FDA.reportPublic FDA data

Senna

Manufacturer
Reliable 1 Laboratories LLC
Effective date
2025-01-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:52:55

Label at a glance#

ProductSenna
Active ingredientSENNOSIDES A AND B
Label structure14 sections

Indications and uses

relieve 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 do not exceed maximum dosage 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 doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Stimulant Laxative

Uses

INDICATIONS & USAGE SECTION

  • relieve occasional constipation (irregularity)
  • this product generally produces a bowel movement in 6 to 12 hours

Warnings

WARNINGS SECTION

Do not use

  • Lasative 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 habits 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 of children. In case of overdose, get medical help or contact a Posion Control Center right away.

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal sillicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose

Questions or comments?

OTC - QUESTIONS SECTION

Call 516-341-0666

8:30am-4:30pm ET. Mon-Fri

Directions

DOSAGE & ADMINISTRATION SECTION

take preferably at bedtime or as directed by a doctor

do not exceed maximum dosage

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 doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69618-064-01

Reliable-1 Laboratories®

Senna

Sennosides 8.6 mg

Natural Vegetable Laxative

100 Tablets

*Compare to the Active Ingredient in SENOKOT®

Rev 01 Reliable1 Senna 100ct JPGRev 01 Reliable1 Senna 100ct JPG

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312935sennosides 8.6 MG Oral TabletPSN4
312935sennosides, USP 8.6 MG Oral TabletSCD4
312935sennosides A and B 8.6 MG Oral TabletSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69618-064-012023-08-21C16284748780-1f386c64a-12f3-0266-e053-dadaa90a7c1aSenna 8.6mg
69618-064-012023-01-30C16284748780-1f386c64a-12f3-0266-e053-dadaa90a7c1aSenna 8.6mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-064-01Senna100 in 1 BOTTLETABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-064SENNA (SENNOSIDES) TABLET [RELIABLE 1 LABORATORIES LLC]4Current NDC, Legacy NDC, 1 package rows20250117_ae46a611-20f2-74c8-e053-2995a90a32ce.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-064-01EA - Each69618-0649f21fc3d-1bee-49ed-9c25-df5c6414ba7512021-03-02

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
69618-06469618-064-01

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
SENNOSIDES A AND B1B5FPI42ENACTIB
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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
SennaSENNOSIDESReliable 1 Laboratories LLCae46a611-20f2-74c8-e053-2995a90a32ce2025-01-15WarningsExact identifier
ndc (package): 69618-064-01
ndc (product): 69618-064
ndc11 (package): 69618006401
spl id: 2bc82d20-1476-46c7-e063-6394a90a0d44
spl set id: ae46a611-20f2-74c8-e053-2995a90a32ce

Reported adverse events (FAERS/openFDA)#

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