FDA.reportPublic FDA data

Docusate Sodium

Manufacturer
Marlex Pharmaceuticals Inc
Effective date
2021-10-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:44:27

Label at a glance#

ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure9 sections

Indications and uses

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

Dosage and administration

adults and children 12 years and over take 1 - 3 softgels once daily or in divded doses children 2 to under 12 years of age 1 softgel once daily children under 2 years ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DOCUSATE SODIUM- docusate sodium capsule Marlex Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Docusate Sodium 100 mg

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

  • 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 directed 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

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.
  • you need to use stool softner laxative for more than 1 week

These could be sings of a serious condition.

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 overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and overtake 1 - 3 softgels once daily or in divded doses
children 2 to under 12 years of age1 softgel once daily
children under 2 yearsask a doctor

Other informaiton

SPL UNCLASSIFIED SECTION

  • each softgel contains: s odium 7 mg
  • store at room temperature 15º-25ºC (59º-77ºF) and avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400 NF, purified water, sorbitol

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

*Marlex Pharmaceuticals, Inc., is not affiliated with the owner of the trademark Colace®

Distributed by:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720

Made in Romania

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10135-0111-01
Docusate Sodium
100 mg
100 Softgels

PRINCIPAL DISPLAY PANEL NDC 10135-0111-01 Docusate Sodium 100 mg 100 SoftgelsPRINCIPAL DISPLAY PANEL NDC 10135-0111-01 Docusate Sodium 100 mg 100 Softgels

PRINCIPAL DISPLAY PANEL NDC 10135-0111-01 Docusate Sodium 100 mg 100 SoftgelsPRINCIPAL DISPLAY PANEL NDC 10135-0111-01 Docusate Sodium 100 mg 100 Softgels

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-111-012023-01-30C16284748780-1f386c649-c3f0-0266-e053-dadaa90a7c1aDocusate Sodium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-111-01Docusate Sodium100 in 1 BOTTLECAPSULE, LIQUID FILLED1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-111DOCUSATE SODIUM CAPSULE, LIQUID FILLED [MARLEX PHARMACEUTICALS INC]4Legacy NDC, 1 package rows20211026_c34e6f3d-9a11-4164-a26c-1ef62513c184.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-111-01EA - Each10135-111197e95ae-76a4-4efb-85e6-0a6a89f8d32f12018-11-06

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
10135-11110135-111-01

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 RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cf1c9490-28f8-67f3-e053-2a95a90a7524c34e6f3d-9a11-4164-a26c-1ef62513c1842021-10-24WarningsExact identifier
spl id: cf1c9490-28f8-67f3-e053-2a95a90a7524
spl set id: c34e6f3d-9a11-4164-a26c-1ef62513c184

Reported adverse events (FAERS/openFDA)#

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