Label: LINCOMYCIN HYDROCHLORIDE powder, for solution

  • NDC Code(s): 23243-6752-1, 23243-6752-2, 23243-6752-3
  • Packager: Huvepharma, Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated April 26, 2023

If you are a consumer or patient please visit this version.

  • 80 Gram Packet Front Panel

    Lincomycin Hydrochloride Soluble Powder
    Antibacterial

  • SPL UNCLASSIFIED SECTION

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

  • STORAGE AND HANDLING

    This packet contains as an active ingredient:
    Lincomycin HCl, equivalent to 32 g lincomycin

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

    Net Weight
    80 grams
    (2.82 oz)

  • VETERINARY INDICATIONS

    For Oral Use in Swine and Broiler Chickens Only
    Not for use in layer and breeder chickens
    Keep Out of Reach of Children

    INDICATIONS AND USAGE:
    Swine: Lincomycin Hydrochloride Soluble Powder is indicated for the treatment of swine dysentery (bloody scours).
    Broiler Chickens: Lincomycin Hydrochloride Soluble Powder is indicated for the control of necrotic enteritis caused
    by Clostridium perfringens susceptible to lincomycin.

  • ADVERSE REACTIONS

    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 http://www.fda.gov/reportanimalae.

  • RESIDUE WARNING

    RESIDUE WARNINGS:

    No drug withdrawal period is required before slaughter of swine receiving Lincomycin Hydrochloride
    Soluble Powder at the approved level of 250 mg per gallon of drinking water, nor before slaughter
    of birds receiving Lincomycin Hydrochloride Soluble Powder at the approved level of 64 mg per
    gallon of drinking water.

  • SPL UNCLASSIFIED SECTION

    Take Time

    Restricted Drug (California) - Use only as directed.
    Not for Human Use.
    Approved by FDA under ANADA # 200-189
    KCP-S00054
    P08-3902BF (Rev. 03-2022)

    Huvepharma®
    Manufactured for:
    Huvepharma, Inc.
    525 Westpark Drive, Suite 230
    Peachtree City, GA 30269

  • DOSAGE & ADMINISTRATION

    SWINE: Directions for use
    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 lb 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 g 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 lb 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.

  • DOSAGE & ADMINISTRATION

    BROILER CHICKENS: Directions for use
    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

    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 5 to 8 days without discontinuing the lincomycin treatment. The safety of lincomycin has
    not been demonstrated for pregnant swine or swine intended for breeding.
    Chickens: Not for use in layer and breeder chickens.

  • 160 Gram Front Panel

    Lincomycin Hydrochloride Soluble Powder
    Antibacterial

  • GENERAL PRECAUTIONS

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

  • STORAGE AND HANDLING

    This packet contains as an active ingredient:
    Lincomycin HCl, equivalent to 64 g lincomycin

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

    Net Weight
    160 grams
    (5.64 oz)

  • INDICATIONS & USAGE

    For Oral Use in Swine and Broiler Chickens Only

    Not for use in layer or breeder chickens

    Keep Out of Reach of Children

    INDICATIONS AND USAGE:

    Swine: Lincomycin Hydrochloride Soluble Powder is indicated for the treatment of swine dysentery (bloody scours).

    Broiler Chickens: Lincomycin Hydrochloride Soluble Powder is indicated for the control of necrotic enteritis caused
    by Clostridium perfringens susceptible to lincomycin.

  • ADVERSE REACTIONS

    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 http://www.fda.gov/reportanimalae.

  • RESIDUE WARNING

    RESIDUE WARNINGS:

    No drug withdrawal period is required before slaughter of swine receiving Lincomycin Hydrochloride
    Soluble Powder at the approved level of 250 mg per gallon of drinking water, nor before slaughter
    of birds receiving Lincomycin Hydrochloride Soluble Powder at the approved level of 64 mg per
    gallon of drinking water.

