DI-METHOX CONCENTRATED SOLUTION 12.5%- sulfadimethoxine concentrated solution 12.5% solution, concentrate

Di-Methox Concentrated Solution 12.5% by

Drug Labeling and Warnings

Di-Methox Concentrated Solution 12.5% by is a Animal medication manufactured, distributed, or labeled by Huvepharma, Inc, Huvepharma EOOD, Sparhawk Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

      NDC: 23243-370-07

         DI-METHOX®
      (sulfadimethoxine)
CONCENTRATED SOLUTION 12.5%

WARNINGS AND PRECAUTIONS

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

SPL UNCLASSIFIED SECTION

Antibacterial for use in drinking water

For Oral Use in Chickens, Turkeys and Cattle

3.75 g sulfadimethoxine/fl oz

Protect From Light

Approved by FDA under ANADA # 200-030

NET CONTENTS: 3.8 Liters (1 GALLON)

VETERINARY INDICATIONS

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

PRECAUTIONS

PRECAUTION: Store at room temperature; 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.

RESIDUE WARNING

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.

STORAGE AND HANDLING

STORE AT CONTROLLED ROOM TEMPERATURE 20–25°C (68–77°F).

USER SAFETY WARNINGS

NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN
Restricted Drug (California) – Use Only as Directed

To report suspected adverse drug events, for technical assistance or to obtain a copy
of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883 or
www.huvepharma.us. For additional information about adverse drug experience
reporting for animal drugs, contact FDA at 1-888-FDA-VETS or
http://www.fda.gov/reportanimalae.

SPL UNCLASSIFIED SECTION

S-3369-07
Rev. 03-2021

Manufactured for
Huvepharma, Inc.
Peachtree City, GA 30269          ® Registered trademark of Huvepharma, Inc.

LOT NO.:                                     EXP. DATE:

DOSAGE & ADMINISTRATION

Dosage and Administration
Chickens and Turkeys
Treatment Period: 6 consecutive days
Recommended Concentration: Chickens–0.05%; Turkeys–0.025%
Chickens	Add 1 fl oz (30 mL) to 2 gal of drinking water or 25 fl oz to 50 gal of drinking water.
Turkeys	Add 1 fl oz (30 mL) to 4 gal of drinking water or 25 fl oz to 100 gal of drinking water.
Automatic Proportioners*Stock Solution–To make 2 gal of stock solution:
Chickens	Add 1 gal of DiMethox® Concentrated Solution 12.5% to 1 gal of water.
Turkeys	Add 2 qt of DiMethox® Concentrated Solution 12.5% to 6 qt of water.

*Set proportioner to a feed rate of 1 fl oz of stock solution per gal 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 gal
   of water for every 100 lb of body weight per day.

DiMethox® 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 gal
   of water for every 150 lb of body weight per day.

DiMethox® 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, Di-Methox® 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DI-METHOX CONCENTRATED SOLUTION 12.5% 
sulfadimethoxine concentrated solution 12.5% solution, concentrate

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 23243-3700
Route of Administration	Oral

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sulfadimethoxine (UNII: 30CPC5LDEX) (SULFADIMETHOXINE - UNII:30CPC5LDEX)	Sulfadimethoxine	3750 mg  in 0.2366 L

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23243-3700-7	3.8 L in 1 JUG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200030	02/01/2009

Labeler - Huvepharma, Inc (619153559)

Registrant - Huvepharma EOOD (552671651)

Establishment
Name	Address	ID/FEI	Business Operations
Sparhawk Laboratories, Inc.		147979082	manufacture, analysis