Label: LINCOMYCIN HYDROCHLORIDE SOLUBLE POWDER- lincomycin hydrochloride powder, for solution

  • NDC Code(s): 23243-6752-1, 23243-6752-2, 23243-6752-3, 23243-6752-4, view more
    23243-6752-5, 23243-6752-6
  • Packager: Huvepharma, Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated December 14, 2024

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

  • 80 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 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)

  • 80 g front panel

    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

    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-S00054
    P08-3902BF (Rev. 03-2022)

    Take Time

  • 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.

  • 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.

  • 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

    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)

    Take Time

  • 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.

  • 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.

  • 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

    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)

    Take Time

  • 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 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.

  • 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 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.

  • 80 GRAM Packet Label Image

    80 GRAM Packet Label Image

  • 160 GRAM Packet Label Image

    160 GRAM Packet Label Image

  • 480 GRAM Packet Label Image

    480 GRAM Packet Label Image

  • INGREDIENTS AND APPEARANCE
    LINCOMYCIN HYDROCHLORIDE SOLUBLE POWDER 
    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:23243-6752-425 in 1 BOX
    280 g in 1 PACKET
    3NDC:23243-6752-220 in 1 PAIL
    3160 g in 1 PACKET
    4NDC:23243-6752-520 in 1 BOX
    4160 g in 1 PACKET
    5NDC:23243-6752-325 in 1 PAIL
    5480 g in 1 PACKET
    6NDC:23243-6752-625 in 1 BOX
    6480 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