FDA.reportPublic FDA data

Docusate Sodium

Manufacturer
Reliable-1 Laboratories LLC
Effective date
2022-08-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:50:29

Label at a glance#

ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure11 sections

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each softgel)

Docusate sodium 100 mg

OTC - PURPOSE SECTION

Purpose

Stool softener laxative

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

OTC - STOP USE SECTION

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 stool softner 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.

DOSAGE & ADMINISTRATION SECTION

Directions

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

STORAGE AND HANDLING SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

OTC - QUESTIONS SECTION

Questions or comments? Call 516-341-0666 8:30 am - 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

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

*Reliable-1 Laboratories LLC is not affiliated with the owner of the trademark Colace®

Distributed by: Reliable-1 Laboratories LLC Valley Stream, NY 11580

www.reliable1labs.com

Made in Romania

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69618-044-10

*Compare to the active ingredient in Colace®

Reliable-1™ LABORATORIES

Docusate Sodium 100 mg

STOOL SOFTENER LAXATIVE

1000 SOFTGELS

LabelLabel

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
69618-044-012024-01-30C16284748780-11030e365-676e-111a-e063-dadaa90a10e2Docusate Sodium 100 mg
69618-044-102024-01-30C16284748780-11030e365-676e-111a-e063-dadaa90a10e2Docusate Sodium 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-044-01Docusate Sodium100 in 1 BOTTLE, PLASTICCAPSULE1004
69618-044-10Docusate Sodium1000 in 1 BOTTLE, PLASTICCAPSULE10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-044DOCUSATE SODIUM CAPSULE [RELIABLE-1 LABORATORIES LLC]4Legacy NDC, 2 package rows20220819_597bab7a-3b62-1083-e053-2a91aa0a9d48.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-044-01EA - Each69618-0445b004dec-1b24-4e29-89ef-d73df6f2479412017-12-14
69618-044-10EA - Each69618-044f28ec5a7-79ec-485d-b308-0d36c8d3e13c12017-12-14

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
69618-04469618-044-01, 69618-044-10

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
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
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
e670daa7-a1cb-8ab3-e053-2a95a90aa17d597bab7a-3b62-1083-e053-2a91aa0a9d482022-08-17WarningsExact identifier
spl id: e670daa7-a1cb-8ab3-e053-2a95a90aa17d
spl set id: 597bab7a-3b62-1083-e053-2a91aa0a9d48

Reported adverse events (FAERS/openFDA)#

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