<?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="5de7d365-8c37-45f5-8567-f200bab92763"/>
   <code code="50578-4" codeSystem="2.16.840.1.113883.6.1" displayName="PRESCRIPTION ANIMAL DRUG LABEL"/>
   <title>
      <content styleCode="bold"> </content>
   </title>
   <effectiveTime value="20251121"/>
   <setId root="0c3d01b7-be57-4031-adbe-5dbdd2a6d7f2"/>
   <versionNumber value="7"/>
   <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="9973c3b3-9b43-45ba-8852-0dab583a0336"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <effectiveTime value="20241217"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="58198-1300" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Tylan Soluble</name>
                        <formCode code="C42972" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="POWDER"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>tylosin tartrate</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator unit="g" value="100"/>
                              <denominator unit="mL" value="3785"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="5P4625C51T" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>tylosin tartrate</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="mL" value="3785"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="58198-1300-1" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43173" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE, PLASTIC"/>
                           </containerPackagedProduct>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <approval>
                           <id extension="NADA013076" 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="20111223"/>
                           </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="s0">
               <id root="f4879f36-4892-4753-9a8a-b737850d2a42"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Elanco™</content>
                  </paragraph>
                  <paragraph>AF1300 </paragraph>
                  <paragraph>
                     <content styleCode="bold">Tylan™ Soluble<sub>TM</sub>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Tylosin Tartrate</content>
                  </paragraph>
                  <paragraph>Equivalent to <content styleCode="bold">100 g (3.53 oz)</content> tylosin base</paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION:</content> Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. </paragraph>
                  <paragraph>For oral use in chickens, turkeys, swine, and honey bees. </paragraph>
                  <paragraph>Macrolide Antibiotic</paragraph>
                  <paragraph>Approved by FDA under NADA # 013-076</paragraph>
               </text>
               <effectiveTime value="20241217"/>
            </section>
         </component>
         <component>
            <section ID="s1">
               <id root="7d38a308-b57b-4fa3-a869-a1cfeb7846d8"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>Indications</title>
               <effectiveTime value="20241217"/>
               <component>
                  <section ID="s2">
                     <id root="e7c68678-bb2c-4585-89b0-a060905b3923"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Chickens:</content> For the control of mortality caused by necrotic enteritis (<content styleCode="bold">NE</content>) associated with <content styleCode="italics">Clostridium perfringens</content> in broiler chickens. As an aid in the treatment of chronic respiratory disease (<content styleCode="bold">CRD</content>) associated with <content styleCode="italics">Mycoplasma gallisepticum</content> in broiler and replacement chickens. For the control of CRD associated with <content styleCode="italics">Mycoplasma gallisepticum</content> at the time of vaccination or other stress in chickens. For the control of CRD associated with <content styleCode="italics">Mycoplasma synoviae</content> in broiler chickens.</paragraph>
                     </text>
                     <effectiveTime value="20241217"/>
                  </section>
               </component>
               <component>
                  <section ID="s3">
                     <id root="da96f4a9-ee56-42c9-bd52-47e1fa40a0aa"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Turkeys:</content> For the reduction in severity of effects of infectious sinusitis associated with <content styleCode="italics">Mycoplasma gallisepticum</content>. </paragraph>
                     </text>
                     <effectiveTime value="20241217"/>
                  </section>
               </component>
               <component>
                  <section ID="s4">
                     <id root="221c7fd9-b50e-4f70-a63b-ee777f1d509c"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Swine:</content> For the treatment and control of swine dysentery (<content styleCode="bold">SD</content>) associated with <content styleCode="italics">Brachyspira hyodysenteriae</content>. For the treatment and control of SD associated with <content styleCode="italics">Brachyspira hyodysenteriae</content> when followed immediately by Tylan Type A medicated article in feed. For the control of porcine proliferative enteropathies (<content styleCode="bold">PPE</content>, ileitis) associated with <content styleCode="italics">Lawsonia intracellularis</content> when followed immediately by Tylan Type A medicated article in feed.</paragraph>
