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   <code code="50577-6" codeSystem="2.16.840.1.113883.6.1" displayName="OTC ANIMAL DRUG LABEL"/>
   <title>
      <content styleCode="bold">Synanthic®</content>
      <br/>(oxfendazole oral suspension)<br/>
      <content styleCode="bold">Bovine Dewormer</content>
      <br/>
      <content styleCode="bold">Suspension, 22.5% </content>
   </title>
   <effectiveTime value="20250501"/>
   <setId root="152cde64-ff22-4a3e-bb78-65e159dbe6b6"/>
   <versionNumber value="12"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id extension="007134091" root="1.3.6.1.4.1.519.1"/>
            <name>Boehringer Ingelheim Animal Health USA Inc.</name>
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               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="0010-3832" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Synanthic Bovine Dewormer</name>
                        <formCode code="C42994" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="SUSPENSION"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>oxfendazole</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator unit="mg" value="225"/>
                              <denominator unit="mL" value="1"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="OMP2H17F9E" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>OXFENDAZOLE</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="OMP2H17F9E" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>OXFENDAZOLE</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
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                        <asContent>
                           <quantity>
                              <numerator unit="mL" value="500"/>
                              <denominator value="1"/>
                           </quantity>
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                              <code/>
                              <formCode code="C43173" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE, PLASTIC"/>
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                                    <code code="0010-3832-01" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
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                        <asContent>
                           <quantity>
                              <numerator unit="mL" value="1000"/>
                              <denominator value="1"/>
                           </quantity>
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                              <code/>
                              <formCode code="C43173" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE, PLASTIC"/>
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                                    <numerator unit="1" value="1"/>
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                                    <code code="0010-3832-02" codeSystem="2.16.840.1.113883.6.69"/>
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                                 </containerPackagedProduct>
                              </asContent>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator unit="mL" value="4000"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="0010-3832-03" codeSystem="2.16.840.1.113883.6.69"/>
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                           </containerPackagedProduct>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <approval>
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                           <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="20101221"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <consumedIn>
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               <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/>
               <text>
                  <paragraph>Each mL contains 225 mg of oxfendazole. </paragraph>
                  <paragraph>The entire contents of the 500 mL bottle treats 110 cattle weighing approximately 500 lbs each. </paragraph>
                  <paragraph>The entire contents of the 1000 mL bottle treats 220 cattle weighing approximately 500 lbs each.</paragraph>
                  <paragraph>Consult a veterinarian for assistance in the diagnosis, treatment and control of parasitism. </paragraph>
               </text>
               <effectiveTime value="20200729"/>
            </section>
         </component>
         <component>
            <section ID="i4i_veterinary_indications_id_814c6273-e2ff-4acf-85f0-56403b45110d">
               <id root="393ba6cb-0333-470e-a7a6-771b8fd0916d"/>
               <code code="50745-9" codeSystem="2.16.840.1.113883.6.1" displayName="VETERINARY INDICATIONS SECTION"/>
               <title>Indications:</title>
               <text>
                  <paragraph>SYNANTHIC Bovine Dewormer Suspension, 22.5%, is a broad-spectrum anthelmintic effective for the removal and control of the following parasites in cattle: lungworms, roundworms (including inhibited forms of <content styleCode="italics">Ostertagia  ostertagi</content>) and tapeworms, as indicated below: </paragraph>
                  <table width="100%">
                     <col width="25%"/>
                     <col width="44%"/>
                     <tbody>
                        <tr>
                           <td styleCode="Toprule " valign="top">
                              <paragraph>
                                 <content styleCode="bold">Lungworms:</content>
                              </paragraph>
                           </td>
                           <td styleCode="Toprule " valign="top">
                              <paragraph>
                                 <content styleCode="italics">Dictyocaulus viviparus</content> (Adult, L<sub>4</sub>)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top"/>
                           <td valign="top"/>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="bold">Stomach Worms:</content>
                              </paragraph>
                           </td>
                           <td valign="top"/>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>Barberpole Worms                 </paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">Haemonchus contortus</content> (Adult)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top"/>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">Haemonchus placei</content> (Adult)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>Small Stomach Worms</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">Trichostrongylus axei</content> (Adult)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>Brown Stomach Worms</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">Ostertagia ostertagi</content> (Adult, L<sub>4</sub>, inhibited L<sub>4</sub>)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="bold">Intestinal Worms:</content>
                              </paragraph>
                           </td>
