Label: ANIHIST- guafenesin and pyrilamine maleate granule

  • NDC Code(s): 65090-001-15, 65090-001-30
  • Packager: AHC Products Inc
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 13, 2014

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE

    For use when an oral antihistamine and expectorant are needed.

  • DOSAGE & ADMINISTRATION

    Can be provided to horses: 1/2 ounce (1 tablespoon) per 1000lbs body weight. Can be repeated at 12 hour intervals as needed, or as recommended by a veterinarian.

  • WARNINGS AND PRECAUTIONS

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

    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 (86F).

  • ACTIVE INGREDIENT

    ​Each ounce contains minimum:

    Guafenisen USP 2400mg, Pyrilamine Maleat USP 600mg

  • PRINCIPAL DISPLAY PANEL

    NDC 65090-001-15

    AniHist

    antihistamine

    expectorant

    Net Contents: 20 ounces (567 gm)

    image of jar label

  • INGREDIENTS AND APPEARANCE
    ANIHIST 
    guafenesin and pyrilamine maleate granule
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:65090-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN2400 mg  in 28.3 g
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE600 mg  in 28.3 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65090-001-15566 g in 1 JAR
    2NDC:65090-001-302264 g in 1 PAIL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/13/1999
    Labeler - AHC Products Inc (169764193)
    Establishment
    NameAddressID/FEIBusiness Operations
    AHC Products Inc169764193manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Gennex Laboratories Limited916636327api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Supriya Lifescience Ltd.650457729api manufacture