Lincomycin-Spectinomycin

Manufacturer
Huvepharma, Inc | Huvepharma EOOD
Effective date
2025-04-16
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:44:30

Label at a glance#

ProductLincomycin-Spectinomycin Water Soluble Powder
Active ingredientLINCOMYCIN HYDROCHLORIDE, SPECTINOMYCIN HYDROCHLORIDE
Label structure10 sections

Storage and handling

Restricted Drug (California) - Use Only as Directed Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 23243-4240-2

LINCOMYCIN-SPECTINOMYCIN

WATER SOLUBLE POWDER
Antibacterial and Antimycoplasmal

GENERAL PRECAUTIONS SECTION

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

FOR USE IN CHICKENS ONLY

DOSAGE & ADMINISTRATION SECTION

This packet contains:
Lincomycin hydrochloride, equivalent to lincomycin ...... 16.7 grams
Spectinomycin dihydrochloride pentahydrate,
                        equivalent to spectinomycin.................33.3 grams
                                     Total Antibiotic Activity             50.0 grams Approved by FDA under ANADA # 200-407
NET WEIGHT: 2.65 oz (75 grams)

Manufactured for Huvepharma, Inc.
Peachtree City, Georgia 30269
Made in Bulgaria ® Registered Trademark of Huvepharma, Inc. LOT EXP.

INDICATIONS & USAGE SECTION

                                                      DIRECTIONS FOR USE
INDICATIONS AND USAGE: For use in chickens up to 7 days of age as an aid in the control of:
Airsacculitis caused by either Mycoplasma synoviae or Mycoplasma gallisepticum susceptible to lincomycin-spectinomycin.
Complicated Chronic Respiratory Disease (Air Sac Infection) caused by Escherichia coli and M. gallisepticum susceptible
to lincomycin-spectinomycin.

DOSAGE & ADMINISTRATION SECTION

DOSAGE AND ADMINISTRATION
Dosage: Provide 2 grams (g) antibiotic activity per gallon of drinking water. Administer as the sole source of water for the first 5 to 7 days of life.

Administration:

Amount of Lincomycin-Spectinomycin Amount of Drinking Water
 1 packet 25 gallons
For proportioners delivering 1 ounce of solution per gallon of drinking water,
dissolve contents of 5 packets in each gallon of proportioner solution.

IMPORTANT: Chickens should consume water at the following approximate rate to ensure intake of the required dose of lincomycin-spectinomycin indicated:

 Broilers and Layer Replacements (Light and Heavy)
 Age
(Weeks)
 Daily Water Intake
(Gallons/1000)
 Dosage
(mg Antibiotic/lb)
 1 5 50-65

GENERAL PRECAUTIONS SECTION

PRECAUTION: Discard medicated drinking water daily and replace with fresh medicated drinking water.

USER SAFETY WARNINGS SECTION

WARNING:    Not for Use in Humans
                     Keep Out of Reach of Children

CONTACT INFORMATION:
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

STORAGE AND HANDLING SECTION

Restricted Drug (California) - Use Only as Directed
Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F)

SPL UNCLASSIFIED SECTION

Manufactured For: Huvepharma, Inc. Peachtree City, GA 30269

Made in Bulgaria

® Registered Trademark of Huvepharma, Inc.

Take TimeTake Time

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lincomycin-Spectinomycin Packets P. 1Lincomycin-Spectinomycin Packets P. 1

Lincomycin Spectinomycin Packets P. 2Lincomycin Spectinomycin Packets P. 2

Lincomycin Spectinomycin Packets P. 3Lincomycin Spectinomycin Packets P. 3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
673b6365-42b3-455d-b9d1-7358f1db4536Product name420231212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23243-4240-2Lincomycin-SpectinomycinWater Soluble Powder75 g in 1 PACKETPOWDER, FOR SOLUTION754

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23243-4240LINCOMYCIN-SPECTINOMYCIN WATER SOLUBLE POWDER (LINCOMYCIN-SPECTINOMYCIN) POWDER, FOR SOLUTION [HUVEPHARMA, INC]41 package rows20250418_3e8710f8-d1e2-45ae-ac69-a97e0a35a655.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
23243-424023243-4240-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LINCOMYCINLINCOMYCIN HYDROCHLORIDEHenry Schein, Inc.a7692968-7ac8-48ab-89a4-27c7803e31f42025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LINCOMYCIN HYDROCHLORIDE
LincocinLINCOMYCIN HYDROCHLORIDEPharmacia & Upjohn Company LLCc01906fa-2c73-4c13-9765-2fd06628d2632025-03-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LINCOMYCIN HYDROCHLORIDE
LincomycinLINCOMYCIN HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma23f9608c-3126-35db-e063-6294a90af0542024-10-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LINCOMYCIN HYDROCHLORIDE
LincomycinLINCOMYCIN HYDROCHLORIDESagent Pharmaceuticals75e149cc-b668-427e-bae7-a0d215e4fb7a2023-03-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LINCOMYCIN HYDROCHLORIDE
LincomycinLINCOMYCIN HYDROCHLORIDEXGen Pharmaceuticals DJB, Inc.61f4851d-d919-400d-912a-05eb9dca11d42022-10-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LINCOMYCIN HYDROCHLORIDE
lincomycin hydrochlorideLINCOMYCIN HYDROCHLORIDEGland Pharma Limitedc2b5be20-cc6f-4221-9d3e-3f8b5886cd052022-09-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LINCOMYCIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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