Label: PROHIBIT SOLUBLE DRENCH POWDER- levamisole hydrochloride powder, for solution

  • NDC Code(s): 23243-2320-5, 23243-2320-6
  • Packager: Huvepharma, Inc
  • Category: OTC ANIMAL DRUG LABEL

Drug Label Information

Updated December 18, 2023

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  • SPL UNCLASSIFIED SECTION

    NDC 23243-2320-5
    PROHIBIT®
    (levamisole hydrochloride)
    Soluble Drench Powder
    Anthelmintic
    Each packet contains 46.8 grams of levamisole hydrochloride activity.

  • VETERINARY INDICATIONS

    CATTLE AND SHEEP DEWORMER FOR ORAL USE
    Administer as a standard drench with standard drench syringe or administer as a concentrated
    drench solution with an automatic drenching syringe.

    INDICATIONS:
    Prohibit (levamisole hydrochloride) is a broad-spectrum anthelmintic and is effective against
    the following nematode infections in cattle and sheep:

    SHEEP:
    STOMACH WORMS: Haemonchus contortus, Trichostrongylus axei, Teladorsagia circumcincta.
    INTESTINAL WORMS: Trichostrongylus colubriformis, Cooperia curticei, Nematodirus spathiger,
    Bunostomum trigonocephalum, Oesophagostomum columbianum, Chabertia ovina.
    LUNGWORMS: Dictyocaulus filaria.

    CATTLE:
    STOMACH WORMS: Haemonchus placei, Trichostrongylus axei, Ostertagia ostertagi.
    INTESTINAL WORMS: Trichostrongylus longlspicularis, Cooperia oncophora, Cooperia punctata,
    Nematodirus spathiger, Bunostomum phiebotomum, Oesophagostomum radiatum.
    LUNGWORMS: Dictyocaulus viviparus.

  • GENERAL PRECAUTIONS

    NOT FOR USE IN HUMANS
    KEEP OUT OF REACH OF CHILDREN
    Restricted Drug (California) Use Only as Directed
    Approved by FDA under ANADA # 200-225

    NET WEIGHT: 1.8 oz (52 g)

    HUVEPHARMA®

    Manufactured for Huvepharma, Inc.
    Peachtree City, GA 30269
    ®Registered Trademark of Huvepharma, Inc.

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION

     CATTLE–STANDARD DRENCH SOLUTION: Place the contents of this  packet in a 1 quart (32 fl. oz.) container, fill with water, swirl until dissolved. Administer as a single drench dose according to the following table:

     SHEEP–STANDARD DRENCH SOLUTION: Place the contents of this  packet in a 1 gallon (128 fl. oz.) container, fill with water, swirl until dissolved. Administer as a single drench dose according to the following table:

     Weight

    Drench dosage

    Packet Will Treat

     Weight

    Drench Dosage

    Packet Will Treat

     200 lb.

    1/2 fl. oz.

    64 head

     50 lb.

    1/2 fl. oz.

    256 head

     400 lb.

    1 fl. oz.

    32 head

     100 lb.

    1 fl. oz.

    128 head

     650 lb.

    1 1/2 fl. oz.

    21 head

     150 lb.

    1 1/2 fl. oz.

    84 head

     800 lb.

    2 fl. oz.

    16 head

     200 lb.

    2 fl. oz.

    64 head

     CONCENTRATED DRENCH SOLUTION: For use with automatic syringe.   Place the contents of this packet in a standard household measuring container   and add water to the 8 3/4 fl. oz. level; or use the measuring container   available from your supplier and add water to the mark. Swirl until dissolved.   Give 2 ml (milliliter) per 100 lb. body weight. Refer to the table above for the   number of cattle this packet will treat.

     CONCENTRATED DRENCH SOLUTION: For use with   automatic syringe. Place the contents of this packet in a   standard household measuring container and add water to the   17 1/2 fl. oz. level. Swirl until dissolved. Give 2 ml per 50 lb.   body weight. Refer to the table above for the number of sheep   this packet will treat.

