<?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="01cd60eb-fe42-44ea-afc5-be8ed3f97d50"/>
   <code code="50577-6" codeSystem="2.16.840.1.113883.6.1" displayName="OTC ANIMAL DRUG LABEL"/>
   <title>PETARMOR® CAPACTION®<br/>(nitenpyram)</title>
   <effectiveTime value="20251118"/>
   <setId root="0433080f-fe44-499d-aac7-21267b2eb115"/>
   <versionNumber value="5"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id root="1.3.6.1.4.1.519.1" extension="876995171"/>
            <name>Sergeant's Pet Care Products LLC</name>
            <assignedEntity>
               <assignedOrganization>
                  <assignedEntity>
                     <assignedOrganization>
                        <id root="1.3.6.1.4.1.519.1" extension="480000413"/>
                        <name>DOTTIKON EXCLUSIVE SYNTHESIS AG</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
                           <code code="C82401" displayName="api manufacture" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        </actDefinition>
                     </performance>
                  </assignedEntity>
                  <assignedEntity>
                     <assignedOrganization>
                        <id root="1.3.6.1.4.1.519.1" extension="243313714"/>
                        <name>Vetio Animal Health ULC</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
                           <code code="C43360" displayName="manufacture" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        </actDefinition>
                     </performance>
                     <performance>
                        <actDefinition>
                           <code code="C25391" displayName="analysis" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        </actDefinition>
                     </performance>
                     <performance>
                        <actDefinition>
                           <code code="C84732" displayName="label" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        </actDefinition>
                     </performance>
                     <performance>
                        <actDefinition>
                           <code code="C84731" displayName="pack" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        </actDefinition>
                     </performance>
                  </assignedEntity>
               </assignedOrganization>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="ca69a611-8b7c-446b-9767-7345db012d52"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <title/>
               <text/>
               <effectiveTime value="20251118"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="21091-141" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>PETARMOR CAPACTION</name>
                        <formCode code="C42998" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TABLET"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Nitenpyram</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="11.4" unit="mg"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="3A837VZ81Y" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>NITENPYRAM</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="3A837VZ81Y" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>NITENPYRAM</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="EWQ57Q8I5X" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>LACTOSE MONOHYDRATE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="OP1R32D61U" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>CELLULOSE, MICROCRYSTALLINE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="O8232NY3SJ" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>STARCH, CORN</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="ETJ7Z6XBU4" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>SILICON DIOXIDE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="70097M6I30" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>MAGNESIUM STEARATE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="6" unit="1"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <formCode code="C43168" displayName="BLISTER PACK" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                              <asContent>
                                 <quantity>
                                    <numerator value="1" unit="1"/>
                                    <denominator value="1" unit="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="21091-141-01" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43182" displayName="CARTON" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                 </containerPackagedProduct>
                              </asContent>
                              <asContent>
                                 <quantity>
                                    <numerator value="1" unit="1"/>
                                    <denominator value="1" unit="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="21091-141-01" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43182" displayName="CARTON" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                    <asContent>
                                       <quantity>
                                          <numerator value="2" unit="1"/>
                                          <denominator value="1" unit="1"/>
                                       </quantity>
                                       <containerPackagedProduct>
                                          <code code="21091-141-05" codeSystem="2.16.840.1.113883.6.69"/>
                                          <formCode code="C43185" displayName="CELLO PACK" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                       </containerPackagedProduct>
