<?xml version="1.0" encoding="UTF-8"?><?xml-stylesheet href="https://www.accessdata.fda.gov/spl/stylesheet/spl.xsl" type="text/xsl"?>
<document xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="urn:hl7-org:v3 https://www.accessdata.fda.gov/spl/schema/spl.xsd">
   <id root="1a980ec0-0b24-4220-ae61-b53271a8783f"/>
   <code code="50575-0" codeSystem="2.16.840.1.113883.6.1" displayName="VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL"/>
   <title>
      <content styleCode="bold"/>
   </title>
   <effectiveTime value="20260106"/>
   <setId root="0cb546ce-5db1-47a7-85b0-b6800ecb3315"/>
   <versionNumber value="5"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id extension="966985624" root="1.3.6.1.4.1.519.1"/>
            <name>Elanco US Inc.</name>
            <assignedEntity>
               <assignedOrganization/>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="fb115dc9-3063-4fb3-ac2e-4d700cf4272b"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <effectiveTime value="20251224"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="58198-0099" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Tylan 100</name>
                        <formCode code="C42938" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="GRANULE"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>tylosin phosphate</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator unit="g" value="100"/>
                              <denominator unit="kg" value=".45"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="NR75X12AFF" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>tylosin phosphate</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="YEF4JXN031" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>tylosin</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator unit="kg" value="22.68"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="58198-0099-1" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43167" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BAG"/>
                           </containerPackagedProduct>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <approval>
                           <id extension="NADA012491" root="2.16.840.1.113883.3.150"/>
                           <code code="C73593" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="NADA"/>
                           <author>
                              <territorialAuthority>
                                 <territory>
                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                 </territory>
                              </territorialAuthority>
                           </author>
                        </approval>
                     </subjectOf>
                     <subjectOf>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20100108"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/>
                        </substanceAdministration>
                     </consumedIn>
                  </manufacturedProduct>
               </subject>
            </section>
         </component>
         <component>
            <section ID="s1">
               <id root="fef384e3-ada5-4ea2-a232-75764ed2af93"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>AF0099 <br/>BG102345X<br/>
                     <content styleCode="bold">
                        <content styleCode="italics">Elanco</content>™</content>
                     <br/>
                     <content styleCode="bold">
                        <content styleCode="italics">Tylan™ 100</content>
                     </content>
                  </paragraph>
                  <paragraph>Net Weight: <content styleCode="bold">50 lbs</content>
                     <br/>(22.68 kg) </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Tylosin Phosphate</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Type A Medicated Article</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION:</content> Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. </paragraph>
                  <paragraph>
                     <content styleCode="bold">For use in Swine and Beef Cattle Feeds Only</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Do Not Feed Undiluted</content>
                  </paragraph>
                  <paragraph>Equivalent to <content styleCode="bold">100 g</content> Tylosin per Pound </paragraph>
               </text>
               <effectiveTime value="20251224"/>
            </section>
         </component>
         <component>
            <section ID="s2">
               <id root="ca31fb18-c395-4fc9-a810-ab0ebbcc966e"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Swine: </title>
               <text>
                  <paragraph>For reduction in severity of effects of atrophic rhinitis. </paragraph>
                  <paragraph>For control of swine dysentery associated with <content styleCode="italics">Brachyspira hyodysenteriae.</content>
                  </paragraph>
                  <paragraph>For the treatment and control of swine dysentery associated with <content styleCode="italics">Brachyspira hyodysenteriae</content> immediately after medicating with <content styleCode="bold">Tylan Soluble</content> (tylosin) drinking water. </paragraph>
                  <paragraph>For control of porcine proliferative enteropathies (PPE, ileitis) associated with <content styleCode="italics">Lawsonia intracellularis.</content>
                  </paragraph>
                  <paragraph>For control of porcine proliferative enteropathies (PPE, ileitis) associated with <content styleCode="italics">Lawsonia intracellularis</content> immediately after medicating with <content styleCode="bold">Tylan Soluble</content> (tylosin) in drinking water. </paragraph>
               </text>
               <effectiveTime value="20251224"/>
            </section>
         </component>
         <component>
            <section ID="s3">
               <id root="beaf7260-150f-4128-94b2-d56d6e367c64"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Beef Cattle: </title>
               <text>
                  <paragraph>For reduction of incidence of liver abscesses associated with <content styleCode="italics">Fusobacterium necrophorum</content> and <content styleCode="italics">Arcanobacterium pyogenes</content>. </paragraph>
                  <paragraph>
                     <content styleCode="bold">Restricted Drug (California) - Use Only as Directed.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Approved by FDA under NADA # 012-491</content>
                  </paragraph>
                  <paragraph>Tylan, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. </paragraph>
                  <paragraph>Manufactured For: </paragraph>
