Rofenaid 40

Manufacturer
Zoetis Inc. | Zoetis LLC
Effective date
2020-04-07
Label type
VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 02:40:44

Label at a glance#

ProductRofenaid 40
Active ingredientSULFADIMETHOXINE, ORMETOPRIM
Label structure10 sections

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

RofenAid
40

Sulfadimethoxine & Ormetoprim

Type A Medicated Article

Antibacterial

Anticoccidial

For use in broiler, replacement (breeder and layer) chickens, turkeys, ducks and chukar partridges only.

Active Drug Ingredients

SPL UNCLASSIFIED SECTION

Sulfadimethoxine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113.5 grams per pound (25%),

Ormetoprim . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68.1 grams per pound (15%)

in a carrier suitable for incorporation in feed.

For use in manufacturing medicated feeds only

Chickens

SPL UNCLASSIFIED SECTION

Broiler and replacement (breeder and layer) chickens

Indications:

As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina,  E. maxima, E. brunetti and E. mivati; as an aid in the prevention of bacterial infections caused by Haemophilus gallinarum (infectious coryza), Escherichia coli (colibacillosis) and Pasteurella  multocida (fowl cholera).

Use directions:

Add 1 lb of RofenAid 40 to one ton of feed to provide 0.02% (113.5 g/ton [0.0125%] sulfadimethoxine and 68.1 g/ton [0.0075%] ormetoprim) concentration in feed. Feed continuously as the sole ration.

Warning:

Do not feed to chickens over 16 weeks (112 days) of age.

Turkeys

SPL UNCLASSIFIED SECTION

Indications:

As an aid in the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis; for the prevention of bacterial infections caused by Pasteurella multocida (fowl cholera).

Use directions:

Add 1/2 lb of RofenAid 40 to one ton of feed to provide 0.01% (56.75 g/ton [0.00625%] sulfadimethoxine and 34.05 g/ton [0.00375%] ormetoprim) concentration in feed. Feed continuously as the sole ration.

Ducks

SPL UNCLASSIFIED SECTION

Ducks, including breeding ducks

 Indications:

As an aid in the control of bacterial infections due to Pasteurella multocida (fowl cholera) in ducks including breeding ducks.

Use directions:

Add 2 lbs of RofenAid 40 to one ton of feed to provide 0.04% (227 g/ton [0.025%] sulfadimethoxine and 136.2 g/ton [0.015%] ormetoprim) concentration in feed. Medication should be started at the first signs of infection. Feed for 7 days as the sole ration.

 

Ducks

Indications:

As an aid in the control of bacterial infections due to Escherichia coli, Riemerella anatipestifer (strains 2, 3 & 4) and severe challenge of P. multocida (fowl cholera).

Use directions:

Add 4 lbs of RofenAid 40 to one ton of feed to provide 0.08% (454 g/ton [0.050%] sulfadimethoxine and 272.4 g/ton [0.030%] ormetoprim) concentration in feed. Medication should be started at the first signs of infection. Feed for 7 days as the sole ration.

Caution:

Not for breeding ducks. The safety of feeding sulfadimethoxine and ormetoprim at levels higher than 0.025% and 0.015%, respectively, in breeding ducks has not been established.

Chukar Partridges

SPL UNCLASSIFIED SECTION

Indications:

For the prevention of coccidiosis caused by Eimeria kofoidi and E. legionensis.

Use directions:

Add 1 lb of RofenAid 40 to one ton of feed to provide 0.02% (113.5 g/ton [0.0125%] sulfadimethoxine and 68.1 g/ton [0.0075%] ormetoprim) concentration in feed. Feed continuously as the sole ration to young birds up to 8 weeks of age.

Caution:

The safety of feeding RofenAid 40 to breeding stock has not been established.

Warning

WARNINGS SECTION

Do not feed to turkeys and ducks producing eggs for food. Withdraw 5 days prior to slaughter of broiler and replacement chickens, turkeys and ducks.

Note

SPL UNCLASSIFIED SECTION

Manufacture of Type B or C feeds from this product requires a Medicated Feed Mill License.

Labels for feeds containing RofenAid 40 must contain appropriate indications, limitations and warnings as well as required feed ingredient information.

SPL UNCLASSIFIED SECTION

Restricted Drug (California) - Use only as directed. Not for human use.
Approved by FDA under NADA # 040-209
Store below 25°C (77°F), excursions permitted to 37°C (99°F).

zoetis

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

Product of China

10010602

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bag label
Bag label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54771-1446-0Rofenaid 4022.68 kg in 1 BAGPOWDER22.688

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54771-1446ROFENAID 40 (SULFADIMETHOXINE AND ORMETOPRIM) POWDER [ZOETIS INC.]81 package rows20200409_f03bea2c-43c3-4963-a9bc-c8a09b708d76.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54771-144654771-1446-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SULFADIMETHOXINE30CPC5LDEXACTIB
ORMETOPRIMM3EFS94984ACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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