FDA.reportPublic FDA data

Laxative Senna

Manufacturer
TOPCO ASSOCIATES LLC
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:52:17

Label at a glance#

ProductLaxative Senna
Active ingredientSENNOSIDES
Label structure10 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 age starting dosage maximum dosage adults and 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

Storage and handling

• each tablet contains: calcium 27.93 mg • store between 20-25 °C (68-77 °F)

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
• laxative products for longer than 1 week unless directed by a doctor

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

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,

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 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 and over2 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

Other information:

STORAGE AND HANDLING SECTION

• each tablet contains: calcium 27.93 mg
• store between 20-25 °C (68-77 °F)

Inactive ingredients:

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, silicon dioxide, talc, triacetin

Questions or comments:

OTC - QUESTIONS SECTION

Call: 1-888-423-0139

SPL UNCLASSIFIED SECTION

+TopCare® health

COMPARE TO SENOKOT® ACTIVE INGREDIENT*

Vegetable Laxative

Gentle, Overnight Relief of Constipation

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

©TOPCO STVA0121

topcare@topco.com

www.topcarebrand.com

This TopCare® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.

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

KEEP OUTER CARTON FOR COMPLETE PRODUCT INFORMATION

*This product is not manufactured or distributed by Purdue Products L.P., distributor of Senokot®.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Laxative SennaLaxative Senna

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312935sennosides 8.6 MG Oral TabletPSN3
312935sennosides, USP 8.6 MG Oral TabletSCD3
312935sennosides A and B 8.6 MG Oral TabletSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-984-01Laxative Senna100 in 1 BOTTLETABLET, COATED1003
36800-984-01Laxative Senna1 in 1 CARTONTABLET, COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-984LAXATIVE SENNA (SENNOSIDES) TABLET, COATED [TOPCO ASSOCIATES LLC]3Current NDC, Legacy NDC, 2 package rows20250112_ca88c4b8-94af-43c6-9394-e4687804ffd8.zip

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
36800-98436800-984-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SENNOSIDES3FYP5M0IJXACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TALC7SEV7J4R1UIACT
TRIACETINXHX3C3X673IACT

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
Laxative SennaSENNOSIDESTOPCO ASSOCIATES LLCca88c4b8-94af-43c6-9394-e4687804ffd82025-01-01WarningsExact identifier
ndc (package): 36800-984-01
ndc (product): 36800-984
ndc11 (package): 36800098401
spl id: 3f0719a4-b9c2-4209-8068-7eb5ded1ab12
spl set id: ca88c4b8-94af-43c6-9394-e4687804ffd8

Reported adverse events (FAERS/openFDA)#

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