SULFADIMETHOXINE CONCENTRATED SOLUTION 12.5%- sulfadimethoxine concentrated solution 12.5% solution 
Aspen Veterinary Resources Ltd

----------

Sulfadimethoxine Concentrated Solution 12.5%

NDC: 46066-081-11

Sulfadimethoxine Concentrated Solution 12.5%

ANTIBACTERIAL

for Use in Drinking Water

For Oral Use in Chickens, Turkeys, and Cattle

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

Approved by FDA under ANADA # 200-165

PROTECT FROM LIGHT

NET CONTENTS: 1 Gallon (3.785 L)

INDICATIONS

BROILER AND REPLACEMENT CHICKENS: Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

MEAT PRODUCING TURKEYS: Use for the treatment of disease outbreaks of coccidiosis and fowl cholera.

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, calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

PRECAUTIONS

Store at controlled room temperature 20° to 25°C (68° to 77°F), excursions permitted from 15° to 30°C (59° to 86°F). If freezing occurs, thaw before using. Protect from light; direct sunlight may cause discoloration. Freezing or discoloration does not a­ffect potency. Prepare a fresh stock solution daily.

CHICKENS AND TURKEYS: If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. 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, re-evaluate diagnosis. Treatment should not be continued beyond 5 days.

FOR USE IN ANIMALS ONLY

NOT FOR USE IN HUMANS

KEEP OUT OF REACH OF CHILDREN

take-time.jpg

RESIDUE WARNINGS

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

Restricted Drug (California) – Use Only as Directed

DO NOT SLAUGHTER COW FOR 7 DAYS AFTER LAST TREATMENT

Dosage and Administration

Chickens and Turkeys
  Treatment Period: 6 consecutive days
  Recommended Concentrations: Chickens – 0.05%; Turkeys – 0.025%

  Chickens

Add 1 fl oz (30 mL) to 2 gallons of drinking water or 25 fl oz to 50 gallons of drinking water.

  Turkeys

Add 1 fl oz (30 mL) to 4 gallons of drinking water or 25 fl oz to 100 gallons of drinking water.

  Automatic Proportioners* Stock Solution

To make 2 gallons of Stock Solution use:

  Chickens

Add 1 gallon of Sulfadimethoxine Concentrated Solution 12.5% to 1 gallon of water

  Turkeys

Add 2 qts of Sulfadimethoxine Concentrated Solution 12.5% to 6 qts of water

*Set proportioner to a feed rate of 1 fl oz (30 mL) of Sulfadimethoxine Stock Solution per gallon of water.

Dairy Calves, Dairy Heifers, and Beef Cattle

Treatment Period: 5 consecutive days
 Dosage: Initial dose of 25 mg/lb followed by four maintenance doses of 12.5 mg/lb/day

Summer Administration

Dosage recommendations for summer are based on an estimated water intake of 1 gallon of water per every 100 lb of body weight per day.

Sulfadimethoxine Concentrated Solution 12.5%

Daily Drinking Water Supply

Initial Dose

Maintenance Dose

    25 gal

  1 pt (16 fl oz)

  1 cup (8 fl oz)

    50 gal

  1 qt (32 fl oz)

  1 pt (16 fl oz)

    200 gal

  1 gal (128 fl oz)

  2 qt (64 fl oz)

Winter Administration

Dosage recommendations for winter are based on an estimated water intake of 1 gallon of water per every 150 lb of body weight per day.

Sulfadimethoxine Concentrated Solution 12.5%

Daily Drinking Water Supply

Initial Dose

Maintenance Dose

    16 gal

  1 pt (16 fl oz)

  1 cup (8 fl oz)

    33 gal

  1 qt (32 fl oz)

  1 pt (16 fl oz)

    127 gal

  1 gal (128 fl oz)

  2 qt (64 fl oz)

For individual treatment of cattle, Sulfadimethoxine Concentrated Solution 12.5% may be given as a drench. Administer using an initial dose of 25 mg/lb followed by 4 maintenance doses of 12.5 mg/lb/day. One fl oz will medicate one 150-lb animal initially and 1/2 fl oz will medicate one 150-lb animal on maintenance dose.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sulfadimethoxine-jug.jpg

SULFADIMETHOXINE CONCENTRATED SOLUTION 12.5% 
sulfadimethoxine concentrated solution 12.5% solution
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:46066-081
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sulfadimethoxine (UNII: 30CPC5LDEX) (SULFADIMETHOXINE - UNII:30CPC5LDEX) Sulfadimethoxine125 mg  in 1 mL
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46066-081-113785 mL in 1 JUG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20016512/12/2022
Labeler - Aspen Veterinary Resources Ltd (627265361)

Revised: 12/2022
Document Id: 2dafa601-67e5-45bd-85bd-1b49c5c0c40c
Set id: 166380c3-20e9-43b6-addf-80fc9ccb2ab0
Version: 1
Effective Time: 20221209
 
Aspen Veterinary Resources Ltd