SENEXON

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Effective date
2018-05-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:54:16

Label at a glance#

ProductSENEXON
Active ingredientSENNOSIDES A and B
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet) Sennosides 8.6mg

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking any other drug.  Take this product tow or more hours before or after other drugs.  Laxatives may affect how other drugs work.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks.

WARNINGS SECTION

Do not use for longer than one week, when abdominal pain, nausea or vomiting are present.

OTC - STOP USE SECTION

Stop use and ask a doctor if: you have rectal bleeding; you fail to have a bowel movement after use of this product.  These may indicate a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - PURPOSE SECTION

uses

relieves occasional constipation(irregularity);generally causes bowel movement in 6-12 hours.

OTC - QUESTIONS SECTION

1800 645-2158 9 am - 5 pm Monday - Friday

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.

INACTIVE INGREDIENT SECTION

Inactive Ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, minerol  oil

DOSAGE & ADMINISTRATION SECTION

Dosage and Administration

Adults and children 12 years and over - 2 tablets once a day - maximum dosage - 4 tablets twice a day

Children 6 to under 12 years - 1 tablet once a day maximum dosage - 2 tablets twice a day

children 2 to under 6 years - 1/2 tablet once a day - maximum dosage - 1 tablet twice a day

INDICATIONS & USAGE SECTION

Relieves occasional constipation

Generally produces bowel movement in 6-12 hours

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
10071610-058-65

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

20180514JH

PRINCIPAL DISPLAY PANEL - 8.6 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71610-058 - Sennosides (Senna) 8.6 mg
Bottle Label 8.6 mgBottle Label 8.6 mg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-058SENEXON (SENNA) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20180620_18c77552-9e65-4e73-9e41-59f91075ce94.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-058-65EA - Each71610-0583635cafc-b9e2-44c2-972c-5c0a351ef8b512018-09-05
0536-5904-01EA - Each0536-590484126d7e-b826-4446-a769-84be30acc72512012-07-24
0536-5904-10EA - Each0536-59046d31bad8-e482-4476-87f4-35cc06ef188a12012-07-24

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71610-05871610-058-65
0536-5904

Ingredients#

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

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

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
73cf2c07-fa54-4859-8d5b-4117ecb94bc618c77552-9e65-4e73-9e41-59f91075ce942025-05-29WarningsExact identifier
spl set id: 18c77552-9e65-4e73-9e41-59f91075ce94

Reported adverse events (FAERS/openFDA)#

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