Animal NDC 65090-004-15 Histall

Pyrilamine Maleate

Animal Product Information

Field Name Field Value
Animal NDC Code 65090-004-15
Proprietary Name Histall What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Pyrilamine Maleate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Ahc Products Inc
Product Type Otc Animal Drug
Usage Information
    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(s)
  • Pyrilamine Maleate
Inactive Ingredient(s)
  • SACCHAROMYCES CEREVISIAE (978D8U419H)
  • DEXTROSE (IY9XDZ35W2)
  • STARCH, CORN (O8232NY3SJ)
  • PEPPERMINT (V95R5KMY2B)
  • SACCHAROMYCES CEREVISIAE (978D8U419H)
  • DEXTROSE (IY9XDZ35W2)
  • STARCH, CORN (O8232NY3SJ)
  • PEPPERMINT (V95R5KMY2B)
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Histall Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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.


Otc - 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).


Package Label.Principal Display Panel



NDC#:  65090-004-15

HistALL
Antihistamine Granules

Net Contents:  20 ounces (567 Gm)


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.