Senna

Manufacturer
Advance Pharmaceutical Inc. | Time Cap Laboratories, Inc.
Effective date
2017-10-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:52:50

Label at a glance#

ProductSenna
Active ingredientSENNOSIDES A AND B
Label structure9 sections

Indications and uses

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

Dosage and administration

take preferably at bedtime or as directed by a doctor  a ge  starting dosage  maximum dosage  adults and children 12 years of age or older  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  1/2 tablet once a day  1 tablet twice a day  children under 2 years  ask a doctor  ask a doctor

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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
 a ge
 starting dosage
 maximum dosage
 adults and children 12 years of age or older
 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
 1/2 tablet once a day
 1 tablet twice a day
 children under 2 years
 ask a doctor
 ask a doctor

Other information

OTHER SAFETY INFORMATION

  • each tablet contains: calcium 25 mg, sodium 2mg (very low sodium)
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

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 631-981-4600, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 17714-122-01

Senna 8.6mg

senna 8.6mgsenna 8.6mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312935sennosides 8.6 MG Oral TabletPSN2
312935sennosides, USP 8.6 MG Oral TabletSCD2
312935sennosides A and B 8.6 MG Oral TabletSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17714-122-012023-01-30C16284748780-1f386c649-d404-0266-e053-dadaa90a7c1aSenna 8.6mg tabs

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17714-122-01Senna100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17714-122SENNA (SENNOSIDES) TABLET [ADVANCE PHARMACEUTICAL INC.]2Legacy NDC, 1 package rows20171031_18d7bd07-f3a3-4140-bfb6-4e734f9b6649.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17714-12217714-122-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
5cc98885-35c9-38b3-e053-2991aa0a8f7618d7bd07-f3a3-4140-bfb6-4e734f9b66492017-10-30WarningsExact identifier
spl id: 5cc98885-35c9-38b3-e053-2991aa0a8f76
spl set id: 18d7bd07-f3a3-4140-bfb6-4e734f9b6649

Reported adverse events (FAERS/openFDA)#

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