Animal NDC 23243-4740-3 Gen-gard Soluble Powder

Gentamicin Sulfate

Animal Product Information

Field Name Field Value
Animal NDC Code 23243-4740-3
Proprietary Name Gen-gard Soluble Powder What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Gentamicin Sulfate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Huvepharma, Inc
Product Type Prescription Animal Drug
Usage Information
    For use in swine drinking water only.INDICATIONS: GEN-GARD Soluble Powder is recommended for the control and treatment of colibacillosis in weanlingswine caused by strains of E. coli sensitive to gentamicin, and for the control and treatment of swine dysenteryassociated with Brachyspira hyodysenteriae. INDICATIONS: GEN-GARD Soluble Powder is recommended for the control and treatmentof colibacillosis in weanling swine caused by strains of E. coli sensitive to gentamicinand for the control and treatment of swine dysentery associated with Brachyspirahyodysenteriae.
Active Ingredient(s)
  • Gentamicin Sulfate
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANADA200185 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Gen-gard Soluble Powder Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



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

Contains 120 grams of
Gentamicin per jar

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

GEN-GARD®
(gentamicin sulfate)
Soluble Powder
Antibacterial

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         Rev. 04-2022


General Precautions



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

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

For Swine Drinking Water Only.


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.

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.).

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.


User Safety Warnings



NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN

G-7473-03         Rev. 04-2022


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.

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.


Storage And Handling



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

Read package insert directions carefully.
Store between 2° and 30°C (36° and 86°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

Lot No.             Exp. Date

STORAGE CONDITIONS: Store between 2° and 30°C (36° and 86°F)


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.


Package Label.Principal Display Panel




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