GEN-GARD

Manufacturer
Huvepharma, Inc | Huvepharma EOOD
Effective date
2024-06-04
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:43:24

Label at a glance#

ProductGEN-GARD Soluble Powder
Active ingredientGENTAMICIN SULFATE
Label structure19 sections

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.             E...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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

GENERAL PRECAUTIONS SECTION

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 SECTION

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 SECTION

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 SECTION

NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN

RESIDUE WARNING SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

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.

Water ConsumptionWater Consumption

ADVERSE REACTIONS SECTION

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 www.fda.gov/reportanimalae.

CONTRAINDICATIONS SECTION

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

STORAGE AND HANDLING SECTION

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     

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GenGard JarGenGard Jar

Insert_Page 1Insert_Page 1

Insert_Page 2Insert_Page 2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GENTAMICIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3b7b3a7a-635f-32a3-0c6c-7ad028e3de91Product name220250107
43025f0d-698c-68da-cec9-ea4261a7ef7aProduct name220250107
d3946667-8212-d1f2-67e1-5643a329bb56Product name220200403
4ce5dce5-e8a7-e4f6-0059-b527e4307477Product name220190501
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23243-4740-3GEN-GARDSoluble Powder360 g in 1 JARPOWDER, FOR SOLUTION3604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23243-4740GEN-GARD SOLUBLE POWDER (GENTAMICIN SULFATE) POWDER, FOR SOLUTION [HUVEPHARMA, INC]41 package rows20240730_bd4fe190-eec0-4e6e-a267-babf1934f845.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
23243-474023243-4740-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
GENTAMICIN SULFATE8X7386QRLVACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gentamicin SulfateGENTAMICIN SULFATEHospira, Inc.977180b3-a222-4282-d485-4a32176743052026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATECardinal Health 107, LLC5113bfad-42ca-4bb8-9343-0b08c6cd03f02026-05-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATEPreferred Pharmaceuticals Inc.5ac8ea7a-ee89-49f5-8d30-6dbb56503d942026-05-05Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
GentamicinGENTAMICIN SULFATEHenry Schein, Inc84f6eb1c-a287-489a-8c3e-aa5954cf19922025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATEHenry Schein, Inc.913a36c3-50d6-429a-a8dd-a03126d2ca082025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATEMedical Purchasing Solutions, LLC3532bb39-a1a6-9d67-e063-6294a90abc0c2025-05-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATEProficient Rx LP5193ed8d-44c9-46fe-924d-93aaea922cfd2025-05-01Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals,Inc.0bef2a01-69d0-cf50-e063-6294a90a4c522025-02-03Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
GentamicinGENTAMICIN SULFATEFresenius Kabi USA, LLC84f5c763-1cd3-4d85-9afb-934db8666fbf2024-10-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals, Inc.4add8f7b-48f0-6b6a-e054-00144ff88e882024-08-14Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATEBausch & Lomb Incorporated41d01350-5c4b-42fc-be5f-986ceec02bd32024-07-22Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals,Inc.82595309-304e-a221-e053-2991aa0ac0a92024-06-14Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
GENTAMICIN SULFATEGENTAMICIN SULFATENuCare Pharmaceuticals,Inc.85424b40-5c2d-421d-e053-2991aa0a77712024-06-14Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
GENTAMICIN SULFATEGENTAMICIN SULFATEHF Acquisition Co LLC, DBA HealthFirste9fbe619-2afe-f1d7-e053-2a95a90aab292024-01-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATEPadagis Israel Pharmaceuticals Ltda9486ae1-350b-41c5-ae0c-a4d692bb2dfd2024-01-15Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
gentamicin sulfateGENTAMICIN SULFATEDIRECT RX51a411a0-2671-4c1c-bf25-e29b32efed0c2024-01-10Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATESandoz Inca213fb9c-08ea-4f30-a6c9-93c7a9ba52802024-01-02Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATECosette Pharmaceuticals, Inc.16474069-510b-0754-9d78-9bc0354f65492023-11-23Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATECosette Pharmaceuticals, Inc.9e550dc9-509e-da05-8a97-ecbd0f5dd6332023-11-22Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
GentamicinGENTAMICIN SULFATEMedical Purchasing Solutions, LLC09cf88af-59da-f147-e063-6294a90aac992023-11-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.