Label: LEVAMED SOLUBLE DRENCH POWDER- levamisole hydrochloride powder

  • NDC Code(s): 61133-0270-1, 61133-0270-2, 61133-0270-3
  • Packager: Bimeda, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated November 25, 2020

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  • DESCRIPTION

    LevaMedTM

    (levamisole hydrochloride)

    Soluble Drench Powder

    CATTLE AND SHEEP DEWORMER FOR ORAL USE

    Anthelmintic

  • HOW SUPPLIED

    This Packet contains 46.8 grams of levamisole hydrochloride activity.

    Administer as a standard drench with standard drench syringe or administer as a concentrated drench solution with an automatic drenching syringe.

  • INDICATIONS & USAGE

    INDICATIONS:

    LevaMed Souble Drench Powder is a broad spectrum anthelmintic and is effective against the following adult nematode infecctions in cattle and sheep:

    SHEEP:

    STOMACH WORMS:  (Haemonchus contortus, Trichostrongylus axei, Teladorsagia circumcincta). INTESTINAL WORMS:  (Trichostrongylus colubriformis, Cooperia curticei, Nematodirus spathiger, Bonostomum trigoncephalum, Oesophagostomum columbianum, Chabertia ovina), LUNGWORMS: (Dictyocaulus filaria).

    CATTLE:

    STOMACH WORMS:  (Haemonchus placei, Trichostrongylus axei, Ostertagia ostertagi).  INTESTINAL WORMS:  (Trichostrongylus longispicularis, Cooperia oncophora, Cooperia punctata, Nematodirus spathiger, Bunostomum phlebotomum, Oesophagostomum radiatum), LUNGWORMS: (Dictyocaulus viviparus).

    NOT FOR USE IN HUMANS

    KEEP OUT OF REACH OF CHILDREN

    Restricted Drug (California) - Use Only as Directed

    Approved by FDA under ANADA 200-386

  • DOSAGE & 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 at a dose of 8 mg/kg body weight as follows:

     Weight Drench Dosage Each Packet Will Treat
     200 lb 1/2 fl oz 64 head
     400 lb 1 fl oz 32 head
     600 lb 1 1/2 fl oz 21 head
     800 lb 2 fl oz 16 head

    CONCENTRATED DRENCH SOLUTION:

    For use with 20 mL 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. Swirl until dissolved. Give 2 mL (milliliter) per 100 lb body weight. Refer to the table above for the number of cattle each packet will treat.

    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 at a dose of 8 mg/kg body weight as follows:

     Weight Drench Dosage Each Package Will Treat
     50 lb 1/2 fl oz 256 head
     100 lb 1 fl oz 128 head
     150 lb 1 1/2 fl oz 84 head
     200 lb 2 fl oz 64 head

    CONCENTRATED DRENCH SOLUTION:

    For use with 20 ml 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 each 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 at up to 25°C in clean closed containers for up to 90 days without loss of anthelmintic activity.

    Cattle and sheep maintained under conditions of constant helminth exposure may require treatment within 2 to 4 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.

  • 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 a veterinarian before using in severely debilitated animals.

  • 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.

  • STORAGE AND HANDLING

    STORAGE: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    LEVAMED SOLUBLE DRENCH POWDER 
    levamisole hydrochloride powder
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:61133-0270
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVAMISOLE HYDROCHLORIDE (UNII: DL9055K809) (LEVAMISOLE - UNII:2880D3468G) LEVAMISOLE46.8 g  in 52 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61133-0270-152 g in 1 POUCH
    2NDC:61133-0270-2403 g in 1 JUG
    3NDC:61133-0270-3605 g in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20038612/05/2014
    Labeler - Bimeda, Inc. (060492923)
    Registrant - Bimeda, Inc. (060492923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bimeda, Inc.060492923manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    YangZhou Pharmaceutical Co Ltd544854599api manufacture