                     </text>
                     <effectiveTime value="20241217"/>
                  </section>
               </component>
               <component>
                  <section ID="s5">
                     <id root="9c4a113d-95ec-4066-9302-2e592847e7cb"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Honey Bees:</content> For the control of American Foulbrood (<content styleCode="italics">Paenibacillus larvae</content>).</paragraph>
                     </text>
                     <effectiveTime value="20241217"/>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section ID="ID_32bca3fc-8345-4397-997e-2ec07b04f62d">
               <id root="9d7f5761-38b1-4c36-8d6d-3291117815a3"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Ingredients </title>
               <text>
                  <paragraph>Tylosin (as tylosin tartrate).........................................................................................100 g </paragraph>
               </text>
               <effectiveTime value="20241217"/>
            </section>
         </component>
         <component>
            <section ID="s6">
               <id root="6b375d50-0bb9-45e2-b0b0-019136df747a"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>Dosage and Administration</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Dosages:</content>
                  </paragraph>
               </text>
               <effectiveTime value="20241217"/>
               <component>
                  <section ID="s7">
                     <id root="4a32bce9-5df7-47ab-8962-e112b19f74a9"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>   Chickens:</title>
                     <effectiveTime value="20241217"/>
                     <component>
                        <section ID="s8">
                           <id root="58c8e38c-bf94-4e87-9352-e094935418ca"/>
                           <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                           <text>
                              <paragraph>      <content styleCode="bold">NE indication:</content> 851 to 1,419 mg/gallon (225 to 375 ppm) in drinking water. </paragraph>
                           </text>
                           <effectiveTime value="20241217"/>
                        </section>
                     </component>
                     <component>
                        <section ID="s9">
                           <id root="06d99724-fb7f-4d3a-a354-f9975223a4ae"/>
                           <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                           <text>
                              <paragraph>      <content styleCode="bold">CRD indications:</content> 2,000 mg/gallon (528 ppm) in drinking water. </paragraph>
                           </text>
                           <effectiveTime value="20241217"/>
                        </section>
                     </component>
                     <component>
                        <section ID="s10">
                           <id root="671ad549-bbb8-46a4-9356-85ab2384caab"/>
                           <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                           <text>
                              <paragraph>   <content styleCode="bold">Turkeys:</content> 2,000 mg/gallon (528 ppm) in drinking water. </paragraph>
                           </text>
                           <effectiveTime value="20241217"/>
                        </section>
                     </component>
                     <component>
                        <section ID="s11">
                           <id root="9839a999-d0cd-4a30-bc9d-ce413b652492"/>
                           <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                           <text>
                              <paragraph>   <content styleCode="bold">Swine:</content> 250 mg/gallon (66 ppm) in drinking water. </paragraph>
                           </text>
                           <effectiveTime value="20241217"/>
                        </section>
                     </component>
                     <component>
                        <section ID="s12">
                           <id root="e0b7ce94-6c9b-45a2-af91-36e8f61ab64d"/>
                           <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                           <text>
                              <paragraph>   <content styleCode="bold">Honey Bees:</content> 200 mg/colony in confectioners/powdered sugar. </paragraph>
                           </text>
                           <effectiveTime value="20241217"/>
                        </section>
                     </component>
                  </section>
               </component>
               <component>
                  <section ID="s13">