                                    </asContent>
                                 </containerPackagedProduct>
                              </asContent>
                           </containerPackagedProduct>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20211012"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <subjectOf>
                        <approval>
                           <id extension="NADA141175" 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>
                        <characteristic>
                           <code code="SPLCOLOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value code="C48325" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="white" xsi:type="CE">
                              <originalText>to yellow</originalText>
                           </value>
                        </characteristic>
                     </subjectOf>
                     <subjectOf>
                        <characteristic>
                           <code code="SPLSHAPE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value code="C48348" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ROUND" xsi:type="CE">
                              <originalText>biconvex beveled edges</originalText>
                           </value>
                        </characteristic>
                     </subjectOf>
                     <subjectOf>
                        <characteristic>
                           <code code="SPLSIZE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value unit="mm" value="6" xsi:type="PQ"/>
                        </characteristic>
                     </subjectOf>
                     <subjectOf>
                        <characteristic>
                           <code code="SPLSCORE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value value="1" xsi:type="INT"/>
                        </characteristic>
                     </subjectOf>
                     <subjectOf>
                        <characteristic>
                           <code code="SPLIMPRINT" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value xsi:type="ST">RB;CG</value>
                        </characteristic>
                     </subjectOf>
                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/>
                        </substanceAdministration>
                     </consumedIn>
                  </manufacturedProduct>
               </subject>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="21091-142" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>PETARMOR CAPACTION</name>
                        <formCode code="C42998" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TABLET"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Nitenpyram</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="57.0" unit="mg"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="3A837VZ81Y" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>NITENPYRAM</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="3A837VZ81Y" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>NITENPYRAM</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="EWQ57Q8I5X" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>LACTOSE MONOHYDRATE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="OP1R32D61U" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>CELLULOSE, MICROCRYSTALLINE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="O8232NY3SJ" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>STARCH, CORN</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="ETJ7Z6XBU4" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>SILICON DIOXIDE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="70097M6I30" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>MAGNESIUM STEARATE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="6" unit="1"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <formCode code="C43168" displayName="BLISTER PACK" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                              <asContent>
                                 <quantity>
                                    <numerator value="1" unit="1"/>
                                    <denominator value="1" unit="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="21091-142-01" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43182" displayName="CARTON" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                 </containerPackagedProduct>
                              </asContent>
                              <asContent>
                                 <quantity>
                                    <numerator value="1" unit="1"/>
                                    <denominator value="1" unit="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="21091-142-01" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43182" displayName="CARTON" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                    <asContent>
                                       <quantity>
                                          <numerator value="2" unit="1"/>
                                          <denominator value="1" unit="1"/>
                                       </quantity>
                                       <containerPackagedProduct>
                                          <code code="21091-142-05" codeSystem="2.16.840.1.113883.6.69"/>
                                          <formCode code="C43185" displayName="CELLO PACK" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                       </containerPackagedProduct>
                                    </asContent>
