431b2024-09-13WarningsExact identifier
ndc (package): 80513-100-01
ndc (product): 80513-100
ndc11 (package): 80513010001
spl id: 220d2464-6ee6-10d6-e063-6394a90a4f39
spl set id: e8be12c5-c591-eadd-e053-2a95a90a431b

Reported adverse events (FAERS/openFDA)#

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