Gentamicin Piglet Injection (GENTAMICIN SULFATE, USP) Piglet Injection - 5 mg/mL

Manufacturer
Sparhawk Laboratories, Inc.
Effective date
2013-06-10
Label type
OTC ANIMAL DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:39:36

Label at a glance#

ProductGENTAMICIN PIGLET
Active ingredientGENTAMICIN SULFATE
Label structure11 sections

Dosage and administration

The recommended dose is 1 mL (5 mg) administered intramuscularly. Gentamicin Piglet Injection is not to be used more than once in each piglet. If piglets do not respond to treatment with Gentamicin Piglet Injection, diagnosis should be reevaluated. Clean and sterilize needles and syringes by boiling in water for 15 minutes prior to use. Prior to injection, disinfect the injection site and top the vial with a suita...

Storage and handling

Store between 2 o and 30 o C (36 o and 86 o F) Protect from freezing. For intramuscular use only. TAKE TIME OBSERVE LABEL DIRECTIONS

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Piglet Injection Veterinary

Antibacterial

For Piglets Up to 3 days of age

For intramuscular use only.

ANADA#: 200-394 Approved by F.D.A

DESCRIPTION

DESCRIPTION SECTION

Gentamicin Piglet Injection is a sterile preparation for intramuscular administration in piglets up to 3 days of age. Each milliliter contains gentamicin sulfate, USP equivalent to 5 mg gentamicin base, 2 mg sodium bisulfite, 0.1 mg edetate disodium, 7.46 mg sodium acetate, 3 mg glacial acetic acid; 1.3 mg methylparaben and 0.2 mg propylparaben as preservatives, water for injection q.s.

WARNING

WARNINGS SECTION

For use in piglets up to 3 days of age only.

Piglets injected with Gentamicin Piglet Injection must not be slaughtered for food for at least forty (40) days following treatment. Use of more than the recommended dose will result in gentamicin tissue residues beyond forty (40) days.

Restricted Drug (California)--use only as directed.

Read accompanying directions carefully.

INDICATIONS

INDICATIONS & USAGE SECTION

Gentamicin Piglet Injection is recommended for the treatment of porcine colibacillosis caused by strains of E. coli sensitive to gentamicin.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

The recommended dose is 1 mL (5 mg) administered intramuscularly. Gentamicin Piglet Injection is not to be used more than once in each piglet. If piglets do not respond to treatment with Gentamicin Piglet Injection, diagnosis should be reevaluated. Clean and sterilize needles and syringes by boiling in water for 15 minutes prior to use. Prior to injection, disinfect the injection site and top the vial with a suitable disinfectant, such as 70% alcohol. Use all precautions to prevent contamination of vial contents.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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

PRECAUTIONS

PRECAUTIONS SECTION

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

CHEMISTRY

COMPONENTS

Gentamicin is a mixture of aminoglycoside antibiotics derived from the fermentation of Micromonospora purpurea. Gentamicin Sulfate, USP is a mixture of sulfate salts of the antibiotics produced in the fermentation. The salts are weakly acidic and freely soluble in water. Gentamicin sulfate, USP is stable in solution for the period of time indicated on the labels by the expiration date.

Gentamicin sulfate, USP contains not less than 500 micrograms of gentamicin base per milligram.

HOW SUPPLIED

HOW SUPPLIED SECTION

Enter section text here

STORAGE AND HANDLING SECTION

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

Protect from freezing.

For intramuscular use only.

TAKE TIME OBSERVE LABEL DIRECTIONS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured by
Sparhawk Laboratories, Inc.
Lenexa, KS 66215

G-6639-04                       Rev. 2-09


Gentamicin Piglet LabelGentamicin Piglet Label

Gentamicin Piglet Onsert LabelGentamicin Piglet Onsert Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
102770gentamicin 5 MG/ML Injectable SolutionSCD3

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
58005-663-04GENTAMICIN PIGLET100 mL in 1 VIALINJECTION1003
58005-663-05GENTAMICIN PIGLET250 mL in 1 VIALINJECTION2503
58005-663-06GENTAMICIN PIGLET500 mL in 1 VIALINJECTION5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58005-663GENTAMICIN PIGLET (GENTAMICIN SULFATE) INJECTION [SPARHAWK LABORATORIES, INC.]33 package rows20130612_a9be1c83-e2c4-4b5f-a249-cb7c4e912c4a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLV3
GENTAMICINACTIVE MOIETYT6Z9V48IKG3

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
58005-66358005-663-04, 58005-663-05, 58005-663-06

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.