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#
Contacts and useful links#
Label contents#
Full prescribing information#
WARNINGS AND PRECAUTIONS SECTION
To be mixed in cattle feed
Active Drug Ingredient
Virginiamycin: 50%
(Contains 227 g virginiamycin activity per lb)
CAUTION:
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:
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
| 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
Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| baf7f49c-75b6-496b-a00e-8e766a8e4f03 | Product name | 1 | 20210127 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
Products#
Every source-derived product name is available through these pages.
- HepafleX
- virginiamycin
- CALCIUM CARBONATE
- MINERAL OIL
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- SOYBEAN OIL
- RICE BRAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58198-1504 | 58198-1504-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| VIRGINIAMYCIN | C49WS9N75L | ACTIB |
| CALCIUM CARBONATE | H0G9379FGK | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | K679OBS311 | IACT |
| SOYBEAN OIL | 241ATL177A | IACT |
| RICE BRAN | R60QEP13IC | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2025-09-26 | full-release | 2026-06-01 02:46:02 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