                     <id root="c6653d12-f90a-4fe7-b1ae-b4736cb121c2"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Mixing Directions for Medicated Drinking Water:</title>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Always</content> add the water to the powder. Do not pour the powder into the water. Prepare a fresh Tylan Soluble solution every three days. When mixing and handling tylosin, use protective clothing and impervious gloves. If using a water medicating pump see table below, otherwise mix as follows: <br/>To assure thorough dissolution, first place the contents of one jar in a mixing container and add one gallon of water (3785 mL) to the powder to make a concentrated solution. To make medicated drinking water containing 250 mg/gallon (66 ppm), mix this concentrated solution with water to make 400 gallons (1514 liters) of medicated drinking water. To make medicated drinking water containing 851 to 1,419 mg/gallon (225 to 375 ppm), mix this concentrated solution with water to make from 117 gallons + 51 ounces (444 liters) to 70 gallons + 64 ounces (267 liters) of medicated drinking water, respectively. To make medicated drinking water containing 2,000 mg/gallon (528 ppm), mix this concentrated solution with water to make 50 gallons (189 liters) of medicated drinking water. </paragraph>
                        <table ID="_Reft300" width="100%">
                           <caption>Mixing Directions for Water Medicating Pump (1:128 inclusion)*: </caption>
                           <col width="35%"/>
                           <col width="33%"/>
                           <col width="29%"/>
                           <tfoot>
                              <tr>
                                 <td align="left" colspan="3" valign="top">*This table applies only if the water medicating pump is set to deliver 1 ounce of stock solution per gallon of drinking water. </td>
                              </tr>
                           </tfoot>
                           <tbody>
                              <tr>
                                 <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top">
                                    <paragraph>Desired Concentration <br/>in Drinking water </paragraph>
                                 </td>
                                 <td align="center" styleCode="Rrule Botrule Toprule " valign="top">
                                    <paragraph>Jars of <br/>Tylan Soluble </paragraph>
                                 </td>
                                 <td align="center" styleCode="Rrule Botrule Toprule " valign="top">
                                    <paragraph>Volume of Water to Make<br/>Stock Solution </paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td align="center" styleCode="Rrule Lrule Botrule " valign="top">
                                    <paragraph>250 mg/gallon (66 ppm) </paragraph>
                                 </td>
                                 <td align="center" styleCode="Rrule Botrule " valign="top">
                                    <paragraph>1 </paragraph>
                                 </td>
                                 <td align="center" styleCode="Rrule Botrule " valign="top">
                                    <paragraph>3 gallons + 13 ounces </paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td align="center" styleCode="Rrule Lrule Botrule " valign="top">
                                    <paragraph>851 mg/gallon (225 ppm) </paragraph>
                                 </td>
                                 <td align="center" styleCode="Rrule Botrule " valign="top">
                                    <paragraph>5 </paragraph>
                                 </td>
                                 <td align="center" styleCode="Rrule Botrule " valign="top">
                                    <paragraph>4 gallons + 77 ounces </paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td align="center" styleCode="Rrule Lrule Botrule " valign="top">
                                    <paragraph>1,419 mg/gallon (375 ppm) </paragraph>
                                 </td>
                                 <td align="center" styleCode="Rrule Botrule " valign="top">
                                    <paragraph>9 </paragraph>
                                 </td>
                                 <td align="center" styleCode="Rrule Botrule " valign="top">
                                    <paragraph>5 gallons + 0 ounces </paragraph>
                                 </td>
                              </tr>
                              <tr>
                                 <td align="center" styleCode="Rrule Botrule Lrule " valign="top">
                                    <paragraph>2,000 mg/gallon (528 ppm) </paragraph>
                                 </td>
                                 <td align="center" styleCode="Rrule Botrule " valign="top">
                                    <paragraph>10 </paragraph>
                                 </td>
                                 <td align="center" styleCode="Rrule Botrule " valign="top">
                                    <paragraph>3 gallons + 115 ounces </paragraph>
                                 </td>
                              </tr>
                           </tbody>
                        </table>
                     </text>
                     <effectiveTime value="20241217"/>
                     <component>
                        <section ID="s14">
                           <id root="9b4924cc-54d1-4e34-ab08-c72310d15ee6"/>
                           <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                           <text>
                              <paragraph>
