Lincomix 50

Manufacturer
Zoetis Inc.
Effective date
2022-12-08
Label type
VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 02:41:44

Label at a glance#

ProductLincomix 50
Active ingredientLINCOMYCIN HYDROCHLORIDE
Label structure5 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Type A Medicated Article

50 grams/lb

Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

 

For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin in broilers.

For the treatment and control of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) casued by Lawsonia  intracellularis.

For reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae.

Each pound contains:

Active Drug Ingredient

                   Lincomycin………………………………..50 grams

                   (as lincomycin hydrochloride agricultural grade)

                Inactive Ingredients  

                   Soybean hulls, #20 grind; light liquid paraffin, Ph.Eur.

 

IMPORTANT:

Must be thoroughly mixed in feeds before use.

Store opened bag in dry place to prevent caking.

 Store at room temperature.

 

Approved by FDA under NADA # 097-505

BROILERS

SPL UNCLASSIFIED SECTION

BROILERS

For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin in broilers.

DIRECTIONS FOR USE

For the control of necrotic enteritis:

LINCOMIX 50, 50 grams/lb, should be mixed into the complete feed supplied to broiler chickens so that the final feed contains 2 grams of lincomycin per ton of feed.

MIXING DIRECTIONS

Type C Medicated Feeds

Intermediate Premix

Amount of LINCOMIX 50 per 1000 lb

(454 kg) of Feed Ingredients
 

Complete Feed

Amount of Intermediate Premix to Provide 2 Grams

of lincomycin per ton of Type C Medicated Feed

lincomycin per ton of feed

2 grams

 20 lbs

4 lbs

2 lbs

 2 lbs

10 lbs

20 lbs

  

WARNING: When using LINCOMIX 50 in approved combinations with other drugs, follow the required withdrawal times for those drugs. No drug withdrawal period is required before slaughter of birds fed LINCOMIX 50 at the approved concentration (2 grams lincomycin per ton of feed).

CAUTION: Not for use in layers, breeders, or turkeys. (For additional Cautions, see below.)


SWINE

SPL UNCLASSIFIED SECTION

SWINE

For the treatment and control of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis. For reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae.

DIRECTIONS FOR USE

For the treatment of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis:

Feed 100 grams of lincomycin per ton of complete feed as the sole ration for three weeks, or until signs of disease (watery, mucoid or bloody stools) disappear.

For the treatment and control of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis:

Feed 100 grams of lincomycin per ton of complete feed as the sole ration for three weeks, or until signs of disease (watery, mucoid or bloody stools) disappear, followed by 40 grams of lincomycin per ton.

For the control of swine dysentery and porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis: Feed 40 grams of lincomycin per ton of complete feed as the sole ration. For use in animals or on premises with a history of swine dysentery, but where symptoms have not yet occurred.

For reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae :

Feed 100-200 grams of lincomycin per ton of complete feed as the sole ration for 21 days.

MIXING DIRECTIONS

Type C Medicated Feeds

For treatment of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis:

To make complete feed containing 100 grams of lincomycin, add 2 lbs of LINCOMIX 50 per ton.

For control of swine dysentery and porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis:

To make complete feed containing 40 grams of lincomycin, add 0.8 lbs of LINCOMIX 50 per ton.

For reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae:

To make complete feed containing 100- 200 grams of lincomycin, add 2-4 lbs of LINCOMIX 50 per ton.

Additional mixing directions to make complete feed containing 40, 100 or 200 grams of lincomycin per ton are provided below.

MIXING DIRECTIONS

 

IntermediatePremix

Amount of LINCOMIX 50 per 1000 lb

(454 kg) of Feed Ingredients

Complete Feed

Amount of Intermediate Premix to Provide Desired Grams of lincomycin per ton of Type C Medicated Feed

lincomycin per ton of feed

 

50 lbs

40 lbs

20 lbs

 

40 grams              100 grams            200 grams

   16 lbs                     40 lbs                      80 lbs

   20 lbs                     50 lbs                     100 lbs

   40 lbs                     100 lbs                   200 lbs


WARNING: When using LINCOMIX 50 in approved combinations with other drugs, follow the required withdrawal times for those drugs. No drug withdrawal period is required before slaughter of swine fed LINCOMIX 50 at approved concentrations (40, 100 or 100-200 grams lincomycin per ton of feed).

NOT FOR HUMAN USE

CAUTION: Occasionally, swine fed lincomycin may within the first two days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within five to eight days without discontinuing the lincomycin treatment. The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined.


SPL UNCLASSIFIED SECTION

Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.

Good Manufacturing Practices Should Be Observed in Preparing Feeds Containing LINCOMIX 50.

This Includes Appropriate Clean-out Procedures to Avoid Cross-Contamination.

Restricted Drug (California) – Use Only as Directed

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

501918

40027871

Made in China

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lincomix 50 bag label
Lincomix 50 bag label

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
54771-1494-2Lincomix 5022.7 kg in 1 BAGGRANULE22.79

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54771-1494LINCOMIX 50 (LINCOMYCIN HYDROCHLORIDE) GRANULE [ZOETIS INC.]91 package rows20221209_c402bfe3-9ceb-4a47-9bfe-55ffd84fc743.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
54771-149454771-1494-2

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
LINCOMYCIN HYDROCHLORIDEM6T05Z2B68ACTIM

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.