Animal NDC 57561-474-03 Gen-gard

Gentamicin Sulfate

Animal NDC Product Code 57561-474-03

Field Name Field Value
Animal NDC Code 57561-474-03
Proprietary Name Gen-gard 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 Agri Laboratories, Ltd.
Product Type Prescription Animal Drug
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 Animal Product Label Images

Gen-gard 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.

Product Labeling Index

Indications & Usage

Gentamicin Sulfate Soluble PowderANTIBACTERIALCAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.For Swine Drinking Water Only.Contains 120 grams of Gentamicin per jarANADA 200-185, Approved by FDAINDICATIONSGEN-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 withTreponema hyodysenteriae.

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.).

Each G 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 accompanying directions carefully. Store between 2o and 30oC (36o and 86oF). For use in swine drinking water only. Restricted drug (California).Use only as directed.

Description

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

Residue Warning

For use in swine drinking water only. Swine treated with the recommeded dose of GEN-GARD Soluble Powder must not be slaughtered for food for at least ten (10) days following the last treatment.

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 gentamincin and for the control and treatment of swine dysentery associated with Treponema hyodysenteriae.

Dosage And Administration

GEN-GARD Soluble Powder is available in an 18 gram packet and 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 pkt. or 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 pkt. or 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.

Directions For Use

To prepare medicated water, mix GEN-GARD Soluble Powder and drinking water according to the following tables:Proportioner UseFor Control and Treatment of ColibacillosisAdd 18 g (1 packet or 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 DysenteryAdd 18 g (1 packet or 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 PreparationFor Control and Treatment of ColibacillosisAdd 18 g (1 packet or 1 scoop) GEN-GARD to 240 gallons of water.For Control and Treatment of Swine DysenteryAdd 18 g (1 packet or 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 temperatures, humidity, and diet.

Side Effects

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

Contraindications

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

Precautions

Store between 2o and 30oC (36o and 86oF)

How Supplied

GEN-GARD Soluble Powder is available in an 18 gram packet with 25 packets per pail, and in a 360 gram jar with 2 jars per shipper.

* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.