    Do not underdose. Ensure each animal receives a complete dose based on a current body weight.
    Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.

    NOTE: Careful weight estimates are essential for proper performance of this product. Prepare solutions
    as needed. However, excess solutions may be stored in clean closed containers up to 90 days without
    loss of anthelmintic activity. Cattle and Sheep maintained under conditions of constant helminth
    exposure may require re-treatment within two to four weeks after the first treatment.

  • RESIDUE WARNING

    RESIDUE WARNING: Do not administer to cattle within 48 hours of slaughter for food. Do
    not administer to sheep within 72 hours of slaughter for food. To prevent residues in milk,
    do not administer to dairy animals of breeding age.

  • WARNINGS

    OTHER WARNINGS: Parasite resistance may develop to any dewormer, and has been
    reported for most classes of dewormers. Treatment with a dewormer used in
    conjunction with parasite management practices appropriate to the geographic
    area and the animal(s) to be treated may slow the development of parasite
    resistance. Fecal examinations or other diagnostic tests and parasite
    management history should be used to determine if the product is appropriate
    for the herd/flock, prior to the use of any dewormer. Following the use of any
    dewormer, effectiveness of treatment should be monitored (for example, with
    the use of a fecal egg count reduction test or another appropriate method).
    A decrease in a drug's effectiveness over time as calculated by fecal egg
    count reduction tests may indicate the development of resistance to the
    dewormer administered. Your parasite management plan should be adjusted
    accordingly based on regular monitoring.

  • GENERAL PRECAUTIONS

    CAUTION: Muzzle foam may be observed. However, this reaction will
    disappear within a few hours. If this condition persists, a veterinarian
    should be consulted. Follow recommended dosage carefully. Consult
    veterinarian before using in severely debilitated animals.
    Consult your veterinarian for assistance in the diagnosis, treatment,
    and control of parasitism.

  • 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.

  • STORAGE AND HANDLING

    Store between 20–25ºC (68-77ºF).    MF: L-6232-05    Rev: 03-2022
    HOW SUPPLIED: 52 g (1.8 oz) and 605 g (21.34 oz)

    LOT                      EXP.

    Take Time

  • SPL UNCLASSIFIED SECTION

    NDC 23243-2320-6
    PROHIBIT®
    (levamisole hydrochloride)
    Soluble Drench Powder
    Anthelmintic

  • VETERINARY INDICATIONS

    CATTLE AND SHEEP DEWORMER
    FOR ORAL USE
    This bottle contains 544.5 grams of
    levamisole hydrochloride activity.

  • GENERAL PRECAUTIONS

    Not For Use in Humans

    Keep Out of Reach of Children

    Restricted Drug (California) -
    Use Only as Directed

    Approved by FDA under ANADA # 200-225

    Net Wt: 21.34 oz (1.3 lb.) (605 g)

  • VETERINARY INDICATIONS

    INDICATIONS: PROHIBIT (levamisole hydrochloride) is a broad-spectrum anthelmintic and is
    effective against the following nematode infections in cattle and sheep:
    SHEEP:
    STOMACH WORMS: Haemonchus contortus, Trichostrongylus axei, Teladorsagia circumcincta.
    INTESTINAL WORMS: Trichostrongylus colubriformis, Cooperia curticei, Nematodirus spathiger,
    Bunostomum trigonocephalum, Oesophagostomum columbianum, Chabertia ovina.
    LUNGWORMS: Dictyocaulus filaria.
    CATTLE:
    STOMACH WORMS: Haemonchus placei, Trichostrongylus axei, Ostertagia ostertagi.
    INTESTINAL WORMS: Trichostrongylus longlspicularis, Cooperia oncophora, Cooperia punctata,
    Nematodirus spathiger, Bunostomum phiebotomum, Oesophagostomum radiatum.
    LUNGWORMS: Dictyocaulus viviparus.

