Lincomycin Hydrochloride Soluble Powder - Huvepharma, Inc.

Manufacturer
Huvepharma, Inc.
Effective date
2026-09-24
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
11
Source
daily-update
Hydrated at
2026-09-29 01:01:45

Label at a glance#

ProductLincomycin Hydrochloride Soluble Powder
Active ingredientLINCOMYCIN HYDROCHLORIDE
Label structure30 sections

Storage and handling

Store between 20ºC - 25ºC (68ºF - 77ºF) with excursions permitted between 15ºC - 40ºC (59ºF - 104ºF). NET WT. 2.82 OZ (80 GRAMS) Manufactured for:                          Restricted Drug – Use Only as Directed (California) Huvepharma, Inc.                         Approved by FDA under ANADA # 200-189 525 Westpark Drive, Suite 230 Peachtree City, GA 30269

Label contents#

Full prescribing information#

80 Gram Front Panel

SPL UNCLASSIFIED SECTION

Lincomycin Hydrochloride Soluble Powder
Antibacterial

GENERAL PRECAUTIONS SECTION

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

SPL UNCLASSIFIED SECTION

FOR ORAL USE IN SWINE AND BROILER CHICKENS ONLY
Not for use in laying hens, breeder chickens, pregnant swine, or swine intended for breeding.

This packet contains as active ingredient:
Lincomycin hydrochloride
         equivalent to lincomycin............................................................32 grams
See back for instructions.

RESIDUE WARNING SECTION

WITHDRAWAL PERIODS AND RESIDUE WARNINGS:
Swine and Chickens: No withdrawal period is required when used according to labeling. Not for use in chickens producing eggs for human consumption.

USER SAFETY WARNINGS SECTION

USER SAFETY WARNINGS
Not for use in humans. Keep out of reach of children.

ADVERSE REACTIONS SECTION

Contact Information: For technical assistance, to report suspected adverse drug experiences, or to obtain a Safety Data Sheet(s), contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae

STORAGE AND HANDLING SECTION

Store between 20ºC - 25ºC (68ºF - 77ºF) with excursions permitted between 15ºC - 40ºC (59ºF - 104ºF).

Take TimeTake Time

NET WT. 2.82 OZ
(80 GRAMS)

Manufactured for:                         Restricted Drug – Use Only as Directed (California)
Huvepharma, Inc.                         Approved by FDA under ANADA # 200-189
525 Westpark Drive, Suite 230
Peachtree City, GA 30269

VETERINARY INDICATIONS SECTION

SWINE: Directions for Use
INDICATIONS FOR USE: For the treatment of swine dysentery (bloody scours) in swine. Not for use in pregnant swine or swine intended for breeding.
DOSAGE AND ADMINISTRATION
DOSAGE: Administer at a dose rate of 250 mg of lincomycin per gallon of drinking water. In clinical studies, this dose rate provided an average of 3.8 mg of lincomycin per pound of body weight per day.
TREATMENT PERIOD: The drug should be administered for a minimum of 5 consecutive days beyond the disappearance of symptoms (bloody stools) up to a maximum of 10 consecutive days. If water treatment is discontinued prior to this time, a lincomycin treatment program may be continued with lincomycin premix at 100 grams lincomycin per ton of complete feed as the sole ration according to label directions.
ADMINISTRATION: This packet will medicate 128 gallons of drinking water providing 250 mg/gallon. A dose of 3.8 mg lincomycin per pound of body weight may be maintained by medicating the drinking water at a concentration of 250 mg per gallon of drinking water when pigs are consuming 1.5 gallons per 100 lbs of body weight per day. Under these circumstances the concentration of lincomycin required in medicated water may be adjusted to compensate for variations in age and weight of animals, the nature and severity of disease symptoms, environmental temperature and humidity, each of which affects water consumption. For use in automatic water proportioners, prepare the stock solution by dissolving 1 packet in 1 gallon of water; then adjust the proportioner to deliver 1 oz of stock solution per gallon of drinking water.
NOTE: After a treatment program is discontinued, a control program for swine dysentery may be followed by feeding lincomycin premix at 40 grams lincomycin per ton of complete feed as the sole ration.

BROILER CHICKENS: Directions for Use
INDICATIONS FOR USE: For the control of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin in broiler chickens.
DOSAGE AND ADMINISTRATION
DOSAGE: Administer at a dose rate of 64 mg of lincomycin per gallon of drinking water.
TREATMENT PERIOD: Start medication as soon as the diagnosis of necrotic enteritis is determined. The drug should be administered for 7 consecutive days.
ADMINISTRATION: This packet will medicate 500 gallons of drinking water providing 64 mg/gallon.
NOTE: After water medication is discontinued, a control program for necrotic enteritis may be followed by feeding lincomycin premix at 2 grams lincomycin per ton of complete feed.

