FDA.reportPublic FDA data

Stool Softener Docusate Sodium

Manufacturer
Magno-Humphries, Inc.
Effective date
2023-10-27
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:58:14

Label at a glance#

ProductStool Softener Docusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure11 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces a bowel movement in 12-72 hours

Dosage and administration

Take only by mouth. This dose may be taken as a single daily dose or in divided doses. ​take 1-3 softgels daily or as directed by a doctor ​adults and children over 12 years of age: ​ take 1 softgel daily or as directed by a doctor ​children 2 to under 12 years of age: ​ask a doctor ​children under 2 years of age:

Label contents#

Full prescribing information#

MHL NDC 54257-902-06

SPL UNCLASSIFIED SECTION

Stool Softener Docusate Sodium 100mg Compare to the active ingredient in Colace *


®

Effective, Gentle Stimulant Free For Comfortable Relief


1000 SOFTGELS

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 12-72 hours

Warnings

WARNINGS SECTION

​Do not use

​Ask a doctor before use if you have

​Stop use and ask a doctor if

​ask a health professional before use. ​If pregnant or breast-feeding,

​

  • if you are presently taking mineral oil, unless told by a doctor
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel movements that continues over a period of 2 weeks
  • you have rectal bleeding or you 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 for mroe than 1 week.

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 ( ​) right away. ​1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take only by mouth. This dose may be taken as a single daily dose or in divided doses.
  • ​take 1-3 softgels daily or as directed by a doctor ​adults and children over 12 years of age:
  • ​ take 1 softgel daily or as directed by a doctor ​children 2 to under 12 years of age:
  • ​ask a doctor ​children under 2 years of age:

Other information

SPL UNCLASSIFIED SECTION

  • ​sodium 7mg ​each softgel contains:
  • store between 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 400, purified water, sorbitol.

Questions?

OTC - QUESTIONS SECTION

call toll-free ​1-800-935-6737

*This product is not manufactured or distributed by the owner of the registered trademark Colace®. Distributed by: Magno-Humphries, Inc. OR 97223 U.S.A. ​Visit our website: www.magno-humphries.com

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by the owner of the registered trademark Colace®.

Distributed by: , OR 97223 U.S.A.



Magno-Humphries, Inc. ​Visit our website: www.magno-humphries.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Drug FactsDrug Facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN5
1115005docusate sodium 100 MG Oral CapsuleSCD5
1115005DOSS Sodium 100 MG Oral CapsuleSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54257-902-062023-10-29C16284748780-1ba0f9c33-2cdc-a910-e053-dadaa90a0b85Stool Softener Docusate Sodium
54257-902-062021-01-29C16284748780-1ba0f9c33-2cdc-a910-e053-dadaa90a0b85Stool Softener Docusate Sodium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54257-902-06Stool Softener Docusate Sodium1000 in 1 BOTTLECAPSULE, GELATIN COATED10005

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.]5Current NDC, Legacy NDC, 1 package rows20231030_a0e6ab9b-fd31-45fd-93d5-b51d705c180a.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 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54257-90254257-902-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
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 (package): 54257-902-06
ndc (product): 54257-902
ndc11 (package): 54257090206
spl id: 08bf67ab-e837-2223-e063-6294a90a0878
spl set id: a0e6ab9b-fd31-45fd-93d5-b51d705c180a
Stool Softener Docusate SodiumDOCUSATE SODIUMMagno-Humphries, Inc.9d22d642-8aed-d17e-e053-2995a90ae1822023-10-27WarningsExact identifier
ndc (product): 54257-902

Reported adverse events (FAERS/openFDA)#

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