                                 </containerPackagedProduct>
                              </asContent>
                           </containerPackagedProduct>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <approval>
                           <id extension="NADA141175" 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="20211012"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <subjectOf>
                        <characteristic>
                           <code code="SPLCOLOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value code="C48325" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="white" xsi:type="CE">
                              <originalText>to yellow</originalText>
                           </value>
                        </characteristic>
                     </subjectOf>
                     <subjectOf>
                        <characteristic>
                           <code code="SPLSHAPE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value code="C48348" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ROUND" xsi:type="CE">
                              <originalText>biconvex beveled edges</originalText>
                           </value>
                        </characteristic>
                     </subjectOf>
                     <subjectOf>
                        <characteristic>
                           <code code="SPLSIZE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value unit="mm" value="11" xsi:type="PQ"/>
                        </characteristic>
                     </subjectOf>
                     <subjectOf>
                        <characteristic>
                           <code code="SPLSCORE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value value="1" xsi:type="INT"/>
                        </characteristic>
                     </subjectOf>
                     <subjectOf>
                        <characteristic>
                           <code code="SPLIMPRINT" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value xsi:type="ST">HIH;CG</value>
                        </characteristic>
                     </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="Ldec19b7f-548a-4907-9e56-0d78240b1c4a">
               <id root="31e9de4a-d4ae-4141-8b85-546c8c05cefb"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>Capaction is an oral tablet for dogs, puppies, cats and kittens <content styleCode="bold">2 pounds of body weight or greater and 4 weeks of age and older</content>.</paragraph>
               </text>
               <effectiveTime value="20241212"/>
            </section>
         </component>
         <component>
            <section ID="La2adb69c-b5e4-44c8-bce6-9562a1c8ce35">
               <id root="43f0bb9e-eaa9-4f57-814b-0d33e0343bba"/>
               <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
               <title>ACTIVE INGREDIENTS</title>
               <text>
                  <paragraph>CAPACTION Tablets contain 11.4 or 57.0 mg of nitenpyram, which belongs to the chemical class of neonicotinoids. Nitenpyram kills adult fleas.</paragraph>
               </text>
               <effectiveTime value="20241212"/>
            </section>
         </component>
         <component>
            <section ID="La8edac49-eda7-4bbb-98f1-41131c0b5078">
               <id root="03bc53bc-e29b-4391-8d61-80d9a43521af"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>WARNINGS</title>
               <text>
                  <paragraph>Not for human use.  Keep this and all drugs out of the reach of children.</paragraph>
               </text>
               <effectiveTime value="20241212"/>
            </section>
         </component>
         <component>
            <section ID="L12dae699-a4b3-42d3-b615-603beecb9e15">
               <id root="817aaa93-cb03-4394-b778-1497a6f8d332"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>DIRECTIONS</title>
               <text>
                  <paragraph>CAPACTION Tablets kill adult fleas and are indicated for the treatment of flea infestations on dogs, puppies, cats and kittens <content styleCode="bold">2 pounds of body weight or greater and 4 weeks of age and older</content>.</paragraph>
                  <paragraph>A single dose of CAPACTION should kill the adult fleas on your pet. If your pet gets re-infested with fleas, you can safely give another dose as often as once per day.</paragraph>
                  <paragraph>To give CAPACTION Tablets, place the pill directly in your pet's mouth or hide it in food. If you hide the pill in food, watch closely to make sure your pet swallows the pill. If you are not sure that your pet swallowed the pill, it is safe to give a second pill.</paragraph>
                  <paragraph>Treat all infested pets in the household. Fleas can reproduce on untreated pets and allow infestations to persist.</paragraph>
                  <paragraph>
                     <content styleCode="bold">DOSAGE</content>
                     <br/>CAPACTION Tablets should be administered according to the following schedule.<content styleCode="bold"> Weigh your pet prior to administration to ensure proper dosage. Do not administer to pets under 2 pounds.</content>
                  </paragraph>
                  <table width="100%">
                     <caption>Recommended Dosage Schedule </caption>
                     <tbody>
                        <tr>
                           <td>
                              <content styleCode="bold"> Species</content>
                           </td>
                           <td>
                              <content styleCode="bold"> Body Weight</content>
                           </td>
                           <td>
