FDA.reportPublic FDA data

Senna Tablets Natural Vegitable Lexative

Manufacturer
Akron Pharma Inc.
Effective date
2023-03-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:54:34

Label at a glance#

ProductSenna
Active ingredientSENNOSIDES
Label structure10 sections

Indications and uses

relieves occasional constipation (irregularity) generally causes 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 older 2 tablets once a day 4 tablets twice a day Children 6 to under 12 years of age 1 tablet once a day 2 tablets twice a day Children 2 to under 6 years of age 1/2 tablet once a day 1 tablet twice a day Children under 2 years of age ask a doctor ask a doctor

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally causes a bowel movement in 6-12 hours

WARNINGS SECTION

Do not use

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

Do not use

OTC - DO NOT USE SECTION

laxative products for longer than one 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 care professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OVERDOSAGE 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 and older

2 tablets

once a day

4 tablets

twice a day

Children 6 to under

12 years of age

1 tablet

once a day

2 tablets

twice a day

Children 2 to under

6 years of age

1/2 tablet

once a day

1 tablet

twice a day

Children under

2 years of age

ask a doctor

ask a doctor

Other information

OTHER SAFETY INFORMATION

  • Each tablet contains: Calcium 14 mg
  • Store between 15º to 30ºC (59 to 86F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

microcrystaline cellulose, dicalcium phosphate, sodium starch glycolate, croscarmellose sodium, hypromellose, povidone, collodial silicon dioxide, megnesium stearate. 

Questions or comments?

OTC - QUESTIONS SECTION

1-(877) 255-6999

SPL UNCLASSIFIED SECTION

Tamper Evident:

Do not use if imprinted inner safety seal is torn or missing.

This product is not manufactured or distributed by Purdue Products L.P.,

Owner of the registered trademark Senokot®

Manufactured for:

Akron Pharma Inc

Fairfield, NJ 07004

www.akronpharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UDUD

8.68.6

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-8245-12025-01-30C16284748780-1f386c64a-05fe-0266-e053-dadaa90a7c1aSenna Tablets Natural Vegitable Lexative
71399-8245-22025-01-30C16284748780-1f386c64a-05fe-0266-e053-dadaa90a7c1aSenna Tablets Natural Vegitable Lexative
71399-8245-32025-01-30C16284748780-1f386c64a-05fe-0266-e053-dadaa90a7c1aSenna Tablets Natural Vegitable Lexative
71399-8245-12023-03-26C16284748780-1f386c64a-05fe-0266-e053-dadaa90a7c1aSenna Tablets Natural Vegitable Lexative
71399-8245-22023-03-26C16284748780-1f386c64a-05fe-0266-e053-dadaa90a7c1aSenna Tablets Natural Vegitable Lexative
71399-8245-12023-01-30C16284748780-1f386c64a-05fe-0266-e053-dadaa90a7c1aSenna Tablets Natural Vegitable Lexative
71399-8245-22023-01-30C16284748780-1f386c64a-05fe-0266-e053-dadaa90a7c1aSenna Tablets Natural Vegitable Lexative

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-8245-1Senna100 in 1 BOTTLETABLET, FILM COATED1002
71399-8245-2Senna1000 in 1 BOTTLETABLET, FILM COATED10002
71399-8245-3Senna1 in 1 PACKETTABLET, FILM COATED12
71399-8245-3Senna100 in 1 PACKAGETABLET, FILM COATED1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-8245SENNA (SENNOSIDES) TABLET, FILM COATED [AKRON PHARMA INC.]2Legacy NDC, 4 package rows20230327_d5f119ac-45c3-4a97-9aef-edb87d7d2b8e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-8245-1EA - Each71399-8245c5785caa-a79a-4c3d-8023-1100117a9a7a12021-06-02
71399-8245-2EA - Each71399-824575b8f7fe-bd11-4545-a96a-b511c71141ad12021-06-02
71399-8245-3EA - Each71399-8245c72b9222-54df-47bc-8fca-f7947171e88012023-04-07

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
71399-824571399-8245-1, 71399-8245-2, 71399-8245-3

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
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSL11K75P92JIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POVIDONEFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
SENNOSIDES3FYP5M0IJXACTIB

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
55b1f357-372b-48dd-a525-7a7c5e340e8fd5f119ac-45c3-4a97-9aef-edb87d7d2b8e2023-03-18WarningsExact identifier
spl id: 55b1f357-372b-48dd-a525-7a7c5e340e8f
spl set id: d5f119ac-45c3-4a97-9aef-edb87d7d2b8e

Reported adverse events (FAERS/openFDA)#

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