FDA.reportPublic FDA data

DOK

Manufacturer
MAJOR PHARMACEUTICALS | Geri-Care Pharmaceuticals, Corp | GCP Laboratories
Effective date
2023-10-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:57:26

Label at a glance#

ProductDOK
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

do not exceed recommended dose adults and children 12 years and older: take 1-3 tablets daily, or as directed by a doctor. May be taken as a single daily dose or in divided doses. children under 12: consult a doctor

Storage and handling

each tablet contains: calcium 50 mg, sodium 10 mg store at room temperature 15°C-30°C (59°F-86°F) Tamper Evident: Do not use if imprinted seal under cap is missing or broken

Label contents#

Full prescribing information#

Active ingredient

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

Ask a doctor before use if you

  • have stomach pain, nausea or vomiting
  • have a sudden change in bowel habits that persists over a period of 2 weeks
  • are presently taking mineral oil

Stop use and ask a doctor if

  • you need to use a laxative longer than 1 week
  • you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition.

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not exceed recommended dose
  • adults and children 12 years and older: take 1-3 tablets daily, or as directed by a doctor. May be taken as a single daily dose or in divided doses.
  • children under 12: consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 50 mg, sodium 10 mg
  • store at room temperature 15°C-30°C (59°F-86°F)
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose, croscarmellose sodium, dicalcium phosphate, magnesium stearate, silica, sodium benzoate, stearic acid, talc

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1099279docusate sodium 100 MG Oral TabletPSN3
1483574DOK 100 MG Oral TabletPSN3
1483574docusate sodium 100 MG Oral Tablet [DOK]SBD3
1099279docusate sodium 100 MG Oral TabletSCD3
1483574DOK 100 MG Oral TabletSY3
1099279DOSS Sodium 100 MG Oral TabletSY3
1483574DOSS Sodium 100 MG Oral Tablet [DOK]SY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6750-60DOK100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6750DOK (DOCUSATE SODIUM) TABLET [MAJOR PHARMACEUTICALS]3Current NDC, Legacy NDC, 1 package rows20231024_7a92070d-98cc-662f-e053-2991aa0aa1b2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6750-60EA - Each0904-67504d763874-e73b-4fa0-96bd-b8786e18ee9912018-12-13

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-67500904-6750-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARIC ACID4ELV7Z65APIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TALC7SEV7J4R1UIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB
SODIUM BENZOATEOJ245FE5EUIACT

Source Document#

Source XML · Source PDF

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
DOKDOCUSATE SODIUMMAJOR PHARMACEUTICALS7a92070d-98cc-662f-e053-2991aa0aa1b22023-10-23WarningsExact identifier
ndc (package): 0904-6750-60
ndc (product): 0904-6750
ndc11 (package): 00904675060
spl id: 08649f2e-5f6c-5ba0-e063-6294a90a5fd1
spl set id: 7a92070d-98cc-662f-e053-2991aa0aa1b2

Reported adverse events (FAERS/openFDA)#

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