PRECAUTIONS SECTION

ANIMAL SAFETY WARNINGS AND PRECAUTIONS
Discard medicated drinking water if not used within 2 days. Fresh stock solution should be prepared daily. Do not use the water treatment and the feed treatment simultaneously. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to water containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.
Swine: If clinical signs of bloody scours (watery, mucoid or bloody stools) have not improved during the first 6 days of medication, discontinue treatment and redetermine the diagnosis. Occasionally, swine fed lincomycin may within the first 2 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 safety of lincomycin has not been demonstrated for pregnant swine or swine intended for breeding.
Broiler Chickens: Not for use in laying hens or breeder chickens.

160 g front panel

SPL UNCLASSIFIED SECTION

Lincomycin Hydrochloride Soluble Powder
Antibacterial

GENERAL PRECAUTIONS SECTION

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

SPL UNCLASSIFIED SECTION

FOR ORAL USE IN SWINE AND BROILER CHICKENS ONLY
Not for use in laying hens, breeder chickens, pregnant swine, or swine intended for breeding.

This packet contains as active ingredient:
Lincomycin hydrochloride
      equivalent to lincomycin..............................................................................64 grams
See back for instructions.

RESIDUE WARNING SECTION

WITHDRAWAL PERIODS AND RESIDUE WARNINGS:
Swine and Chickens: No withdrawal period is required when used according to labeling. Not for use in chickens producing eggs for human consumption.

USER SAFETY WARNINGS SECTION

USER SAFETY WARNINGS
Not for use in humans. Keep out of reach of children.

ADVERSE REACTIONS SECTION

Contact Information: For technical assistance, to report suspected adverse drug experiences, or to obtain a Safety Data Sheet(s), contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae

SPL UNCLASSIFIED SECTION

Store between 20ºC - 25ºC (68ºF - 77ºF) with excursions permitted between 15ºC - 40ºC (59ºF - 104ºF).

Take TimeTake Time

NET WT. 5.64 OZ
(160 GRAMS)

Manufactured for:                      Restricted Drug – Use Only as Directed (California)
Huvepharma, Inc.                      Approved by FDA under ANADA # 200-189
525 Westpark Drive, Suite 230
Peachtree City, GA 30269

VETERINARY INDICATIONS SECTION

SWINE: Directions for Use
INDICATIONS FOR USE: For the treatment of swine dysentery (bloody scours) in swine. Not for use in pregnant swine or swine intended for
breeding.
DOSAGE AND ADMINISTRATION
DOSAGE: Administer at a dose rate of 250 mg of lincomycin per gallon of drinking water. In clinical studies, this dose rate provided an average
of 3.8 mg of lincomycin per pound of body weight per day.
TREATMENT PERIOD: The drug should be administered for a minimum of 5 consecutive days beyond the disappearance of symptoms (bloody stools) up to a maximum of 10 consecutive days. If water treatment is discontinued prior to this time, a lincomycin treatment program may be continued with lincomycin premix at 100 grams lincomycin per ton of complete feed as the sole ration according to label directions.
ADMINISTRATION: This packet will medicate 256 gallons of drinking water providing 250 mg/gallon. A dose of 3.8 mg lincomycin per pound of
body weight may be maintained by medicating the drinking water at a concentration of 250 mg per gallon of drinking water when pigs are consuming 1.5 gallons per 100 lbs of body weight per day. Under these circumstances the concentration of lincomycin required in medicated water may be adjusted to compensate for variations in age and weight of animals, the nature and severity of disease symptoms, environmental temperature and humidity, each of which affects water consumption. For use in automatic water proportioners, prepare the stock solution by dissolving 1 packet in 2 gallons of water; then adjust the proportioner to deliver 1 oz of stock solution per gallon of drinking water.
NOTE: After a treatment program is discontinued, a control program for swine dysentery may be followed by feeding lincomycin premix at 40
grams lincomycin per ton of complete feed as the sole ration.

BROILER CHICKENS: Directions for Use
INDICATIONS FOR USE: For the control of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin in broiler chickens.
DOSAGE AND ADMINISTRATION
DOSAGE: Administer at a dose rate of 64 mg of lincomycin per gallon of drinking water.
TREATMENT PERIOD: Start medication as soon as the diagnosis of necrotic enteritis is determined. The drug should be administered for 7
consecutive days.
ADMINISTRATION: This packet will medicate 1,000 gallons of drinking water providing 64 mg/gallon.
NOTE: After water medication is discontinued, a control program for necrotic enteritis may be followed by feeding lincomycin premix at 2 grams
lincomycin per ton of complete feed.

PRECAUTIONS SECTION

ANIMAL SAFETY WARNINGS AND PRECAUTIONS
Discard medicated drinking water if not used within 2 days. Fresh stock solution should be prepared daily. Do not use the water treatment and the feed treatment simultaneously. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to water containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.
Swine: If clinical signs of bloody scours (watery, mucoid or bloody stools) have not improved during the first 6 days of medication, discontinue treatment and redetermine the diagnosis. Occasionally, swine fed lincomycin may within the first 2 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 safety of lincomycin has not been demonstrated for pregnant swine or swine intended for breeding.
Broiler Chickens: Not for use in laying hens or breeder chickens.