  • RESIDUE WARNING

    RESIDUE WARNING: Do not administer to cattle within 48 hours of slaughter
    for food. Do not administer to sheep within 72 hours of slaughter for food. To
    prevent residues in milk, do not administer to dairy animals of breeding age.

  • WARNINGS

    OTHER WARNINGS: Parasite resistance may develop to any dewormer, and has been reported
    for most classes of dewormers. Treatment with a dewormer used in conjunction with parasite
    management practices appropriate to the geographic area and the animal(s) to be treated may
    slow the development of parasite resistance. Fecal examinations or other diagnostic tests and
    parasite management history should be used to determine if the product is appropriate for the
    herd/flock, prior to the use of any dewormer. Following the use of any dewormer, effectiveness
    of treatment should be monitored (for example, with the use of a fecal egg count reduction
    test or another appropriate method). A decrease in a drug's effectiveness over time as
    calculated by fecal egg count reduction tests may indicate the development of resistance to
    the dewormer administered. Your parasite management plan should be adjusted accordingly
    based on regular monitoring.

  • GENERAL PRECAUTIONS

    CAUTION: Muzzle foam may be observed. However, this reaction will disappear within a few
    hours. If this condition persists, a veterinarian should be consulted. Follow recommended
    dosage carefully. Consult veterinarian before using in severely debilitated animals.

    Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

  • STORAGE AND HANDLING

    Store between 20º-25ºC (68º-77ºF).

    HOW SUPPLIED: 52 g (1.8 oz) and 605 g (21.34 oz)

    ®Registered trademark of Huvepharma, Inc.
    Manufactured for
    Huvepharma, Inc.
    Peachtree City, GA 30269

    MF# L-6232-60

    Rev. 03-2022

    LOT.:                  EXP. DATE

    Take Time

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: When you are ready to deworm your cattle or sheep, add water to the powder in this bottle up to the 3 liter mark. Swirl to mix thoroughly before using. If any solution is left over, it may be stored for up to 3 months in this tightly capped bottle, shake well before using.

    DATE WATER WAS ADDED TO THIS BOTTLE

                                                    Month       Day       Year

    Administer as a single drench dose as follows:

    CATTLE--2 mL per 100 lb. body weight

    Weight

    Drench dosage

    Bottle

    Will Treat

    100 lb.

    2 mL

    1,500 head

    300 lb.

    6 mL

    500 head

    500 lb.

    10 mL

    300 head

    700 lb.

    14 mL

    214 head

    1,000 lb.

    20 mL

    150 head

    SHEEP--1 mL per 50 lb. body weight

    Weight

    Drench dosage

    Bottle

    Will Treat

    50 lb.

    1 mL

    3,000 head

    100 lb.

    2 mL

    1,500 head

    150 lb.

    3 mL

    1,000 head

    200 lb.

    4 mL

    750 head

    Do not underdose. Ensure each animal receives a complete dose based on a current body weight.
    Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.

    NOTE: Careful weight estimates are essential for proper performance of this
    product. Cattle and sheep maintained under conditions of constant helminth
    exposure may require retreatment within two to four weeks after the first
    treatment.

  • 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.

  • PRINCIPAL DISPLAY PANEL

    Packet Label Front

    Packet Label Back

  • PRINCIPAL DISPLAY PANEL

    HVP_Prohibit_605 g_03-2022

  • INGREDIENTS AND APPEARANCE
    PROHIBIT  SOLUBLE DRENCH POWDER
    levamisole hydrochloride powder, for solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:23243-2320
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVAMISOLE HYDROCHLORIDE (UNII: DL9055K809) (LEVAMISOLE - UNII:2880D3468G) LEVAMISOLE0.9 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23243-2320-552 g in 1 PACKET
    2NDC:23243-2320-6605 g in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20022504/20/2022
    Labeler - Huvepharma, Inc (619153559)
    Registrant - Huvepharma EOOD (552671651)