                                 <content styleCode="bold">Mixing Directions for use in Honey Bees:</content> Mix 200 mg tylosin in 20 g confectioners/powdered sugar. Use immediately. </paragraph>
                           </text>
                           <effectiveTime value="20241217"/>
                        </section>
                     </component>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section ID="s15">
               <id root="59e7fcb8-acdd-4837-8ad2-820ca18e68b0"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Directions for Use</title>
               <effectiveTime value="20241217"/>
               <component>
                  <section ID="s16">
                     <id root="2da3dbca-e993-45ae-a699-574592c8722c"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Chickens: NE indication:</content> Administer medicated drinking water for a single five day period in broiler chickens. To assure all birds receive the intended medication, only medicated water should be available. These practices should be followed to assure both food safety and responsible antimicrobial drug use in chickens: 1) Use in flocks exhibiting signs of a necrotic enteritis outbreak, for example, increased mortality and lesions characteristic of necrotic enteritis upon necropsy; 2) Administer the full dose and dosing regimen once medication is initiated; 3) Use of Tylan Soluble or another macrolide is not advised if additional therapy is needed beyond the original course of medication. <content styleCode="bold">CRD indications:</content> Administer medicated drinking water for three days; however, medicated water may be administered for one to five days depending upon severity of infection. Treated chickens must consume enough medicated water to provide 50 mg per pound of body weight per day. Only medicated water should be available to the birds. </paragraph>
                     </text>
                     <effectiveTime value="20241217"/>
                  </section>
               </component>
               <component>
                  <section ID="s17">
                     <id root="4134b965-e0ce-4d5a-97d0-754a5bb738dd"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Turkeys:</content> Administer medicated drinking water for three days; however, medicated water may be administered for two to five days depending upon severity of infection. Treated turkeys must consume enough medicated water to provide 60 mg per pound of body weight per day. Only medicated water should be available to the birds. </paragraph>
                     </text>
                     <effectiveTime value="20241217"/>
                  </section>
               </component>
               <component>
                  <section ID="s18">
                     <id root="e2c646b9-4986-4bb8-a6fa-9f84e6af35dc"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Swine: SD indication:</content> Administer medicated drinking water for 3 to 10 days, depending upon severity of infection. Alternatively, administer medicated drinking water for 3 to 10 days, followed by 40 to 100 g tylosin per ton of complete feed (Type C medicated feed manufactured from Tylan Type A medicated article) for 2 to 6 weeks. Only medicated water should be available to swine while medicating with Tylan Soluble. <content styleCode="bold">PPE indication:</content> Administer medicated drinking water for 3 to 10 days, followed by 40 to 100 g of tylosin per ton of complete feed (Type C medicated feed manufactured from Tylan A medicated article) for 2 to 6 weeks. Only medicated water should be available to swine while medicating with Tylan Soluble. </paragraph>
                     </text>
                     <effectiveTime value="20241217"/>
                  </section>
               </component>
               <component>
                  <section ID="s19">
                     <id root="1a6441d4-979a-4328-ae9a-4bc75e4c6add"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Honey Bee Colonies:</content> Administer three treatments of medicated confectioners sugar once weekly for 3 weeks. The 200 mg dose is applied (dusted) over the top bars of the brood chamber. </paragraph>
                     </text>
                     <effectiveTime value="20241217"/>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section ID="s20">
               <id root="35276a29-d8fb-483c-8705-1007c2d582b4"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>Warnings</title>
               <effectiveTime value="20241217"/>
               <component>
                  <section ID="s21">
                     <id root="509bd813-cdf1-4f2a-a7e5-0aa42640c8f6"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">User Safety Warnings:</content> Not for Human Use. Keep Out of Reach of Children. Avoid contact with human skin. Exposure to tylosin may cause a rash. </paragraph>
                     </text>
                     <effectiveTime value="20241217"/>
                  </section>
               </component>
               <component>
                  <section ID="s22">
                     <id root="f79b0bcf-3c74-4d8e-aa33-a54332f74004"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>      <content styleCode="bold">Residue Warnings: Chickens</content> must not be slaughtered for food within 24 hours after treatment. Do not use in layers producing eggs for human consumption. </paragraph>