                              <content styleCode="bold"> Dose</content>
                           </td>
                           <td>
                              <content styleCode="bold"> Nitenpyram Per Tablet</content>
                           </td>
                        </tr>
                        <tr>
                           <td> Dog or Cat</td>
                           <td> 2-25 lbs.</td>
                           <td> One Tablet</td>
                           <td> 11.4 mg</td>
                        </tr>
                        <tr>
                           <td> Dog</td>
                           <td> 25.1-125 lbs.</td>
                           <td> One Tablet</td>
                           <td> 57.0 mg</td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph/>
               </text>
               <effectiveTime value="20241212"/>
            </section>
         </component>
         <component>
            <section ID="L8ab11bf0-9b42-454b-8fa0-bf6df86e656d">
               <id root="bb40570f-1d33-4906-9800-966617dbb927"/>
               <code code="34084-4" codeSystem="2.16.840.1.113883.6.1" displayName="ADVERSE REACTIONS SECTION"/>
               <title>ADVERSE REACTIONS</title>
               <text>
                  <paragraph>Pre-approval laboratory and clinical studies showed that CAPACTION Tablets are safe for use in dogs and cats, puppies and kittens <content styleCode="bold">2 pounds of body weight or greater and 4 weeks of age and olde</content>
                     <content styleCode="bold">r. (See Post-Approval Experience section).</content>
                  </paragraph>
               </text>
               <effectiveTime value="20241212"/>
            </section>
         </component>
         <component>
            <section ID="La79bdc11-9456-4ed4-a968-4b2ca2fefeeb">
               <id root="ef18b05b-0ea3-45ff-b680-a23a24b023ee"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Post-Approval Experience (Rev. 2011):</title>
               <text>
                  <paragraph>The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse reactions are reported to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data. The following adverse events are listed in decreasing order of reporting frequency.</paragraph>
                  <paragraph>
                     <content styleCode="bold">CATS:</content> hyperactivity, panting, lethargy, itching, vocalization, vomiting, fever, decreased appetite, nervousness, diarrhea, difficulty breathing, salivation, incoordination, seizures, pupil dilation, increased heart rate, and trembling.</paragraph>
                  <paragraph>
                     <content styleCode="bold">DOGS:</content> lethargy/depression, vomiting, itching, decreased appetite, diarrhea, hyperactivity, incoordination, trembling, seizures, panting, allergic reactions including hives, vocalization, salivation, fever, and nervousness.</paragraph>
                  <paragraph>
                     <content styleCode="bold">The frequency of serious signs, including neurologic signs and death, was greater in animals under 2 pounds of body weight, less than 8 weeks of age, and/or reported to be in poor body condition. In some instances, birth defects and fetal/neonatal loss were reported after treatment of pregnant and/or lactating animals.</content>
                  </paragraph>
                  <paragraph>To report adverse effects, access medical information, or obtain additional product information call 1-800-781-4738. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or <content styleCode="underline">http://www.fda.gov/reportanimalae</content>.</paragraph>
                  <paragraph>For a complete listing of adverse reactions for nitenpyram reported to the CVM see: </paragraph>
                  <paragraph>
                     <content styleCode="underline">http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation</content>
                  </paragraph>
                  <paragraph/>
               </text>
               <effectiveTime value="20241212"/>
            </section>
         </component>
         <component>
            <section ID="Lbede913f-00c5-4fc0-956d-e79e69293960">
               <id root="e790ae85-380d-41a5-865b-4f750fbeb5cd"/>
               <code code="60561-8" codeSystem="2.16.840.1.113883.6.1" displayName="OTHER SAFETY INFORMATION"/>
               <title>OTHER INFORMATION</title>
               <text>
                  <paragraph>CAPACTION Tablets begin working within 30 minutes. In studies, CAPACTION achieved greater than 90% effectiveness against adult fleas on dogs within 4 hours and cats within 6 hours.</paragraph>
                  <paragraph>CAPACTION Tablets are safe for pregnant or nursing dogs and cats (See Post-Approval Experience section).</paragraph>
                  <paragraph>When using this product, you may notice that your dog or cat will start scratching itself as fleas begin to die. The scratching behavior is temporary and is a reaction to the fleas, not the drug. In cats and dogs, this may present as transient signs of hyperactivity, panting, vocalization and excessive grooming/licking.</paragraph>
                  <paragraph>CAPACTION Tablets kill adult fleas that cause flea allergy dermatitis (FAD).</paragraph>
                  <paragraph>CAPACTION Tablets may be used together with other products, including heartworm preventives, corticosteroids, antibiotics, vaccines, de-worming medications, shampoos and other flea products.</paragraph>
               </text>
               <effectiveTime value="20241212"/>
            </section>
         </component>
         <component>
