FDA.reportPublic FDA data

Stool Softener Docusate Sodium

Manufacturer
Magno-Humphries, Inc.
Effective date
2023-10-27
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:58:14

Label at a glance#

ProductStool Softener Docusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure8 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, preferably in the evening, or in divided doses.  adults and children 12 years of age and older  take 1 to 3  softgels daily  children 2 to under 12 years of age  take 1 softgel daily  children under 2 years  ask a doctor

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 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

OTC - DO NOT USE SECTION

  • 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 lasts 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.
 adults and children 12 years of age and older take 1 to 3  softgels daily
 children 2 to under 12 years of age take 1 softgel daily
 children under 2 years ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • ach softgel contains: sodium 7mg 
  • store at 15° to 30°C (59° to 86°F)
  • protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-800-935-6737

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label13Label13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN6
1115005docusate sodium 100 MG Oral CapsuleSCD6
1115005DOSS Sodium 100 MG Oral CapsuleSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54257-902-02Stool Softener Docusate Sodium100 in 1 BOTTLECAPSULE, GELATIN COATED1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54257-902STOOL SOFTENER DOCUSATE SODIUM (DOCUSATE SODIUM) CAPSULE, GELATIN COATED [MAGNO-HUMPHRIES, INC.]6Current NDC, Legacy NDC, 1 package rows20231030_9d22d642-8aed-d17e-e053-2995a90ae182.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54257-902-06EA - Each54257-9021b79f6cd-2f3a-4d3f-bbd4-66d8f726563212018-05-09

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54257-90254257-902-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C YELLOW NO. 6H77VEI93A8IACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
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
Stool Softener Docusate SodiumDOCUSATE SODIUMMagno-Humphries, Inc.a0e6ab9b-fd31-45fd-93d5-b51d705c180a2023-10-27WarningsExact identifier
ndc (product): 54257-902
Stool Softener Docusate SodiumDOCUSATE SODIUMMagno-Humphries, Inc.9d22d642-8aed-d17e-e053-2995a90ae1822023-10-27WarningsExact identifier
ndc (package): 54257-902-02
ndc (product): 54257-902
ndc11 (package): 54257090202
spl id: 08bf70ec-89c9-36e5-e063-6294a90a6772
spl set id: 9d22d642-8aed-d17e-e053-2995a90ae182

Reported adverse events (FAERS/openFDA)#

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