FDA.reportPublic FDA data

Senna

Manufacturer
medsource pharmaceuticals
Effective date
2019-12-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:02:33

Label at a glance#

ProductSenna
Active ingredientSENNOSIDES A AND B
Label structure14 sections

Indications and uses

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

Dosage and administration

take preferably at bedtime or as directed by a doctor if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease does until you are comfortable Age starting dosage maximum dosage adults children 12 years and over 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tabelts twice a day children 2 ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Stimulant Laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

  • laxative products for longer than 1 week 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 movements that continues 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 - 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 children. 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
  • if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease does until you are comfortable
Agestarting dosagemaximum dosage
adults children 12 years and over2 tablets once a day4 tablets twice a day
children 6 to under 12 years1 tablet once a day2 tabelts twice a day
children 2 to under 6 years1/2 tablet once a day1 tablet twice a day
children under 2 yearsask a doctorask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • each tablet contains: calcium 25 mg, sodium 2 mg (VERY LOW SODIUM)
  • store at 25°c (77°F) excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

Questions or comments?

OTC - QUESTIONS SECTION

Call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312935sennosides 8.6 MG Oral TabletPSN1
312935sennosides, USP 8.6 MG Oral TabletSCD1
312935sennosides A and B 8.6 MG Oral TabletSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-971-302025-01-30C16284748780-12cef2736-8cdc-d83d-e063-dadaa90ab31fSenna

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-971-30Senna30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-971SENNA (SENNOSIDES) TABLET [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20191231_9af0b870-0df3-9692-e053-2995a90ac5ab.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-048-01EA - Each69618-048a8353b4a-21ae-43ea-a248-c52728b22d1d12019-01-24

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45865-97145865-971-30
69618-048

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
SENNOSIDES A AND B1B5FPI42ENACTIB

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
9af0b870-0df4-9692-e053-2995a90ac5ab9af0b870-0df3-9692-e053-2995a90ac5ab2019-12-30WarningsExact identifier
spl id: 9af0b870-0df4-9692-e053-2995a90ac5ab
spl set id: 9af0b870-0df3-9692-e053-2995a90ac5ab

Reported adverse events (FAERS/openFDA)#

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