                     </text>
                     <effectiveTime value="20241217"/>
                  </section>
               </component>
               <component>
                  <section ID="s23">
                     <id root="132cf8cf-68ff-49f3-a498-9ecce0e568f6"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>      <content styleCode="bold">Turkeys</content> must not be slaughtered for food within five days after treatment.<br/>      Do not use in layers producing eggs for human consumption.</paragraph>
                     </text>
                     <effectiveTime value="20241217"/>
                  </section>
               </component>
               <component>
                  <section ID="s24">
                     <id root="5439f708-6733-4125-8cce-5b60ca6ae805"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>      <content styleCode="bold">Swine</content> must not be slaughtered for food within 48 hours after treatment. </paragraph>
                     </text>
                     <effectiveTime value="20241217"/>
                  </section>
               </component>
               <component>
                  <section ID="s25">
                     <id root="34e6c4ae-2131-4e21-8328-12a76e6c3401"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <text>
                        <paragraph>      <content styleCode="bold">Honey bees:</content> The drug should be fed early in the spring or fall and consumed by the bees before the main honey flow begins, to avoid contamination of production honey. Complete treatments at least 4 weeks prior to main honey flow. </paragraph>
                        <paragraph>
                           <content styleCode="bold">Manufactured For:</content>
                           <br/>
                           <content styleCode="bold">Elanco US, Inc.                                                                                 Store at or below 25°C (77°F)</content>
                           <br/>
                           <content styleCode="bold">Greenfield, IN 46140 U.S.A.                                                            Excursions Permitted to 40°C (104°F)</content>
                           <br/>
                           <content styleCode="bold">Product of the United Kingdom                                                      Avoid Moisture.</content>
                        </paragraph>
                     </text>
                     <effectiveTime value="20241217"/>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section ID="s26">
               <id root="8fb6734d-018b-4158-823f-0ae4f16bcbb1"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Elanco US, Inc. at 1-888-545-5973. </content>
                     <br/>
                     <content styleCode="bold">For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or <linkHtml href="http://www.fda.gov/reportanimalae">http://www.fda.gov/reportanimalae</linkHtml>.</content>
                  </paragraph>
                  <paragraph>Tylan, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.</paragraph>
                  <paragraph>© 2022 Elanco or its affiliates</paragraph>
                  <paragraph>Lot/Exp. date </paragraph>
                  <paragraph>47801-07</paragraph>
                  <paragraph>YL103717X</paragraph>
               </text>
               <effectiveTime value="20241217"/>
            </section>
         </component>
         <component>
            <section ID="s27">
               <id root="b8c6182f-e2d9-41b2-97f5-25af1d77b803"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Principal Display Panel - Tylan Soluble Bottle Label </title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Elanco™</content>
                  </paragraph>
                  <paragraph>AF1300 </paragraph>
                  <paragraph>
                     <content styleCode="bold">Tylan™ Soluble</content>
                     <br/>
                     <content styleCode="bold">™</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Tylosin Tartrate</content>
                  </paragraph>
                  <paragraph>Equivalent to <content styleCode="bold">100 g (3.53 oz)</content> tylosin base </paragraph>
                  <paragraph>
                     <content styleCode="bold">CAUTION:</content> Federal (USA) law restricts this drug to<br/>use by or on the order of a licensed veterinarian. </paragraph>
                  <paragraph>For oral use in chickens, turkeys, swine, and honey bees. </paragraph>
                  <paragraph>Macrolide Antibiotic<br/>Approved by FDA under NADA # 013-076</paragraph>
                  <paragraph>YL103717X</paragraph>
                  <renderMultiMedia ID="id-1470197577" referencedObject="ID_93f71648-57c5-4444-9768-dfc5a145ae14"/>
               </text>
               <effectiveTime value="20241217"/>
               <component>
                  <observationMedia ID="ID_93f71648-57c5-4444-9768-dfc5a145ae14">
                     <text>Principal Display Panel - Tylan Soluble Bottle Label</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="tyl06-0002-01.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>