SULFADIMETHOXINE 107G- sulfadimethoxine sodium powder, for solution

Sulfadimethoxine 107g by

Drug Labeling and Warnings

Sulfadimethoxine 107g by is a Animal medication manufactured, distributed, or labeled by MWI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

NDC 13985-717-10

VetOne Sulfadimethoxine 107g
Soluble Powder
Antibacterial

Each packet contains 3.34 oz. (94.6 g) sulfadimethoxine in the form
of the soluble sodium salt and disodium edetate.

CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Restricted Drug (California) - Use Only as Directed.
Not for Human Use.

ANADA #200-238 APPROVED BY FDA

For Broiler and Replacement Chickens Only - Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

For Meat-producing Turkeys Only - Use for the treatment of disease outbreaks of coccidiosis, and fowl cholera.

For Dairy Calves, Dairy Heifers, and Beef Cattle - Use for the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Sphaerophorus necrophorus sensitive to sulfadimethoxine.

Net Contents: 3.77 oz (107g)

Distributed by: MWI

Boise, ID 83705

www.VetOne.net

V1 501103    Label Rev. 03/17

DOSAGE & ADMINISTRATION

                                                               VetOne SULFADIMETHOXINE 107g

                                                                                        Soluble  Powder

Dosage and Administration:                                                                                                                                                                        

     Species                     Concentration                Use of Directions                                                                                                            

   Chickens                    0.05%                        Contents of package to 50 gal of water

   Turkeys                     0.025%                       Contents of packet to 100 gal of water                                                                                  

Automatic Proportioners: To make stock solution, add contents of 5 packets to 2 gal of water for chickens and to 4 gal of water for turkeys.
Set proportioner to feed at a rate of  1 fl oz stock solution per gal of water.
Treatment Period: 6 consecutive days                                                                                                                                                        

Dairy Calver, Dairy Heifers, and Beef Cattle

Dosage: 25 mg/lb first day following 12.5 mg/lb/day for 4 days

                                                             Sulfadimethoxine in Water                                                                                                             

                                                                  Water Consumption                                   

                            Amount of Stock Solution       (Summer)*                                  (Winter)*

                                    for Cattle*               1 gal/100 lb body weight**        1 gal/150 lb body weight**                                              

                                     1 qt                                       10 gal                                          7 gal
First Day Add            2 qt                                       20 gal                                        14 gal
                                     1 gal                                     40 gal                                         28 gal

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                                     1 qt                                       20 gal                                         14 gal
Next 4 Days Add        2 qt                                       40 gal                                         28 gal
                                     1 gal                                     80 gal                                         56 gal                                    

*Note: Make a cattle stock solution by adding 1 packet of VetOne®Sulfadimethoxine 107g Powder to 1 gal of water.
*Twenty fl oz cattle stock solution will medicate 1-600 lb animal initially or 2-600 lb animals on maintenance dose. Contents of packet will medicate 6-600 lb animals initially or 12-600 lb animals on maintenance dose.
** This dosage recommendation is based on a water consumption of 1 gal per 100 lb of body weight per day, the expected water consumption rate for summer. Water consumption during cold months (winter) may drop markedly (30%-40%).  Accordingly, adjustments must be made in the dilution rates to compensate for this and insure proper drug intake.
For treatment of individual cattle, VetOne® Sulfadimethoxine 107g Powder stock solution for cattle may be given as a drench.
Treatment Period: 5 consecutive days

WARNINGS AND PRECAUTIONS

Caution: Chickens and Turkeys - If animals show no improvement within 5 days, discontinue treatment and reevaluate diagnosis. Prepare a fresh stock solution daily.  Handle the recommended dilutions (chickens 0.05% and turkeys 0.025%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication.
Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.
Cattle - During treatment period, make certain that animals maintain adequate water intake. If animals show no improvement within 2 or 3 days, reevaluate diagnosis. Treatment should not be continued beyond 5 days.

Warning:
Chickens and Turkeys - Withdraw 5 days before slaughter. Do not administer to chickens over 16 weeks (112 days) of age or to turkeys over
24 weeks (168 days) of age.
Cattle - Withdraw 7 days before slaughter. For dairy calves, dairy heifers and beef cattle only.
A withdrawal period has not been established for this product in pre-ruminating calves.
Do Not Use in Calves to be Processed For Veal

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SULFADIMETHOXINE 107G 
sulfadimethoxine sodium powder, for solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 13985-717
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFADIMETHOXINE SODIUM (UNII: 49DG2B481W) (SULFADIMETHOXINE - UNII:30CPC5LDEX)	SULFADIMETHOXINE SODIUM	94.6 g  in 107 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13985-717-10	107 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200238	07/01/2016

Labeler - MWI (019926120)