HEPAFLEX- virginiamycin powder

HepafleX by

Drug Labeling and Warnings

HepafleX by is a Animal medication manufactured, distributed, or labeled by ELANCO US. INC, Phibro Saude Animal Internacional Ltda. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

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

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

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

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

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

Hepaflex

Label

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEPAFLEX 
virginiamycin powder

Product Information
Product Type	VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 58198-1504
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VIRGINIAMYCIN (UNII: C49WS9N75L) (VIRGINIAMYCIN - UNII:C49WS9N75L)	VIRGINIAMYCIN	227 g  in 0.45 kg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
MINERAL OIL (UNII: T5L8T28FGP)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SOYBEAN OIL (UNII: 241ATL177A)
RICE BRAN (UNII: R60QEP13IC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58198-1504-1	25 kg in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA140998	10/15/2025

Labeler - ELANCO US. INC (966985624)

Registrant - ELANCO US. INC (966985624)

Establishment
Name	Address	ID/FEI	Business Operations
Phibro Saude Animal Internacional Ltda		907147578	api manufacture