FDA.reportPublic FDA data

SENNA

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Effective date
2018-04-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:59:11

Label at a glance#

ProductSENNA
Active ingredientSENNOSIDES A AND B
Label structure2 sections

Label contents#

Full prescribing information#

Repackaging Information

SPL UNCLASSIFIED SECTION

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count8.6 mg
10071610-054-65

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TNAphena Pharma Solutions - TN
Cookeville, TN 38506

20180427JH

PRINCIPAL DISPLAY PANEL - 8.6 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71610-054 - Sennosides (Senna) 8.6 mg - Rx Only
Bottle Label 8.6 mgBottle Label 8.6 mg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-054SENNA TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20180501_fb426ee8-b582-405f-9ded-71aea6bf2640.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-054-65EA - Each71610-054802881b4-eaa0-482f-ad02-45655d0d8f4b12018-12-13
0904-6434-59EA - Each0904-64349398fcfc-efa8-486c-89d4-2162872bcaba12015-07-20
0904-6434-80EA - Each0904-64345ffb06d6-ae2f-4c73-beae-fa2151ad841012015-07-20

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71610-05471610-054-65
0904-6434

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SENNOSIDES A AND B1B5FPI42ENACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT

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
3635aec1-4bf6-8177-e063-6294a90a8396fb426ee8-b582-405f-9ded-71aea6bf26402025-05-28Exact identifier
spl set id: fb426ee8-b582-405f-9ded-71aea6bf2640

Reported adverse events (FAERS/openFDA)#

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