FDA.reportPublic FDA data

DOK Plus Tablets

Manufacturer
Major Pharmaceuticals
Effective date
2019-08-27
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-02 00:14:06

Label at a glance#

ProductSenna/Docusate Sodium
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

OTC - PURPOSE SECTION

Purpose
Stool Softener
Stimulant Laxative

INDICATIONS & USAGE SECTION

Uses relieves occasional constipation (irregularity). This product generally produces a bowel movement in 6 to 12 hours.

WARNINGS SECTION

Warnings

Ask a doctor before use if you have

  • Stomach pain
  • Nausea
  • Vomiting
  • A sudden change in bowel habits that lasts over a period of 2 weeks.

DO NOT USE

Laxative products for longer than 1 week unless directed by a doctor

If you are presently taking mineral oil, unless directed by a doctor

Ask Doctor/Pharmacist

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are presently taking mineral oil.

DOSAGE & ADMINISTRATION SECTION

Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided dose.

Age

Dosage

Adults and children

12 years of age and older

Take 2-4 tablets daily

Children 6 to under 12 years

Take 1-2 tablets daily

Children 2 to 6 years

Take up to 1 tablet daily

Children under 2 years

Do not use

Generic Section

SPL UNCLASSIFIED SECTION

Other information

  • Each tablet contains: sodium 6 mg/tablet VERY LOW SODIUM
  • Each tablet contains: calcium 20 mg/tablet.
  • Store at 20° - 25°C (68° -77°F); excursions permitted to 15°-30° (59°-86°F). [See USP Controlled Room Temperature]

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Carnauba Wax, Colloidal Silicon Dioxide, Croscarmellose Sodium, Dibasic Calcium Phosphate Dihydrate, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, tapioca starch*, tartaric acie*, and titanium dioxide. *may contain these ingredients.

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.

Questions

OTC - QUESTIONS SECTION

Questions? To Report Serious Adverse Effects Call: (800)616-2471

Distributed By:

Major® Pharmaceuticals

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152 USA

LHC51790417

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DOK Plus Tablets

(Docusate Sodium & Sennosides)

50/8.6 mg

100 Tablets

carton label
carton label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5643-60EA - Each0904-5643672627f1-a8ac-46c7-b78a-454c6773bfdf12013-02-11
0904-5643-61EA - Each0904-56434c34882b-7edf-4eca-adef-036c1f6224c312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA05
SENNOSIDESACTIVE INGREDIENT3FYP5M0IJX5
DOCUSATEACTIVE MOIETYM7P27195AG5
SENNOSIDESACTIVE MOIETY3FYP5M0IJX5
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEP5
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH485
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I305
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU45
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU5
STARCH, TAPIOCAINACTIVE INGREDIENT24SC3U704I5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP5
TARTARIC ACIDINACTIVE INGREDIENTW4888I119H5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP5

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-56430904-5643-61, 0904-5643-60
49483-097

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SENNOSIDES3FYP5M0IJXACTIB
DOCUSATE SODIUMF05Q2T2JA0ACTIB
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C RED NO. 40WZB9127XOAIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SODIUM BENZOATEOJ245FE5EUIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, FILM COATED / ORAL953 mgExact identifier — unii+route+dosage form
STARCH, TAPIOCASTARCH, TAPIOCA24SC3U704ICAPSULE / ORAL100 mgExact identifier — unii+route
2 equally ranked IID candidates
STARCH, TAPIOCASTARCH, TAPIOCA24SC3U704ITABLET / ORAL5 mgExact identifier — unii+route
2 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
TARTARIC ACIDTARTARIC ACIDW4888I119HTABLET, FILM COATED / ORAL30 mgExact identifier — unii+route+dosage form
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii+route+dosage form

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENNOSIDES AND DOCUSATE SODIUMSENNOSIDES AND DOCUSATE SODIUMTIME CAP LABORATORIES, INC0ad617e0-10a6-44fa-be62-4f3cc725fb012025-02-08WarningsExact identifier
ndc (product): 49483-097
0c93d8c4-100c-4868-95c1-a889f58c04ae3432270b-469e-48d2-850f-0177365775fa2019-08-27WarningsExact identifier
spl id: 0c93d8c4-100c-4868-95c1-a889f58c04ae
spl set id: 3432270b-469e-48d2-850f-0177365775fa

Reported adverse events (FAERS/openFDA)#

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