GEN-GARD SOLUBLE POWDER- gentamicin sulfate powder, for solution

GEN-GARD by

Drug Labeling and Warnings

GEN-GARD by is a Animal medication manufactured, distributed, or labeled by Huvepharma, Inc, Huvepharma EOOD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

NDC: 23243-4740-3
GEN-GARD®
(gentamicin sulfate)
Soluble Powder
Antibacterial

GENERAL PRECAUTIONS

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

SPL UNCLASSIFIED SECTION

Contains 120 grams of
Gentamicin per jar

Approved by FDA under ANADA # 200-185
NET WEIGHT:
360 g (12.7 oz.)

INDICATIONS & USAGE

For use in swine drinking water only.
INDICATIONS: GEN-GARD Soluble Powder is recommended for the control and treatment of colibacillosis in weanling
swine caused by strains of E. coli sensitive to gentamicin, and for the control and treatment of swine dysentery
associated with Brachyspira hyodysenteriae.

DOSAGE & ADMINISTRATION

DOSE: Colibacillosis - 1 level scoop per 240 gallons of drinking water for 3 consecutive days, 0.5 mg/lb/day.
For proportioner use, add 1 level scoop to 2 gallons stock solution and dispense at the rate of 1 oz./gal. drinking
water (25 mg/gal.).
Swine Dysentery - 1 level scoop per 120 gallons of drinking water for 3 consecutive days, 1.0 mg/lb/day.
For proportioner use, add 1 level scoop to 1 gallon stock solution and dispense at the rate of 1 oz./gal. drinking
water (50 mg/gal.).

USER SAFETY WARNINGS

NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN

RESIDUE WARNING

Each gram contains: gentamicin sulfate equivalent to
333.33 mg gentamicin base.

RESIDUE WARNING: Swine treated with the recommended dose of GEN-GARD
Soluble Powder must not be slaughtered for food for at least ten (10) days following
the last treatment.

STORAGE AND HANDLING

Do not store or offer medicated water in rusty metal containers.

Read package insert directions carefully.
Store between 2° and 25°C (36° and 77°F).
Excursions permitted to 40°C (104°F).
For use in swine drinking water only.
Restricted drug (California)-
Use only as directed.

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

Lot No.             Exp. Date

SPL UNCLASSIFIED SECTION

GEN-GARD®
(gentamicin sulfate)
Soluble Powder
Antibacterial

GENERAL PRECAUTIONS

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

For Swine Drinking Water Only.

RESIDUE WARNING

DESCRIPTION: Each gram of GEN-GARD Soluble Powder contains gentamicin sulfate
equivalent to 333.33 mg gentamicin base.

RESIDUE WARNING: Swine treated with the recommended dose of
GEN-GARD Soluble Powder must not be slaughtered for food for at least ten
(10) days following the last treatment.

INDICATIONS & USAGE

INDICATIONS: GEN-GARD Soluble Powder is recommended for the control and treatment
of colibacillosis in weanling swine caused by strains of E. coli sensitive to gentamicin
and for the control and treatment of swine dysentery associated with Brachyspira
hyodysenteriae.

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION: GEN-GARD Soluble Powder is available in a 360 gram
jar. The 360 gram jar contains a scoop that provides approximately 18 grams of product
when level full.

For Control and Treatment of Colibacillosis - Administer GEN-GARD Soluble Powder in
drinking water at the recommended level of 25 mg per gallon (1 scoop/240 gallons) for
three consecutive days.

For Control and Treatment of Swine Dysentery - Administer GEN-GARD Soluble Powder in
drinking water at the recommended level of 50 mg per gallon (1 scoop/120 gallons) for
three consecutive days.

The concentration of the medication should be adjusted in extremely hot or cold
weather to ensure a gentamicin dosage of approximately 0.5 mg/lb/day for 3 days for
colibacillosis or 1.0 mg/lb/day for 3 days for swine dysentery. A 50-lb pig will, under
average conditions, consume 0.9 gallon of water per day.

For swine dysentery, if the condition recurs, the medication may be repeated. Because
of the tendency for the disease to recur on a premise with a history of swine dysentery,
a control program should be used following treatment.

INSTRUCTIONS FOR USE

DIRECTIONS FOR USE: To prepare medicated water, mix GEN-GARD Soluble Powder and
drinking water according to the following tables:

Proportioner Use:
For Control and Treatment of Colibacillosis
   Add 18 g (1 scoop) GEN-GARD to 2 gallons of water to make stock solution and
   dispense at the rate of one ounce per gallon of drinking water. This will result in
   drinking water that contains 25 mg/gallon.

For Control and Treatment of Swine Dysentery
   Add 18 g (1 scoop) GEN-GARD to 1 gallon of water to make stock solution and
   dispense at the rate of one ounce per gallon of drinking water. This will result in
   drinking water that contains 50 mg/gallon.

Bulk Preparation:
For Control and Treatment of Colibacillosis
   Add 18 g (1 scoop) GEN-GARD to 240 gallons of water.

For Control and Treatment of Swine Dysentery
   Add 18 g (1 scoop) GEN-GARD to 120 gallons of water.

Medicated drinking water should not be stored or offered in rusty containers since the
drug is quickly destroyed in such containers.

Medicated water should be prepared daily and be the sole source of drinking water for
3 consecutive days.

The daily water consumption figures shown below are approximations for mild
temperatures and are presented as a guide only. Actual water consumption varies with
environmental temperature, humidity, and diet.

ADVERSE REACTIONS

SIDE EFFECTS: There have been no reported side effects following the recommended use
of GEN-GARD Soluble Powder in swine.

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.

CONTRAINDICATIONS

CONTRAINDICATIONS: There are no known contraindications to this drug when used
as directed.

STORAGE AND HANDLING

STORAGE CONDITIONS: Store between 2° and 25°C (36° and 77°F). Excursions permitted
to 40°C (104°F).

SPL UNCLASSIFIED SECTION

HOW SUPPLIED: GEN-GARD Soluble Powder is available in a 360 gram jar with 2 jars
per shipper.

Approved by FDA under ANADA # 200-185
Not for Use in Humans
Keep Out of Reach of Children
Restricted Drug (California) –
use only as directed

Manufactured for
Huvepharma, Inc.
Peachtree City, GA 30269
Made in Bulgaria     

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GEN-GARD  SOLUBLE POWDER
gentamicin sulfate powder, for solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 23243-4740
Route of Administration	oral

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG)	GENTAMICIN	333.33 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23243-4740-3	360 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200185	04/04/2011

Labeler - Huvepharma, Inc (619153559)

Registrant - Huvepharma EOOD (552671651)