Label: LEVAMED SOLUBLE PIG WORMER- levamisole hydrochloride powder

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated October 26, 2020

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  • DESCRIPTION

    LevaMedTM 

    (levamisole hydrochloride)

    Soluble Pig Wormer

    FOR USE IN DRINKING WATER

    Anthelmintic

    This bottle contains 18.15 grams of levamisole hydrochloride activity which will treat the following:

    200 - 25 lb pigs

    100 - 50 lb pigs

    50 - 100 lb pigs

    25 - 200 lb pigs

    NOT FOR USE IN HUMANS. KEEP OUT OF REACH OF CHILDREN.

    Restricted Drug (California) - Use Only as Directed

    Approved by FDA under ANADA # 200-313

  • SPL UNCLASSIFIED SECTION

    RECOMMENDATIONS: LevaMed™ (levamisole hydrochloride) Soluble Pig Wormer is a broad-spectrum anthelmintic and is effective against the following nematode infections in swine.

    LARGE ROUNDWORMS: (Ascaris suum)

    NODULAR WORMS: (Oesophagostomum spp.)

    LUNGWORMS: (Metastrongylus spp.)

    INTESTINAL THREADWORMS: (Strongyloides ransomi)

  • DOSAGE & ADMINISTRATION

    DIRECTIONS FOT PREPARING SOLUBLE PIG WORMER SOLUTION:

    When you are ready to worm your pigs, add water to the powder in this bottle up to the 500 ml mark. Agitate to mix thoroughly before using. If any solution is left over, it may be stored at up to 25°C for up to 3 months in this tightly capped bottle; agitate well before using.

    DATE WATER WAS ADDED TO THIS BOTTLE

    Month ____ Day ____ Year ____

    DIRECTIONS FOR USE:

    Withholding water from pigs prior to treatment is not necessary for optimum anthelmintic efficacy and is not recommended during hot weather. Add 10 ml (2 teaspoonfuls) of the solution from this bottle to 1 gallon of water; mix thoroughly. Allow one gallon of medicated water for each 100 pounds body weight of pigs to be treated. No other source of water should be offered. As soon as pigs have consumed all the medicated water, resume use of regular water.

  • WARNINGS

    OTHER WARNINGS: Parasite resistance may develop to any dewormer. All dewormers require accurate dosing for best results. Following the use of any dewormer, effectiveness of treatment should be monitored. A decrease of effectiveness over time may indicate the development of resistance to the dewormer administered. The parasite management plan should be adjusted accordingly based on regular monitoring.

    NOTE: Careful estimates of pig weights are essential for proper performance of this product.

    Pigs maintained under conditions of constant worm exposure may require retreatment within 4-5 weeks after the first treatment due to reinfection.

  • PRECAUTIONS

    CAUTION:

    Consult your veterinarian before administering LevaMed™ to sick swine. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

    Salivation or muzzle foam may be observed. This reaction is occasionally seen and will disappear in a short time after medication.

    If pigs are infected with mature lungworms, coughing and vomiting may be observed soon after medicated water is consumed. This reaction is due to the expulsion of worms from the lungs and will be over in several hours. Follow recommended dosage carefully to assure removal of worms and avoid an overdose of LevaMed™ solution.

  • RESIDUE WARNING

    RESIDUE WARNING: Do not administer within 72 hours of slaughter for food.

  • STORAGE AND HANDLING

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

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    LEVAMED SOLUBLE PIG WORMER 
    levamisole hydrochloride powder
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:61133-0280
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVAMISOLE HYDROCHLORIDE (UNII: DL9055K809) (LEVAMISOLE - UNII:2880D3468G) LEVAMISOLE20.17 g  in 20.17 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61133-0280-120.17 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20031305/13/2015
    Labeler - Bimeda, Inc. (060492923)
    Registrant - Bimeda, Inc. (060492923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bimeda, Inc.060492923manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    YangZhou Pharmaceutical Co Ltd544854599api manufacture