            <section ID="L010e87ae-d0d6-4747-ac9a-2bc29aa2f895">
               <id root="11a03438-11c9-46b0-ac4f-0b84946a2fb7"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>FLEA INFESTATIONS ON DOGS AND CATS</title>
               <text>
                  <paragraph>In addition to the common nuisance irritations associated with infestations, fleas can be responsible for skin conditions in your pet such as flea allergy dermatitis (FAD) in the dog and miliary dermatitis in the cat. Also, fleas transmit other parasites, including tapeworms. The control of flea infestations is important to your pet's health and also reduces the problems associated with these parasites.</paragraph>
                  <paragraph>CAPACTION Tablets do not have an effect on fleas in the pet's environment. You may need to treat more than one time because immature fleas in and around the home will continue to develop into adults that can reinfest your pet.</paragraph>
                  <paragraph>The following diagram illustrates the flea's life cycle and where CAPACTION Tablets work:</paragraph>
               </text>
               <effectiveTime value="20241212"/>
            </section>
         </component>
         <component>
            <section ID="L8070c64b-5921-4f14-a68a-475c99a5e028">
               <id root="eca8ad4f-4319-4699-83bb-88f428c484b4"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>LIFE CYCLE OF FLEA</title>
               <text>
                  <paragraph>Fleas can be a problem because they reproduce so rapidly. A single female flea may produce up to 2,000 eggs over her lifetime. Eggs hatch and can develop into adults within only three weeks. Adult female fleas feed by ingesting blood from your pet and subsequently lay eggs, which drop off your pet's coat. Within days, larvae hatch from the eggs and live undetected in your pet's surroundings, such as the carpet, bedding and other protected areas. Flea larvae spin a cocoon, and, when appropriately stimulated, a young adult flea emerges and jumps onto your pet to continue the life cycle. When these new fleas are seen on your pet, treat with CAPACTION Tablets.</paragraph>
                  <paragraph>After reading this insert, if you have any questions about flea control or medical problems associated with flea infestations, consult your veterinarian, who is your pet's health care expert.</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="Lfa1b3550-8490-41f2-9f5e-65de904b4b42"/>
                  </paragraph>
                  <paragraph/>
               </text>
               <effectiveTime value="20241212"/>
               <component>
                  <observationMedia ID="Lfa1b3550-8490-41f2-9f5e-65de904b4b42">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="PetArmorCapAction_FleaCycle.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="L9029e11f-e838-42b2-b34f-1f48b251236b">
               <id root="29b7ec1e-47cf-461a-b1d4-9ff081f971a5"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>STORAGE CONDITIONS</title>
               <text>
                  <paragraph>Store at controlled room temperature, between 59° and 77°F (15°-25°C).</paragraph>
                  <paragraph>For questions, comments, <content>technical assistance or to report a suspected adverse event please call 1-800-781-4738</content>
                  </paragraph>
                  <paragraph>
                     <content>Approved by FDA under NADA # 141-175</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">PETIQ</content>
                  </paragraph>
               </text>
               <effectiveTime value="20230420"/>
            </section>
         </component>
         <component>
            <section ID="L3196f2e9-3f6a-4499-ad9b-a9af0a2dc61e">
               <id root="d7b4a9f1-1ee3-49b0-b892-4e907a313064"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>G002486 PetArmor Capaction Carton Dog 2-25 lbs. 6 ct</title>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="Lcc1201e8-3c64-44ee-bc68-337871167a4d"/>
                  </paragraph>
               </text>
               <effectiveTime value="20241211"/>
               <component>
                  <observationMedia ID="Lcc1201e8-3c64-44ee-bc68-337871167a4d">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="G002486_Capaction_SmDog_6ct.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="Lb8b710a7-7c15-4d97-99d9-1c45ccad68dc">
               <id root="c8511154-1941-4053-a2fe-2feaf2b589a9"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>G002488 PetArmor Capaction Carton Cat 2-25 lbs. 6 ct</title>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="Lb2c74e9a-5053-41a2-9880-9e1964950e6e"/>
                  </paragraph>
               </text>
               <effectiveTime value="20241211"/>
               <component>
                  <observationMedia ID="Lb2c74e9a-5053-41a2-9880-9e1964950e6e">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="G002488_Capaction_Cat_6ct.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="L4cadeb68-8943-4c2b-b333-2ca43c09d706">
               <id root="df79f75f-de58-4000-ba01-3f9104888dbb"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>G002487 PetArmor Capaction Carton Dog Over 25 lbs. 6 ct</title>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="L2c9d4f66-9169-4f7b-80e9-dfc5337097b8"/>
                  </paragraph>
               </text>
               <effectiveTime value="20241211"/>
               <component>
                  <observationMedia ID="L2c9d4f66-9169-4f7b-80e9-dfc5337097b8">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="G002487_Capaction_LgDog_6ct .jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>