  • SPL UNCLASSIFIED SECTION

    Take Time

    Take Time

    Huvepharma®
    Manufactured for:
    Huvepharma, Inc.
    525 Westpark Drive, Suite 230
    Peachtree City, GA 30269

    Restricted Drug (California) - Use only as directed.
    Not for Human Use.
    Approved by FDA under ANADA # 200-189
    KCP-S00093
    P08-3903BF (Rev. 03-2022)

  • DOSAGE & ADMINISTRATION

    SWINE: Directions for use
    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 lb 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 g 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 lb 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. 

  • DOSAGE & ADMINISTRATION

    BROILER CHICKENS: Directions for use
    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 1000 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

    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 5 to 8 days without discontinuing
    the lincomycin treatment. The safety of lincomycin has not been demonstrated for pregnant swine or
    swine intended for breeding.
    Chickens: Not for use in layer and breeder chickens.

  • 480 Gram Front Panel

    Lincomycin Hydrochloride Soluble Powder
    Antibacterial

  • PRECAUTIONS

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

  • STORAGE AND HANDLING

    This packet contains as an active ingredient:
    Lincomycin HCl, equivalent to 192 g lincomycin
    Store between 20˚C - 25˚C (68˚F - 77˚F) with excursions permitted
    between 15˚C - 40˚C (59˚F - 104˚F). See back for instructions.

    Net Weight
    480 grams
    (16.92 oz)

  • VETERINARY INDICATIONS

    For Oral Use in Swine and Broiler Chickens Only
    Not for use in layer and breeder chickens
    Keep Out of Reach of Children

    INDICATIONS AND USAGE:

    Swine: Lincomycin Hydrochloride Soluble Powder is indicated
    for the treatment of swine dysentery (bloody scours).
    Broiler Chickens: Lincomycin Hydrochloride Soluble Powder is
    indicated for the control of necrotic enteritis caused by Clostridium
    perfringens susceptible to lincomycin.

  • ADVERSE REACTIONS

    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 http://www.fda.gov/reportanimalae.

  • RESIDUE WARNING

    RESIDUE WARNINGS:

    No drug withdrawal period is required before slaughter of
    swine receiving Lincomycin Hydrochloride Soluble Powder at
    the approved level of 250 mg per gallon of drinking water, nor
    before slaughter of birds receiving Lincomycin Hydrochloride
    Soluble Powder at the approved level of 64 mg per gallon of
    drinking water.

  • SPL UNCLASSIFIED SECTION

    Take Time

    Take Time

    Huvepharma®
    Manufactured for:
    Huvepharma, Inc.
    525 Westpark Drive, Suite 230
    Peachtree City, GA 30269

    Restricted Drug (California) - Use only as directed.
    Not for Human Use.

    Approved by FDA under ANADA # 200-189
    KCP-S00097
    KLA-N00004 (Rev. 12-2022)

  • SWINE: Directions for use 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 lb 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 g 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 lb 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.

  • SPL UNCLASSIFIED SECTION

    BROILER CHICKENS: Directions for use
    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 3000 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

    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 5 to 8 days without
    discontinuing the lincomycin treatment. The safety of lincomycin has not been
    demonstrated for pregnant swine or swine intended for breeding.
    Chickens: Not for use in layer and breeder chickens.

  • 80 GRAM Packet Label Image

    80 GRAM Packet Label Image

  • 160 GRAM Packet Label Image

    160 GRAM Packet Label Image160 GRAM Packet Label Image

  • 480 GRAM Packet Label Image

    480 GRAM Packet Label Image

  • INGREDIENTS AND APPEARANCE
    LINCOMYCIN HYDROCHLORIDE 
    lincomycin hydrochloride powder, for solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:23243-6752
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F) LINCOMYCIN0.4 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23243-6752-125 in 1 PAIL
    180 g in 1 PACKET
    2NDC:23243-6752-220 in 1 PAIL
    2160 g in 1 PACKET
    3NDC:23243-6752-325 in 1 PAIL
    3480 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20018904/13/2017
    Labeler - Huvepharma, Inc. (619153559)
    Registrant - Huvepharma EOOD (552671651)
    Establishment
    NameAddressID/FEIBusiness Operations
    Huvepharma, Inc - St. Louis883128204analysis, label, manufacture, medicated animal feed manufacture, pack