Label: SPECTOGARD SCOUR-CHEK- spectinomycin solution

  • NDC Code(s): 61133-6002-5, 61133-6002-6, 61133-6002-7
  • Packager: Bimeda, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated November 20, 2019

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  • DESCRIPTION

    Liquid

    SpectoGard®
    Scour-Chek®
    (spectinomycin)

    ORAL SOLUTION FOR PIG SCOURS

    Anti-infective

    NOT FOR USE IN HUMANS

    KEEP OUT OF REACH OF CHILDREN

    Restricted Drug (California) – Use Only As Directed

    ANADA 200-364, Approved by FDA

  • INDICATIONS & USAGE

    INDICATIONS: For use in pigs under four (4) weeks of age for treatment and control of porcine enteric colibacillosis (scours) caused by E. coli susceptible to spectinomycin.

    EACH mL CONTAINS: Spectinomycin (from spectinomycin dihydrochloride pentahydrate)...................50 mg

  • RESIDUE WARNING

    RESIDUE WARNINGS: This product is only intended for use in pigs under four (4) weeks of age or weighing less than 15 lbs.
    Do not administer within 21 days of slaughter.

  • STORAGE AND HANDLING

    Store at controlled room temperature 20°C - 25°C (68°F - 77°F), with excursions permitted to 15°C - 30°C (59°F - 86°F).

  • DOSAGE & ADMINISTRATION

    DOSE: Pigs under 10 lbs. - 1 pump (1 mL) twice daily.

    Pigs over 10 lbs. - 2 pumps (2 mL) twice daily.

    Each pump of the plunger delivers 1 mL of solution containing 50 mg of spectinomycin. Treatment may be continued twice daily for 3 to 5 days. If pigs do not improve within 48 hours, rediagnosis is suggested.

    DIRECTIONS FOR USE: The plastic doser supplied in each package with SpectoGard® Scour-Chek® makes treatment easy. After inserting the doser in the bottle, screw the top on tightly to avoid spilling. Push the piece of clear plastic tubing over the end of the pump. Then press the plunger a few times to fill the pump and the clear plastic tube with medication. To administer SpectoGard® Scour-Chek®, insert the plastic tube in the pig's mouth and press the plunger to obtain the desired dose.

    When not in use remove the plunger from the bottle. Put the clear plastic tube in the neck of the bottle and press the plunger a few times to remove the medication from the pump. Replace the original cap on the bottle and always rinse out the doser with water to prevent sticking.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SPECTOGARD SCOUR-CHEK 
    spectinomycin solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:61133-6002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Spectinomycin (UNII: 93AKI1U6QF) (Spectinomycin - UNII:93AKI1U6QF) Spectinomycin50 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61133-6002-53785 mL in 1 BOTTLE
    2NDC:61133-6002-71000 mL in 1 BOTTLE
    3NDC:61133-6002-6240 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20036407/09/2004
    Labeler - Bimeda, Inc. (060492923)
    Registrant - Bimeda, Inc. (060492923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bimeda, Inc.060492923manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Shandong Qilu King-phar Parmaceutical Co., Ltd.421524323api manufacture