FDA.reportPublic FDA data

Senna

Manufacturer
AACE PHARMACEUTICALS, INC.
Effective date
2024-11-07
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 20:49:30

Label at a glance#

ProductSenna
Active ingredientSENNOSIDES
Label structure9 sections

Indications and uses

relieves occasional constipation (irregularity) this product generally produces a bowel movement in 6 to 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 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 docto

Storage and handling

each tablet contains: calcium 4 mg, sodium 3 mg store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Senna Tablets

Sennosides 8.6 mg

AACE Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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)
  • this product generally produces a bowel movement in 6 to 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
agestarting dosagemaximum dosage
adults and children 12 years of age or older2 tablets once a day4 tablets twice a day
children 6 to under 12 years1 tablet once a day2 tablets 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 docto

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 4 mg, sodium 3 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​†Compare to the active ingredient in Senokot®

Senna Tablets

Sennosides 8.6 mg

Natural Vegetable Laxative

Gentle, Overnight Relief of Constipation

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

Manufactured by:

AACE Pharmaceuticals, Inc. Fairfield, NJ 07004

aacepharma.com

†This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot®.

Senna 1000Senna 1000

NDC 71406-105-01NDC 71406-105-01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71406-105-012021-10-28C16284748780-1ba0f9c33-283c-a910-e053-dadaa90a0b8591320afc-2eec-692f-e053-2a95a90a3616
71406-105-102021-10-28C16284748780-1ba0f9c33-283c-a910-e053-dadaa90a0b8591320afc-2eec-692f-e053-2a95a90a3616
71406-105-012021-01-29C16284748780-1ba0f9c33-283c-a910-e053-dadaa90a0b8591320afc-2eec-692f-e053-2a95a90a3616
71406-105-102021-01-29C16284748780-1ba0f9c33-283c-a910-e053-dadaa90a0b8591320afc-2eec-692f-e053-2a95a90a3616

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71406-105-01EA - Each71406-1051c4ca8dd-59d6-498a-a0fb-024932d4ae2212021-11-09
71406-105-10EA - Each71406-10553afb42b-8473-41e5-9bea-2a02df8f9ae412021-11-09

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71406-10571406-105-01, 71406-105-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
SENNOSIDES3FYP5M0IJXACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

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
351e27fe-fe0b-a533-e063-6294a90abe2791320afc-2eec-692f-e053-2a95a90a36162025-05-14WarningsExact identifier
spl set id: 91320afc-2eec-692f-e053-2a95a90a3616

Reported adverse events (FAERS/openFDA)#

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