Sennosides, Docusate sodium

Manufacturer
Major Pharmaceuticals
Effective date
2019-10-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:07:04

Label at a glance#

ProductSennosides, Docusate sodium
Active ingredientDOCUSATE SODIUM, SENNOSIDES
Label structure10 sections

Indications and uses

for overnight relief from occasional constipation (irregularity) generally produces bowel movement in 6 to 12 hours

Dosage and administration

take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses. adults and children 12 years and older take 2-4 tablets daily children 6 to under 12 years of age take 1-2 tablets daily children 2 to under 6 years of age take up to 1 tablet daily children under 2 ask a doctor

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

OTC - PURPOSE SECTION

Purposes

Stool softener

Stimulant laxative

Uses 

INDICATIONS & USAGE SECTION

  • for overnight relief from occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

  • laxative products for longer than 1 week unless directed by a doctor 
  • if you are now taking mineral oil, unless directed 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 a period of 2 weeks

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 may indicate a serious condition.

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 may indicate a serious condition.

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.

OVERDOSAGE SECTION

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, preferably in the evening, or in divided doses.

adults and children 12 years and older

take 2-4 tablets daily

children 6 to under 12 years of age

take 1-2 tablets daily

children 2 to under 6 years of age

take up to 1 tablet daily

children under 2

ask a doctor

Other information

OTHER SAFETY INFORMATION

  • each tablet contains: calcium 11 mg
  • each tablet contains: sodium 4 mg
  • store at 25°C (77°F); excursions permitted between 15º-30ºC (59º-86ºF)

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide and triacetin.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1 (800) 616-2471

SPL UNCLASSIFIED SECTION

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

Distributed by: MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152 USA

†This product is not manufactured or distributed by Purdue Products L.P., distributor of Colace®2-IN-1.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR ®

NDC 0904-6723-60

A Stimulant Laxative & Stool Softener For Use in the Management of Temporary Constipation

DOK TM PLUS

(Docusate Sodium 50 mg and Sennosides 8.6 mg)

Compare to the active ingredients in COLACE®2-IN-1†

100 Tablets

3052C-100ct-major label3052C-100ct-major label

3052C-major label3052C-major label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6723-60EA - Each0904-67230035e38d-0716-4abc-aec8-ade3292a1b8812019-03-12
0904-6723-61EA - Each0904-672327f2a165-f87b-4e9c-8ce2-ce3cbaa592c612019-02-13

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-67230904-6723-60, 0904-6723-61

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

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
9521cd07-89a7-6a22-e053-2a95a90a3da178ffc08c-7d24-7b27-e053-2a91aa0a50292019-10-17WarningsExact identifier
spl id: 9521cd07-89a7-6a22-e053-2a95a90a3da1
spl set id: 78ffc08c-7d24-7b27-e053-2a91aa0a5029

Reported adverse events (FAERS/openFDA)#

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