                  <paragraph>
                     <content styleCode="bold">Elanco US Inc.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Greenfield, IN 46140, USA</content>
                  </paragraph>
                  <paragraph>To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441. </paragraph>
                  <paragraph>AF0099<br/>BG102345X </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Elanco</content>™</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Tylan</content>™ <content styleCode="italics">100 </content>Tylosin Phosphate</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Directions for Use</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Read All Directions Carefully Before Mixing and Feeding</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Tylan 100 Type A Medicated Article</content>
                  </paragraph>
                  <paragraph>Net Weight <content styleCode="bold">50 lbs</content> (22.68 kg) </paragraph>
                  <paragraph>
                     <content styleCode="bold">Do Not Feed Undiluted.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.</content>
                  </paragraph>
               </text>
               <effectiveTime value="20251224"/>
            </section>
         </component>
         <component>
            <section ID="s4">
               <id root="c640b3e9-a3fa-4f7a-bb48-2e87489ac492"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Active Drug Ingredient</content>—Tylosin (as tylosin phosphate) . . . 100 g per lb </paragraph>
               </text>
               <effectiveTime value="20251224"/>
            </section>
         </component>
         <component>
            <section ID="s5">
               <id root="c9253b64-e79e-4d57-8835-295cf17784c8"/>
               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Ingredients:</content> Roughage products, calcium carbonate and mineral oil. </paragraph>
                  <paragraph>
                     <content styleCode="bold">Caution:</content> To ensure adequate mixing, an intermediate blending step should be used prior to manufacturing a complete feed. Do not use in any liquid feed containing sodium metabisulfite or in any finished feed (supplement, concentrate or complete feed) containing in excess of 2% bentonite. </paragraph>
               </text>
               <effectiveTime value="20251224"/>
            </section>
         </component>
         <component>
            <section ID="s6">
               <id root="bc324dd1-564e-47c2-8e71-f9f70ff7c551"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Warning: Tylan 100</content> may be irritating to unprotected skin and eyes. When mixing and handling <content styleCode="bold">Tylan 100</content> use protective clothing, impervious gloves and a dust respirator. In case of accidental eye exposure, flush eyes with plenty of water. Exposed skin should be washed with plenty of soap and water. Remove and wash contaminated clothing. Seek medical attention if irritation becomes severe or persists. The material safety data sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441. </paragraph>
               </text>
               <effectiveTime value="20251224"/>
               <component>
                  <section ID="s7">
                     <id root="6518ee5a-aa8b-4d63-830c-1629fc7c4a21"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">For reduction in severity of effects of atrophic rhinitis.</content> Feed 100 g of tylosin per ton (1.0 pound <content styleCode="bold">Tylan 100</content> per ton) of complete feed. Feed continuously as the sole ration. </paragraph>
                     </text>
                     <effectiveTime value="20251224"/>
                  </section>
               </component>
               <component>
                  <section ID="s8">
                     <id root="c88a885f-2db5-4259-85ea-29aba00dbcaa"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">For control of swine dysentery.</content> Feed 100 g of tylosin per ton (1.0 pound <content styleCode="bold">Tylan 100</content> per ton) of complete feed for at least three weeks. Follow with 40 g tylosin per ton (0.4 pound <content styleCode="bold">Tylan 100</content> per ton) of complete feed until pigs reach market weight. </paragraph>
                     </text>
                     <effectiveTime value="20251224"/>
                  </section>
               </component>
               <component>
                  <section ID="s9">
                     <id root="9f5edbb1-efbf-46a4-bbb5-3dbdc69502a5"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">For the treatment and control of swine dysentery.</content> Feed 40 to 100 grams of tylosin (0.4 to 1.0 pounds of <content styleCode="bold">Tylan 100</content>) per ton of complete feed for 2 to 6 weeks immediately after medicating with 250 mg tylosin (as <content styleCode="bold">Tylan Soluble</content>) per gallon in drinking water for 3 to 10 days. </paragraph>
                     </text>
                     <effectiveTime value="20251224"/>
                  </section>
               </component>
               <component>
                  <section ID="s10">
                     <id root="9e6a1587-51c5-4a42-8de3-6fd0dd6a82b2"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">For control of porcine proliferative enteropathies (PPE, ileitis).</content> Feed 100 g of tylosin per ton (1.0 pound <content styleCode="bold">Tylan 100</content> per ton) of complete feed for 21 days. Alternatively, feed 100 g of tylosin per ton (1.0 pound <content styleCode="bold">Tylan 100</content> per ton) of complete feed for at least three weeks, followed by 40 g tylosin per ton of complete feed until pigs reach market weight. Alternatively, feed 40 to 100 grams of tylosin (0.4 to 1.0 pounds of <content styleCode="bold">Tylan 100</content>) per ton of complete feed for 2 to 6 weeks immediately after medicating with 250 mg tylosin (as <content styleCode="bold">Tylan Soluble</content>) per gallon in drinking water for 3 to 10 days. Feed continuously as the sole ration when feeding Tylan. </paragraph>
                        <paragraph>
                           <content styleCode="bold">NOTICE: Organisms vary in their degree of susceptibility to any chemotherapeutic. If no improvement is observed after recommended treatment, diagnosis and susceptibility should be reconfirmed.</content>
                        </paragraph>
                        <table width="100%">
                           <col width="27%"/>
                           <col width="37%"/>
                           <col width="36%"/>
                           <tbody>
                              <tr>
