Label: HISTALL- pyrilamine maleate granule

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 31, 2020

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  • INDICATIONS & USAGE

    For use when an oral antihistamine is needed.

    Can be provided to horse:  1/2 ounce (1 tablespoon) per 1000lbs body weight.  Can be repeated at 12 hour intervals as needed, or as recommended by a veterinarian.  The large end of the enclosed scoop measures 1 tablespoon.

    This product contains Pyrilamine Maleate which may be prohibited in certain competition.  Caution must be taken when used on competition horse subject to drug testing.  Check with the event sanction body for the necessary withdrawal time.

  • ACTIVE INGREDIENT

    EACH OUNCE CONTAINS (minimum):  Pyrilamine Maleat USP 600mg, in a palatable base.

  • WARNINGS

    FOR ANIMAL USE ONLY.
    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
    Keep lid tightly closed and store in a dry place  Do not store above 30 C (86 F).

  • PRINCIPAL DISPLAY PANEL

    NDC#:  65090-004-15

    HistALL
    Antihistamine Granules

    Net Contents:  20 ounces (567 Gm)

    image of label

  • INGREDIENTS AND APPEARANCE
    HISTALL 
    pyrilamine maleate granule
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:65090-004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrilamine Maleate (UNII: R35D29L3ZA) (Pyrilamine - UNII:HPE317O9TL) Pyrilamine Maleate600 mg  in 28.3 g
    Inactive Ingredients
    Ingredient NameStrength
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    Dextrose (UNII: IY9XDZ35W2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Peppermint (UNII: V95R5KMY2B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65090-004-15567 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other08/23/2005
    Labeler - AHC Products Inc (169764193)
    Establishment
    NameAddressID/FEIBusiness Operations
    AHC Products, Inc.169764193manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Supriya Lifescience Ltd918527511api manufacture
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