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                <name>Childrens Cetirizine Hydrochloride Hives Relief<suffix/>
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                    <originalText>Colorless to Pale Yellow</originalText>
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                    <originalText>Cherry Mint</originalText>
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        <section ID="Section_1">
          <id root="305f7024-03b3-4f50-9921-9ada2e3904a9"/>
          <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
          <title>
            <content styleCode="italics">Drug Facts</content>
          </title>
          <effectiveTime value="20251209"/>
          <component>
            <section ID="Section_1.1">
              <id root="efe1688e-eff5-48f2-a965-7247f5b4f641"/>
              <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
              <title>
                <content styleCode="italics">Active ingredient (in each 5 mL)</content>
              </title>
              <text>
                <br/>
                <paragraph>Cetirizine hydrochloride USP 5 mg</paragraph>
              </text>
              <effectiveTime value="20251209"/>
            </section>
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              <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
              <title>
                <content styleCode="italics">Purpose</content>
              </title>
              <text>
                <br/>
                <paragraph>Antihistamine</paragraph>
              </text>
              <effectiveTime value="20251209"/>
            </section>
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          <title>
            <content styleCode="italics">Uses</content>
          </title>
          <text>
            <paragraph>reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.</paragraph>
            <br/>
          </text>
          <effectiveTime value="20251209"/>
        </section>
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          <title>
            <content styleCode="italics">Warnings</content>
          </title>
          <text>
            <br/>
            <paragraph>
              <content styleCode="bold">Severe Allergy Warning:</content>
              <br/>
              <br/>Get emergency help <content styleCode="bold">immediately </content>if you have hives along with any of the following symptoms: </paragraph>
            <br/>
            <list listType="unordered" styleCode="disc">
              <item>trouble swallowing </item>
              <item>dizziness or loss of consciousness</item>
              <item>swelling of tongue</item>
              <item>swelling in or around mouth</item>
              <item>trouble speaking</item>
              <item>drooling</item>
              <item>wheezing or problems breathing</item>
            </list>
            <br/>
            <paragraph>These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional <content styleCode="bold">immediately</content>. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.<br/>
              <content styleCode="bold">
                <br/> Not a Substitute for Epinephrine</content>. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.</paragraph>
          </text>
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              <id root="30e48237-a016-415a-8b9b-bea886bbfcac"/>
              <code code="50570-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - DO NOT USE SECTION"/>
              <title>Do not use</title>
              <text>
                <list listType="unordered" styleCode="disc">
                  <item>to <content styleCode="bold">prevent</content> hives from any known cause such as:  <list listType="unordered" styleCode="disc">
                      <item>foods                   </item>
                      <item>insect stings </item>
                      <item>medicines                </item>
                      <item>latex or rubber gloves</item>
                    </list>
                  </item>
                </list>
                <br/>
                <paragraph>because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.  </paragraph>
                <br/>
                <list listType="unordered" styleCode="disc">
                  <item>If you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.</item>
                </list>
              </text>
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          <component>
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              <code code="50569-3" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR SECTION"/>
              <title>Ask a doctor before use if you have</title>
              <text>
                <list listType="unordered" styleCode="disc">
                  <item>liver or kidney disease. Your doctor should determine if you need a different dose.</item>
                  <item>hives that are an unusual color, look bruised or blistered</item>
                  <item>hives that do not itch</item>
                </list>
              </text>
              <effectiveTime value="20251209"/>
            </section>
          </component>
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              <code code="50568-5" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR/PHARMACIST SECTION"/>
              <title>Ask a doctor or pharmacist before use if you are</title>
              <text>
                <br/>
                <paragraph>taking tranquilizers or sedatives.</paragraph>
              </text>
              <effectiveTime value="20251209"/>
            </section>
          </component>
          <component>
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              <code code="50567-7" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - WHEN USING SECTION"/>
              <title>When using this product</title>
              <text>
                <list listType="unordered" styleCode="disc">
                  <item>drowsiness may occur </item>
                  <item>avoid alcoholic drinks</item>
                  <item>alcohol, sedatives, and tranquilizers may increase drowsiness</item>
                  <item>be careful when driving a motor vehicle or operating machinery</item>
                </list>
              </text>
              <effectiveTime value="20251209"/>
            </section>
          </component>
          <component>
            <section ID="Section_3.5">
              <id root="545d0c6f-5be4-4ef6-89e6-c0a975e759e8"/>
