FDA.reportPublic FDA data

Senna 8.6mg Tablets

Manufacturer
PHARMAMED USA INC | PHARBEST PHARMACEUTICALS, INC.
Effective date
2024-06-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:22:17

Label at a glance#

ProductSenna-Tabs
Active ingredientSENNOSIDES
Label structure13 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 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 ½ 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 8.6mg

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

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 the 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 an overdose, get medical help or contact a Poison Control Center right away (1 800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • take preferably at bedtime or as directed by a doctor
agestarting dosagemaximum dosage
adults and children 12 years and over2 tablets once a day

4 tablets twice a day

children 6 to under 12 years1 tablet once a day2 tablets twice a day

children 2 to under 6 years

 ½ tablet once a day

1 tablet twice a day

children under 2 yearsask a doctorask a doctor

Other information

OTHER SAFETY INFORMATION

  • each tablet contains: calcium 31 mg, sodium 2 mg, Very Low Sodium
  • store at 20º -25ºC (68º-77ºF); excursions permitted between 15º -30º C (59º-86º F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, talc, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

(866) 562-2756 (Mon - Fri 8 AM to 4 PM EST)

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARMAMED

NDC 84289-363-01

Manufactured in the USA

Natural Vegetable Laxative Ingredient

Senna

100 TABLETS

8.6 mg each

*Compare to the active ingredient of Senokot

Label ImageLabel Image

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84289-363-01Senna-Tabs100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84289-363SENNA-TABS (SENNA 8.6MG) TABLET, FILM COATED [PHARMAMED USA INC]21 package rows20241001_1b2fba6c-6af1-e229-e063-6394a90a5616.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
84289-36384289-363-01
73057-363

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
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
MAGNESIUM STEARATE70097M6I30IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSL11K75P92JIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
TRIACETINXHX3C3X673IACT
SENNOSIDES3FYP5M0IJXACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna-TabsSENNA 8.6MGUlai Health LLC485129a0-8340-4f61-be51-5abff5032b8d2025-01-20WarningsExact identifier
ndc (product): 73057-363
1bdfb7dd-bf92-3b34-e063-6394a90a05b21b2fba6c-6af1-e229-e063-6394a90a56162024-06-27WarningsExact identifier
spl id: 1bdfb7dd-bf92-3b34-e063-6394a90a05b2
spl set id: 1b2fba6c-6af1-e229-e063-6394a90a5616

Reported adverse events (FAERS/openFDA)#

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