                                 <td rowspan="4" styleCode="Rrule Botrule Lrule Toprule " valign="top">
                                    <paragraph>
                                       <content styleCode="bold">Mixing and Feeding</content>
                                       <br/>
                                       <content styleCode="bold">Directions for</content>
                                       <br/>
                                       <content styleCode="bold">Beef Cattle Feeds</content>
                                       <br/>For reduction of incidence of liver abscesses in beef cattle associated with <content styleCode="italics">Fusobacterium necrophorum</content> and <content styleCode="italics">Arcanobacterium pyogenes.</content>
                                    </paragraph>
                                 </td>
                                 <td align="center" styleCode="Rrule Botrule Toprule " valign="top">
                                    <paragraph>
                                       <content styleCode="bold">Tylan 100</content> Per Ton Of Type C Feed </paragraph>
                                 </td>
                                 <td align="center" styleCode="Rrule Botrule Toprule " valign="top">
                                    <paragraph>Tylosin Per Ton Of Type C Feed </paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td align="center" styleCode="Rrule " valign="top">
                                    <paragraph>0.08 to 0.10 lbs </paragraph>
                                 </td>
                                 <td align="center" styleCode="Rrule " valign="top">
                                    <paragraph>8 to 10 g </paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td styleCode="Rrule " valign="top">
                                    <paragraph>To be fed so that each animal receives not more than 90 mg per head per day and not less than 60 mg per head per day.<br/>
                                    </paragraph>
                                 </td>
                                 <td styleCode="Rrule " valign="top"/>
                              </tr>
                              <tr>
                                 <td align="center" styleCode="Rrule Botrule " valign="top">
                                    <paragraph>Feed continuously as the sole ration. </paragraph>
                                 </td>
                                 <td styleCode="Rrule Botrule " valign="top"/>
                              </tr>
                              <tr>
                                 <td styleCode="Rrule Botrule Lrule " valign="top">
                                    <paragraph>
                                       <content styleCode="bold">Mixing Directions for</content>
                                       <br/>
                                       <content styleCode="bold">Liquid Type B</content>
                                       <br/>
                                       <content styleCode="bold">Cattle Feeds</content>
                                    </paragraph>
                                 </td>
                                 <td colspan="2" styleCode="Rrule Botrule " valign="top">
                                    <paragraph>
                                       <content styleCode="bold">LIMITATIONS:</content>
                                       <br/>
                                    </paragraph>
                                    <list listType="ordered">
                                       <item>
                                          <caption>1.</caption>pH must be between 4.5 and 6.0. </item>
                                       <item>
                                          <caption>2.</caption>For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. </item>
                                       <item>
                                          <caption>3.</caption>For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used. </item>
                                       <item>
                                          <caption>4.</caption>Liquid Type B Cattle Feeds must bear an expiration date of 31 days after the date of manufacture. </item>
                                    </list>
                                 </td>
                              </tr>
                           </tbody>
                        </table>
                        <paragraph>
                           <content styleCode="bold">NOT FOR HUMAN USE</content>
                        </paragraph>
                     </text>
                     <effectiveTime value="20251224"/>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section ID="s11">
               <id root="6e411117-6d42-4eae-9bf8-0d4d8c6e0f57"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Store at Room Temperature, 25°C (77°F). Avoid moisture.</content>
                     <br/>
                     <content styleCode="bold">Not to be used after the date printed on the bottom of the bag.</content>
                  </paragraph>
                  <renderMultiMedia ID="f01" referencedObject="mm01"/>
               </text>
               <effectiveTime value="20251224"/>
               <component>
                  <observationMedia ID="mm01">
                     <text>Logo
</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="tyl08-0003-01.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="s12">
               <id root="c152464e-075a-43c2-8151-c9cb7711ee1e"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Principal Display Panel - 50 lbs Bag Label </title>
               <text>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Elanco</content>™</content>
                     <br/>
                     <content styleCode="bold">
                        <content styleCode="italics">Tylan</content>™ <content styleCode="italics">100</content>™</content>
                  </paragraph>
                  <paragraph>Net Weight: <content styleCode="bold">50 lbs</content>
                     <br/>(22.68 kg) </paragraph>
                  <paragraph>Tylosin Phosphate </paragraph>
                  <paragraph>
                     <content styleCode="bold">Type A Medicated Article</content>
                  </paragraph>
                  <renderMultiMedia ID="f02" referencedObject="mm02"/>
               </text>
               <effectiveTime value="20251224"/>
               <component>
                  <observationMedia ID="mm02">
                     <text>Principal Display Panel - 50 lbs Bag Label
</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="tyl08-0003-02.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>