FDA.reportPublic FDA data

Senna Laxative

Manufacturer
Pioneer Life Sciences, LLC
Effective date
2025-03-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:56:53

Label at a glance#

ProductSenna Laxative
Active ingredientSENNOSIDES
Label structure14 sections

Indications and uses

relieves occasional constipation (irregularity). generally prodcues a 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 & 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 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 prodcues a 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 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 Poison Control Center (1-800-222-1222) right away. 

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Take preferably at bedtime or as directed by a doctor.

age

starting dosage

maximum dosage

adults & 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

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

  • store at 20-25°C (68-77°F) excursions permitted between15°-30°C (59°-86°F)
  • each tablet contains: Calcium 25 mg & sodium 3 mg

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Lactose Monohydrate, Microcrysatlline Cellulose, Crosspovidone XL 10, PVP K30, Magnesium Stearate. Aqua Dry Clear contains: Polyvinyl alcohol, Polysorbate 80, Macrogol/PEG, Talc

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call + 1-732-994-2808 or email support@gencare.health

NDC 72090-041-01 (300ct Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL0244-01 GC Senna Natural Relief Sennosides 8.6mg 300ct_page-0001PL0244-01 GC Senna Natural Relief Sennosides 8.6mg 300ct_page-0001

NDC 72090-041-02 (600ct Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL0245-01 Senna Natural Relief Sennosides 8.6mg 600ctPL0245-01 Senna Natural Relief Sennosides 8.6mg 600ct

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72090-041-01Senna Laxative300 in 1 BOTTLETABLET3002
72090-041-02Senna Laxative600 in 1 BOTTLETABLET6002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72090-041SENNA LAXATIVE TABLET [PIONEER LIFE SCIENCES, LLC]2Current NDC, 2 package rows20250309_cebc1e10-7dc7-489f-a8f6-dac88a0f2b81.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72090-04172090-041-01, 72090-041-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SENNOSIDES3FYP5M0IJXACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
POVIDONE K30U725QWY32XIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYVINYL ALCOHOL532B59J990IACT
POLYSORBATE 806OZP39ZG8HIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
TALC7SEV7J4R1UIACT

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 LaxativeSENNA LAXATIVEPioneer Life Sciences, LLCcebc1e10-7dc7-489f-a8f6-dac88a0f2b812025-03-06WarningsExact identifier
ndc (package): 72090-041-01
ndc (package): 72090-041-02
ndc (product): 72090-041
ndc11 (package): 72090004101
ndc11 (package): 72090004102
spl id: c25374a8-66ae-42bc-b6eb-2f37aefb1de5
spl set id: cebc1e10-7dc7-489f-a8f6-dac88a0f2b81

Reported adverse events (FAERS/openFDA)#

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