ROFENAID 40- sulfadimethoxine and ormetoprim powder 
Zoetis Inc.

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RofenAid 40

DESCRIPTION

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

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

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

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

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

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

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

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.

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

Bag label
ROFENAID 40 
sulfadimethoxine and ormetoprim powder
Product Information
Product TypeVFD TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:54771-1446
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFADIMETHOXINE (UNII: 30CPC5LDEX) (SULFADIMETHOXINE - UNII:30CPC5LDEX) SULFADIMETHOXINE113.5 g  in 0.45 kg
ORMETOPRIM (UNII: M3EFS94984) (ORMETOPRIM - UNII:M3EFS94984) ORMETOPRIM68.1 g  in 0.45 kg
Product Characteristics
ColorBROWN (beige to light tan) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54771-1446-022.68 kg in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA04020912/01/2018
Labeler - Zoetis Inc. (828851555)
Establishment
NameAddressID/FEIBusiness Operations
Zoetis LLC069370112MANUFACTURE

Revised: 4/2020
Document Id: 1a689074-ea08-49b4-80ad-7f1f56b3ba3f
Set id: f03bea2c-43c3-4963-a9bc-c8a09b708d76
Version: 8
Effective Time: 20200407
 
Zoetis Inc.