DOK

Manufacturer
RedPharm Drug, Inc.
Effective date
2018-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:54:59

Label at a glance#

ProductDOK
Active ingredientDOCUSATE SODIUM
Label structure10 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 or in divided doses. adults and children 12 years and over 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 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 told to do so by a doctor.

Ask a doctor before use if you have

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

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 a signs of a serious condition.
you need to use a laxative for more than 1 week

If pregnant or breast-feeding,

ask a health professional before use.

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

take only by mouth. Doses may be taken as a single daily dose or in divided doses.

adults and children 12 years and over 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

each softgel contains: sodium 6 mg
store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water sorbitan, sorbitol

*contains one or more of these ingredients

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

docusatedocusate

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN2
1115005docusate sodium 100 MG Oral CapsuleSCD2
1115005DOSS Sodium 100 MG Oral CapsuleSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1556-22020-01-31C16284748780-19d75b9d0-6925-f424-e053-dadaa90a57cedocusate
67296-1556-62020-01-31C16284748780-19d75b9d0-6925-f424-e053-dadaa90a57cedocusate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1556-2DOK20 in 1 BOTTLECAPSULE202
67296-1556-6DOK60 in 1 BOTTLECAPSULE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1556DOK CAPSULE [REDPHARM DRUG, INC.]2Legacy NDC, 2 package rows20180323_68165491-0e0c-52d9-e053-2a91aa0ae5f1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6457-60EA - Each0904-6457f74e1376-7353-4058-ae1c-b0189c2e036012015-06-09
0904-6457-80EA - Each0904-6457e11f74e7-d452-4fdd-8512-5c99127d2d2912015-06-09

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67296-155667296-1556-2, 67296-1556-6
0904-6457

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
68165491-0e0d-52d9-e053-2a91aa0ae5f168165491-0e0c-52d9-e053-2a91aa0ae5f12018-01-01WarningsExact identifier
spl id: 68165491-0e0d-52d9-e053-2a91aa0ae5f1
spl set id: 68165491-0e0c-52d9-e053-2a91aa0ae5f1

Reported adverse events (FAERS/openFDA)#

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