SENNA WITH DOCUSATE SODIUM

Manufacturer
HHH Pharmaceuticals | Elysium Pharmaceuticals Ltd
Effective date
2025-10-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:38:28

Label at a glance#

ProductSENNA WITH DOCUSATE SODIUM
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure9 sections

Indications and uses

relieves occasional constipation (irregularity) generally causes bowel movement in 6-12 hours

Dosage and administration

take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage adults and children 12 years of age and over 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years ½ tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor

Storage and handling

each tablet contains: calcium 21 mg, sodium 3 mg. VERY LOW SODIUM store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each tablet)                    Purpose

Docusate sodium 50 mg.......................................Stool softner

Sennosides 8.6 mg................................................Laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally causes bowel movement in 6-12 hours

Warnings

WARNINGS SECTION

Do not use

SPL UNCLASSIFIED SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that continues over a period of 2 weeks.

Stop use and ask a doctor if

OTC - STOP USE SECTION

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

take preferably at bedtime or as directed by a doctor

age

starting dosage

maximum dosage

adults and children 12 years of age and over

2 tablets once a day

4 tablets twice a day

children 6 to under 12 years

1 tablet once a day

2 tablets twice a day

children 2 to under 6 years

½ tablet once a day

1 tablet twice a day

children under 2 years

ask a doctor

ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 21 mg, sodium 3 mg. VERY LOW SODIUM
  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, colloidal silicon dioxide, dicalcium phosphate, polyethylene glycol, FD&C red 40 lake, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid powder, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-302-380-3408

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN1
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD1
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83586-001-00SENNA WITH DOCUSATE SODIUM50000 in 1 DRUMTABLET500001

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83586-00183586-001-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
SENNA WITH DOCUSATE SODIUMDOCUSATE SODIUM AND SENNOSIDESHHH Pharmaceuticals2bbb1b99-d43c-40a3-bc53-e18e8394c3182025-10-08WarningsExact identifier
ndc (package): 83586-001-00
ndc (product): 83586-001
ndc11 (package): 83586000100
spl id: 40a17a93-869f-c593-e063-6394a90ad242
spl set id: 2bbb1b99-d43c-40a3-bc53-e18e8394c318

Reported adverse events (FAERS/openFDA)#

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