HepafleX - ELANCO US. INC

Manufacturer
ELANCO US. INC
Effective date
2026-09-10
Label type
VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-09-12 01:01:03

Label at a glance#

ProductHepafleX
Active ingredientVIRGINIAMYCIN
Label structure2 sections

Label contents#

Full prescribing information#

WARNINGS AND PRECAUTIONS SECTION

To be mixed in cattle feed

Active Drug Ingredient

DESCRIPTION SECTION

Virginiamycin: 50%

(Contains 227 g virginiamycin activity per lb)

CAUTION:

PRECAUTIONS SECTION

CAUTION: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

Inert ingredients:

SPL UNCLASSIFIED SECTION

Calcium carbonate, carboxymethylcellulose, mineral oil

SPL UNCLASSIFIED SECTION

Important: Must be diluted in feed before use

Follow Directions For Use

Approved by FDA under NADA # 140-998

102-8409-1

HepafleX, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. 

NET WEIGHT: 55 lb (25kg)

Distributed by:

Elanco US Inc.

Indianapolis, IN  46221

Made in Canada

For use in complete feeds for cattle fed in confinement for slaughter Directions for Use

DOSAGE & ADMINISTRATION SECTION

 Cattle fed in confinement for slaughter Virginiamycin required mg/hd/day Virginiamycin (g/tons) of complete feed (90% dry matter basis)
 Reduction of incidence of liver abscesses 85-240       13.5-16.0
Caution: Not for use in animals intended for breeding.

Mixing Directions


Type B medicated feed for cattle fed in confinement for slaughter - Thoroughly mix 4.4 lb of HepafleX Type A Medicated Article per ton of Type B medicated feed to provide 1000 g/ton virginiamycin.
An intermediate blending step, consistent with the mixing equipment specifications, should be performed to ensure adequate mixing.


Type C medicated feed
The Type B medicated feed must be diluted to a Type C medicated feed before being fed. Prepare a Type B medicated feed as described above. Thoroughly mix the Type B medicated feed to make 1 ton of Type C medicated feed to provide 13.5–16.0g of virginiamycin per ton of complete feed on a 90% dry matter basis using the examples provided in Table 1.

Table 1. Type C medicated feed

lb of a 1,000 g/ton Type B
medicated feed per ton of complete feed
 Virginiamycin concentration in complete feed
90% dry matter basis (g/ton)
 27 13.5
 32 16.0

 Feed continuously as sole ration

STORAGE AND HANDLING SECTION

Store At Or Below 25°C (77°F), Excursions Permitted Up To 40°C (104°F)
Close container after use

SPL UNCLASSIFIED SECTION

SKU:
LOT No.:
DATE OF EXPIRATION:
Distributed by:
Elanco US Inc.
Indianapolis, IN 46221
Made in Canada.

INDICATIONS & USAGE SECTION

Not For Human Use
Restricted Drug (California) – Use Only as Directed

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

HepafleXHepafleX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58198-150458198-1504-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-09-26full-release2026-06-01 02:46:02

Reported adverse events (FAERS/openFDA)#

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