FDA.reportPublic FDA data

Docusate Sodium

Manufacturer
Reliable 1 Laboratories LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Effective date
2019-11-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:01:40

Label at a glance#

ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure19 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 divided 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

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 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 bowel movement after use of a laxative. These could be sings of a serious condition.
  • you need to use a stool softener 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.

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

  • each softgel contains: sodium 5 mg
  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special and white edible ink

Questions or comments ?

OTC - QUESTIONS SECTION

Call 516-341-066 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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by: Reliable-1 Laboratories LLC Valley Stream, NY 11580 www.reliable1labs.com

PRINCIPLINE DISPLAY PANEL - Bottle Label 100ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69618-043-01

Docusate Sodium 100 mg 100 SOFTGELS

STOOL SOFTENER LAXATIVE

Bottle Label 100ct frontBottle Label 100ct front

Bottle Label 100ct backBottle Label 100ct back

PRINCIPLINE DISPLAY PANEL - Bottle Label 1000ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69618-043-10

Docusate Sodium 100 mg 1000 SOFTGELS

STOOL SOFTENER LAXATIVE

Bottle Label 1000ctBottle Label 1000ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN3
1115005docusate sodium 100 MG Oral CapsuleSCD3
1115005DOSS Sodium 100 MG Oral CapsuleSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69618-043-012025-01-30C16284748780-12cef2736-7cba-d83d-e063-dadaa90ab31fDocusate Sodium 100 mg
69618-043-102025-01-30C16284748780-12cef2736-7cba-d83d-e063-dadaa90ab31fDocusate Sodium 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-043-01Docusate Sodium100 in 1 BOTTLE, PLASTICCAPSULE1003
69618-043-10Docusate Sodium1000 in 1 BOTTLE, PLASTICCAPSULE10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-043DOCUSATE SODIUM CAPSULE [RELIABLE 1 LABORATORIES LLC]3Legacy NDC, 2 package rows20191126_383ce892-de63-62e8-e054-00144ff88e88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-043-01EA - Each69618-0432e6984cc-9cb0-4f21-97c2-1fd1a76b902e12017-03-06
69618-043-10EA - Each69618-043f63a7d85-fd11-4e32-a4b7-685f87a24a5b12017-03-06

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69618-04369618-043-01, 69618-043-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
D&C RED NO. 339DBA0SBB0LIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB
FD&C YELLOW NO. 6H77VEI93A8IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
3b94cfb2-6dd2-4b3c-9047-e2a97e458efb383ce892-de63-62e8-e054-00144ff88e882019-11-25WarningsExact identifier
spl id: 3b94cfb2-6dd2-4b3c-9047-e2a97e458efb
spl set id: 383ce892-de63-62e8-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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