                           <td valign="top"/>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>Nodular Worms</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">Oesophagostomum  radiatum</content> (Adult)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>Hookworms</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">Bunostomum phlebotomum</content> (Adult)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>Small Intestinal Worms</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">Cooperia punctata</content> (Adult, L<sub>4</sub>)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top"/>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">Cooperia oncophora</content> (Adult, L<sub>4</sub>)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top"/>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">Cooperia surnabada</content> (Adult, L<sub>4</sub>)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td valign="top">
                              <paragraph>Tapeworms</paragraph>
                           </td>
                           <td valign="top">
                              <paragraph>
                                 <content styleCode="italics">Moniezia benedeni</content> (Adult)</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule " valign="top"/>
                           <td styleCode="Botrule " valign="top"/>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph/>
               </text>
               <effectiveTime value="20200729"/>
            </section>
         </component>
         <component>
            <section ID="i4i_dosage_admin_id_6d2bd531-b506-4ad5-a348-1c794221a7dd">
               <id root="017da0bb-c4e3-4d91-95d8-9daa61afc136"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>Administration and Dosage:</title>
               <text>
                  <paragraph>SYNANTHIC Bovine Dewormer Suspension, 22.5%, is supplied in 500 mL and one liter packages containing 225 mg of oxfendazole per mL. The recommended dose for cattle is 2.05 mg/lb (4.5 mg/kg) of body weight. SYNANTHIC Bovine Dewormer Suspension, 22.5%, should be administered orally by accurate dose syringe at the rate of 1 mL per 110 lb (50 kg) of body weight. This product should be shaken well immediately prior to use. Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.</paragraph>
                  <paragraph>Remove Cap and Protective Seal and Replace with Draw Off Cap Prior to Use. Do Not Squeeze Sides of Bottle. Replace the Draw Off Cap with the Initial Cap after Use.</paragraph>
               </text>
               <effectiveTime value="20200729"/>
            </section>
         </component>
         <component>
            <section ID="i4i_dosage_admin_id_6096e9e8-8a90-4f23-9e59-7ff8355a8991">
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               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>Directions:</title>
               <text>
                  <paragraph>Determine the proper dose according to estimated body weight. Administer orally. The recommended dose of 2.05 mg/lb (4.5 mg/kg) is achieved when 1 mL of the suspension is given for each 110 lb (50 kg) of body weight. </paragraph>
                  <paragraph>
                     <content styleCode="bold">Examples:</content>
                  </paragraph>
                  <table width="100%">
                     <col width="18%"/>
                     <col width="15%"/>
                     <tbody>
                        <tr>
                           <td styleCode="Botrule Lrule Toprule " valign="top">
                              <paragraph>
                                 <content styleCode="bold">  Cattle Weight</content>
                              </paragraph>
                           </td>
                           <td styleCode="Rrule Botrule Lrule Toprule " valign="top">
                              <paragraph>
                                 <content styleCode="bold">  Dose</content>
                              </paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule Botrule " valign="top">
                              <paragraph>  110 lb   (50 kg)</paragraph>
                           </td>
                           <td styleCode="Rrule Lrule Botrule " valign="top">
                              <paragraph>  1.0 mL</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule Botrule " valign="top">
                              <paragraph>  220 lb (100 kg)</paragraph>
                           </td>
                           <td styleCode="Rrule Lrule Botrule " valign="top">
                              <paragraph>  2.0 mL</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule Botrule " valign="top">
                              <paragraph>  330 lb (150 kg)</paragraph>
                           </td>
                           <td styleCode="Rrule Lrule Botrule " valign="top">
                              <paragraph>  3.0 mL</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule Botrule " valign="top">
                              <paragraph>  440 lb (200 kg)</paragraph>
                           </td>
                           <td styleCode="Rrule Lrule Botrule " valign="top">
                              <paragraph>  4.0 mL</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule Botrule " valign="top">
                              <paragraph>  550 lb (250 kg)</paragraph>
                           </td>
                           <td styleCode="Rrule Lrule Botrule " valign="top">
                              <paragraph>  5.0 mL</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule Botrule " valign="top">
                              <paragraph>  660 lb (300 kg)</paragraph>
                           </td>
                           <td styleCode="Rrule Lrule Botrule " valign="top">
                              <paragraph>  6.0 mL</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule Botrule " valign="top">
                              <paragraph>  770 lb (350 kg)</paragraph>
                           </td>
                           <td styleCode="Rrule Lrule Botrule " valign="top">
                              <paragraph>  7.0 mL</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule Botrule " valign="top">
                              <paragraph>  880 lb (400 kg)</paragraph>
                           </td>
                           <td styleCode="Rrule Lrule Botrule " valign="top">
                              <paragraph>  8.0 mL</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule Botrule " valign="top">
                              <paragraph>  990 lb (450 kg)</paragraph>
                           </td>
                           <td styleCode="Rrule Lrule Botrule " valign="top">
                              <paragraph>  9.0 mL</paragraph>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Botrule Lrule " valign="top">
                              <paragraph>1100 lb (500 kg)</paragraph>
                           </td>
                           <td styleCode="Rrule Botrule Lrule " valign="top">
                              <paragraph>10.0 mL</paragraph>
