FDA.reportPublic FDA data

Garasol ® (gentamicin injection)

Manufacturer
Merck Sharp & Dohme Corp.
Effective date
2026-02-06
Label type
OTC ANIMAL DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:45:54

Label at a glance#

ProductGARASOL
Active ingredientGENTAMICIN SULFATE
Label structure9 sections

Dosage and administration

Chickens: Each day-old chicken should be aseptically injected subcutaneously in the neck with GARASOL Injection diluted with sterile, physiologic saline solution to provide 0.2 mg gentamicin in a 0.2-mL dose. This concentration can be provided by diluting GARASOL Injection as follows: GARASOL mL Sterile Saline mL   # Doses Dose/Chicken mL 1 99 500 0.2 2 198 1000 0.2 4 396 2000 0.2 10 990 5000 0.2 100 (1 bottle) 99...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Injection – 100 mg/mL
Anti-Infective for
Day-Old Chickens and
One- to Three-Day-Old
Turkeys

PRODUCT
INFORMATION

Approved by FDA under NADA # 101-862

SPL UNCLASSIFIED SECTION

CAUTION Federal law restricts this drug to use by or on the order of a licensed veterinarian

DESCRIPTION SECTION

DESCRIPTION Each milliliter of GARASOL Injection contains 100 mg gentamicin base (equivalent to 156 mg gentamicin sulfate); 3.2 mg sodium bisulfite; 0.1 mg edetate disodium; 4.5 mg sodium acetate, anhydrous; 3.0 mg glacial acetic acid; 0.8 mg methylparaben and 0.1 mg propylparaben as preservatives; water for injection q.s.

SPL UNCLASSIFIED SECTION

CHEMISTRY Gentamicin is a bactericidal aminoglycoside antibiotic derived from Micromonospora purpurea of the Actinomycetes group. It is a powder, readily soluble in water and basic in nature. Gentamicin aqueous solutions do not require refrigeration and are stable overa wide range of temperatures and pH.

VETERINARY INDICATIONS SECTION

INDICATIONS Day-old chickens – GARASOL Injection is recommended for the prevention of early mortality associated with Escherichia coli, Salmonella typhimurium, and Pseudomonas aeruginosa susceptible to gentamicin sulfate. Turkeys – As an aid in the prevention of early mortality of 1- to 3-day-old turkeys associated with Arizona paracolon infections susceptible to gentamicin sulfate.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

SPL UNCLASSIFIED SECTION

Chickens: Each day-old chicken should be aseptically injected subcutaneously in the neck with GARASOL Injection diluted with sterile, physiologic saline solution to provide 0.2 mg gentamicin in a 0.2-mL dose. This concentration can be provided by diluting GARASOL Injection as follows:

GARASOL
mL		Sterile Saline
mL  		# DosesDose/Chicken
mL
1995000.2
219810000.2
439620000.2
1099050000.2
100 (1 bottle)9900500000.2

SPL UNCLASSIFIED SECTION

Turkeys: Each 1- to 3-day-old turkey should be aseptically injected subcutaneously in the neck with GARASOL Injection diluted with sterile, physiologic saline solution to provide 1 mg gentamicin in a 0.2-mL dose. The dose should be injected under the loose skin on top of the neck, halfway between the head and base of the neck. This concentration can be provided by diluting GARASOL Injection as follows:

GARASOL
mL		Sterile Saline
mL  		# DosesDose/Turkey
mL
1191000.2
2382000.2
4764000.2
1019010000.2
100 (1 bottle)1900100000.2

Clean and sterilize needles and syringes by boiling in water for 15 minutes prior to use.

Disinfect the injection site and top of the bottle with a suitable disinfectant, such as 70% isopropyl alcohol.

Use all precautions to prevent contamination of vial contents.

RESIDUE WARNING SECTION

Residue Warnings For use in day-old chickens and 1- to 3-day-old turkeys only. Chickens injected with GARASOL Injection must not be slaughtered for food for at least 5 weeks following treatment. Turkeys injected with GARASOL Injection must not be slaughtered for food for at least 9 weeks following treatment.

HOW SUPPLIED SECTION

HOW SUPPLIED GARASOL Injection, 100 mg/mL, is available in 100-mL multiple-dose vials, NDC 0061-0134-01.

STORAGE AND HANDLING SECTION

Store between 2° and 30°C (36° and 86°F). Use within 28 days of first puncture and puncture a maximum of 10 times.

SPL UNCLASSIFIED SECTION

Intervet Inc. (d/b/a Merck Animal Health)
Rahway, NJ 07065

Formulated in Germany.

Rev. 12/2025

Copyright © 2025 Merck & Co., Inc., Rahway, NJ,
USA and its affiliates.
All rights reserved.

MERCK
Animal Health

244432 R1

PRINCIPAL DISPLAY PANEL - 100 mL Vial Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mg/mL

Sterile

Garasol®
(gentamicin injection)
Injection

Caution: Federal law restricts
this drug to use by or on the
order of a licensed veterinarian

(100 mL)

Approved by FDA under
NADA # 101-862

MERCK
Animal Health

PRINCIPAL DISPLAY PANEL - 100 mL Vial Label
PRINCIPAL DISPLAY PANEL - 100 mL Vial Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1667692Garasol 100 MG/ML Injectable SolutionPSN6
1485222Gentamicin 100 MG/ML Injectable SolutionPSN6
1667692gentamicin 100 MG/ML Injectable Solution [Garasol]SBD6
1485222gentamicin 100 MG/ML Injectable SolutionSCD6
1667692Garasol 100 MG/ML Injectable SolutionSY6

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
0061-0134-01GARASOL100 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1006

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLV1
gentamicinACTIVE MOIETYT6Z9V48IKG1
waterINACTIVE INGREDIENT059QF0KO0R1

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
0061-01340061-0134-01

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 · 31 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.