480 Gram Front Panel

SPL UNCLASSIFIED SECTION

Lincomycin Hydrochloride Soluble Powder
Antibacterial

GENERAL PRECAUTIONS SECTION

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

SPL UNCLASSIFIED SECTION

FOR ORAL USE IN SWINE AND BROILER CHICKENS ONLY
Not for use in laying hens, breeder chickens, pregnant swine, or swine intended for breeding.

This packet contains as active ingredient:
Lincomycin hydrochloride
      equivalent to lincomycin.....................................................................................................................192 grams
See back for instructions.

RESIDUE WARNING SECTION

WITHDRAWAL PERIODS AND RESIDUE WARNINGS:
Swine and Chickens: No withdrawal period is required when used according to labeling. Not for use in chickens producing eggs for human consumption.

USER SAFETY WARNINGS SECTION

USER SAFETY WARNINGS
Not for use in humans. Keep out of reach of children.

ADVERSE REACTIONS SECTION

Contact Information: For technical assistance, to report suspected adverse drug experiences, or to obtain a Safety Data Sheet(s), contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae

SPL UNCLASSIFIED SECTION

Store between 20˚C - 25˚C (68˚F - 77˚F) with excursions permitted between 15˚C - 40˚C (59˚F - 104˚F).

Take TimeTake Time

NET WT. 16.92 OZ
(480 grams)

Manufactured for:                      Restricted Drug – Use Only as Directed (California)
Huvepharma, Inc.                      Approved by FDA under ANADA # 200-189
525 Westpark Drive, Suite 230
Peachtree City, GA 30269

VETERINARY INDICATIONS SECTION

SWINE: Directions for Use
INDICATIONS FOR USE: For the treatment of swine dysentery (bloody scours) in swine. Not for use in pregnant swine or swine intended for breeding.
DOSAGE AND ADMINISTRATION
DOSAGE: Administer at a dose rate of 250 mg of lincomycin per gallon of drinking water. In clinical studies, this dose rate provided an average of 3.8 mg of lincomycin per pound of body weight per day.
TREATMENT PERIOD: The drug should be administered for a minimum of 5 consecutive days beyond the disappearance of symptoms (bloody stools) up to a maximum of 10 consecutive days. If water treatment is discontinued prior to this time, a lincomycin treatment program may be continued with lincomycin premix at 100 grams lincomycin per ton of complete feed as the sole ration according to label directions.
ADMINISTRATION: This packet will medicate 768 gallons of drinking water providing 250 mg/gallon. A dose of 3.8 mg lincomycin per pound of body weight may be maintained by medicating the drinking water at a concentration of 250 mg per gallon of drinking water when pigs are consuming 1.5 gallons per 100 lbs of body weight per day. Under these circumstances the concentration of lincomycin required in medicated water may be adjusted to compensate for variations in age and weight of animals, the nature and severity of disease symptoms, environmental temperature and humidity, each of which affects water consumption. For use in automatic water proportioners, prepare the stock solution by dissolving 1 packet in 6 gallons of water; then adjust the proportioner to deliver 1 oz of stock solution per gallon of drinking water.
NOTE: After a treatment program is discontinued, a control program for swine dysentery may be followed by feeding lincomycin premix at 40 grams lincomycin per ton of complete feed as the sole ration.

BROILER CHICKENS: Directions for Use
INDICATIONS FOR USE: For the control of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin in broiler chickens.
DOSAGE AND ADMINISTRATION
DOSAGE: Administer at a dose rate of 64 mg of lincomycin per gallon of drinking water.
TREATMENT PERIOD: Start medication as soon as the diagnosis of necrotic enteritis is determined. The drug should be administered for 7 consecutive days.
ADMINISTRATION: This packet will medicate 3,000 gallons of drinking water providing 64 mg/gallon.
NOTE: After water medication is discontinued, a control program for necrotic enteritis may be followed by feeding lincomycin premix at 2 grams lincomycin per ton of complete feed.

PRECAUTIONS SECTION

ANIMAL SAFETY WARNINGS AND PRECAUTIONS
Discard medicated drinking water if not used within 2 days. Fresh stock solution should be prepared daily. Do not use the water treatment and the feed treatment simultaneously. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to water containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.
Swine: If clinical signs of bloody scours (watery, mucoid or bloody stools) have not improved during the first 6 days of medication, discontinue treatment and redetermine the diagnosis. Occasionally, swine fed lincomycin may within the first 2 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 safety of lincomycin has not been demonstrated for pregnant swine or swine intended for breeding.
Broiler Chickens: Not for use in laying hens or breeder chickens.

80 g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80 g80 g

160 g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

160 g160 g

480 g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

480 g480 g

DailyMed Product Concepts#

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

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
23243-675223243-6752-7, 23243-6752-8, 23243-6752-9

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 · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102024-12-14full-release2026-06-01 02:44:01

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.