                           </td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph>Treatment may be repeated in 4–6 weeks.</paragraph>
               </text>
               <effectiveTime value="20160909"/>
            </section>
         </component>
         <component>
            <section ID="i4i_residue_warning_id_f82b3538-215a-4387-8b8f-cbb2f41a34a4">
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               <code code="53412-3" codeSystem="2.16.840.1.113883.6.1" displayName="RESIDUE WARNING SECTION"/>
               <title>Residue Warnings:</title>
               <text>
                  <paragraph>Cattle must not be slaughtered until 7 days after treatment. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. </paragraph>
               </text>
               <effectiveTime value="20131114"/>
            </section>
         </component>
         <component>
            <section ID="ID_06ec1477-5947-4c23-951d-49bb2b16e764">
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               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>Other Warnings </title>
               <text>
                  <paragraph>Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers.</paragraph>
                  <paragraph>Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance.</paragraph>
                  <paragraph>Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd/flock, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method).</paragraph>
                  <paragraph>A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.</paragraph>
               </text>
               <effectiveTime value="20200729"/>
            </section>
         </component>
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               <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
               <title>Caution:</title>
               <text>
                  <paragraph>Use only as directed. Keep out of reach of children. Not for human use. </paragraph>
               </text>
               <effectiveTime value="20131114"/>
            </section>
         </component>
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            <section ID="i4i_contraindications_id_5220a23c-8670-4f55-bb8d-8af38c8ad964">
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               <code code="34070-3" codeSystem="2.16.840.1.113883.6.1" displayName="CONTRAINDICATIONS SECTION"/>
               <title>Safety:</title>
               <text>
                  <paragraph>There are no contraindications for the use of SYNANTHIC Bovine Dewormer Suspension, 22.5%, in cattle.</paragraph>
                  <paragraph>Shake well before use.</paragraph>
               </text>
               <effectiveTime value="20200729"/>
            </section>
         </component>
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               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>Storage:</title>
               <text>
                  <paragraph>Store at or below 25°C (77°F). Brief excursions are permitted up to 30°C (86°F). Do not freeze. </paragraph>
               </text>
               <effectiveTime value="20131114"/>
            </section>
         </component>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>Restricted Drug (California) – Use Only as Directed </paragraph>
                  <paragraph>© 2019 Boehringer Ingelheim Animal Health USA Inc. All rights reserved. </paragraph>
                  <paragraph>SYNANTHIC and the Cattle Head Logo are registered trademarks of Boehringer Ingelheim Animal Health USA Inc.</paragraph>
                  <paragraph>86993449</paragraph>
                  <paragraph>383208-02<br/>
                  </paragraph>
               </text>
               <effectiveTime value="20200729"/>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Marketed by:</content>
                     <br/>Boehringer Ingelheim Animal Health USA Inc.<br/>Duluth, GA 30096</paragraph>
               </text>
               <effectiveTime value="20200729"/>
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               <title>Principal Display Panel – Container Label 500 mL </title>
               <text>
                  <paragraph>NDC 0010-3832-01</paragraph>
                  <paragraph>
                     <content styleCode="bold">SYNANTHIC®</content>
                  </paragraph>
                  <paragraph>(oxfendazole oral suspension)</paragraph>
                  <paragraph>
                     <content styleCode="bold">Bovine Dewormer Suspension, 22.5%</content>
                  </paragraph>
                  <paragraph>For Animal Use Only</paragraph>
                  <paragraph>Net Contents: 500 mL</paragraph>
                  <paragraph>Approved by FDA under NADA # 140-854</paragraph>
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               <effectiveTime value="20200729"/>
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                  <observationMedia ID="F101F57B-BD11-4B74-99E5-639F83494B59">
                     <text>Picture of 500 mL label - left and center panel</text>
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                        <reference value="image-01.jpg"/>
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                     <text>Picture of 500 mL label - right panel</text>
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               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Principal Display Panel – Display Carton 500 mL </title>
               <text>
                  <paragraph>NDC 0010-3832-01</paragraph>
                  <paragraph>
                     <content styleCode="bold">SYNANTHIC®</content>
                  </paragraph>
                  <paragraph>(oxfendazole oral suspension)</paragraph>
                  <paragraph>
                     <content styleCode="bold">Bovine Dewormer Suspension, 22.5%</content>
                  </paragraph>
                  <paragraph>For Animal Use Only</paragraph>
                  <paragraph>
                     <content styleCode="bold">Net Contents: </content>500 mL</paragraph>
                  <paragraph>Approved by FDA under NADA # 140-854</paragraph>
                  <renderMultiMedia ID="id589826499" referencedObject="ID_4c4121ed-dc51-435f-adee-2c5219ee15da"/>
                  <renderMultiMedia ID="id-970364969" referencedObject="ID_90b33fe4-3e31-49f9-a7bd-87bd9883f3ac"/>
               </text>
               <effectiveTime value="20200729"/>
               <component>
                  <observationMedia ID="ID_4c4121ed-dc51-435f-adee-2c5219ee15da">
                     <text>Picture of 500 ml display carton - front and side panel</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="image-03.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="ID_90b33fe4-3e31-49f9-a7bd-87bd9883f3ac">
                     <text>Picture of 500 mL display carton - back and side panel</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="image-04.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
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