              <code code="50566-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - STOP USE SECTION"/>
              <title>Stop use and ask a doctor if</title>
              <text>
                <list listType="unordered" styleCode="disc">
                  <item>an allergic reaction to this product occurs. Seek medical help right away. </item>
                  <item>symptoms do not improve after 3 days of treatment</item>
                  <item>the hives have lasted more than 6 weeks</item>
                </list>
              </text>
              <effectiveTime value="20251209"/>
            </section>
          </component>
          <component>
            <section ID="Section_3.6">
              <id root="630864b8-de54-4ad3-b07a-2f1dfc9973b1"/>
              <code code="53414-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PREGNANCY OR BREAST FEEDING SECTION"/>
              <title>If pregnant or breast-feeding:</title>
              <text>
                <list listType="unordered" styleCode="disc">
                  <item>If breast-feeding: not recommended</item>
                  <item>if pregnant: ask a health professional before use.</item>
                </list>
              </text>
              <effectiveTime value="20251209"/>
            </section>
          </component>
          <component>
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              <id root="10170bb0-af68-4bef-8206-cacde8789ff1"/>
              <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
              <title>Keep out of reach of children.</title>
              <text>
                <br/>
                <paragraph>In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)</paragraph>
              </text>
              <effectiveTime value="20251209"/>
            </section>
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        </section>
      </component>
      <component>
        <section ID="Section_4">
          <id root="a5789a10-b7da-440d-afa3-fd6015252909"/>
          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="Dosage &amp; Administration Section"/>
          <title>
            <content styleCode="italics">Directions</content>
          </title>
          <text>
            <br/>
            <list listType="unordered" styleCode="disc">
              <item>use only with enclosed dosing cup</item>
              <item>find right dose on chart below</item>
              <item>mL = milliliter</item>
            </list>
            <br/>
            <table border="0" cellpadding="0" cellspacing="0" width="574.56">
              <colgroup>
                <col width="50.6944444444444%"/>
                <col width="49.3055555555556%"/>
              </colgroup>
              <tbody>
                <tr styleCode="Botrule">
                  <td styleCode="Lrule Rrule" valign="top">adults and children 6 years and over<br/>
                  </td>
                  <td styleCode="Rrule" valign="top"> 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.<br/>
                  </td>
                </tr>
                <tr styleCode="Botrule">
                  <td styleCode="Lrule Rrule" valign="top">adults 65 years and over<br/>
                  </td>
                  <td styleCode="Rrule" valign="top"> 5 mL once daily; do not take more than 5 mL in 24 hours.<br/>
                  </td>
                </tr>
                <tr styleCode="Botrule">
                  <td styleCode="Lrule Rrule" valign="top">children under 6 years of age<br/>
                  </td>
                  <td styleCode="Rrule" valign="top">ask a doctor<br/>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Lrule Rrule" valign="top">consumers with liver or kidney disease   <br/>
                  </td>
                  <td styleCode="Rrule" valign="top">ask a doctor<br/>
                  </td>
                </tr>
              </tbody>
            </table>
          </text>
          <effectiveTime value="20251209"/>
        </section>
      </component>
      <component>
        <section ID="Section_5">
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          <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
          <title>
            <content styleCode="italics">Other information</content>
          </title>
          <text>
            <br/>
            <list listType="unordered" styleCode="disc">
              <item>store between 20° to 25°C (68° to 77°F)</item>
              <item>
                <content styleCode="bold">Do not use if carton is opened, or if cap safety seal is broken or missing.</content>
              </item>
            </list>
          </text>
          <effectiveTime value="20251209"/>
        </section>
      </component>
      <component>
        <section ID="Section_6">
          <id root="55ce4a49-a3fe-4290-8c1f-612c3523b6b8"/>
          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title>
            <content styleCode="italics">Inactive ingredients</content>
          </title>
          <text>
            <br/>
            <paragraph>cherry mint flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate trihydrate, sucrose</paragraph>
          </text>
          <effectiveTime value="20251209"/>
        </section>
      </component>
      <component>
        <section ID="Section_7">
          <id root="e39ecdd6-367b-42cc-8414-4fff6af3e0fb"/>
          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <title>
            <content styleCode="italics">Questions?</content>
          </title>
          <text>
            <br/>
            <paragraph>call <content styleCode="bold">1-855-274-4122<br/>
              </content>(Monday – Friday 8:30 AM to 5:00 PM EST)<br/>
              <br/> Distributed by:<br/>
              <content styleCode="bold">AUROHEALTH LLC</content>
              <br/>279 Princeton-Hightstown Road<br/> East Windsor, NJ 08520<br/>
              <br/> Made in India</paragraph>
          </text>
          <effectiveTime value="20251209"/>
        </section>
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      <component>
        <section ID="Section_8">
          <id root="57e5ceb9-ac1f-487a-b678-8852841ff71c"/>
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          <title>PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL (120 mL Bottle)</title>
          <text>
            <content styleCode="bold"/>
            <br/>
            <paragraph>
              <content styleCode="bold"> AUROHEALTH<br/>
                <br/> NDC 58602-030-24<br/>
                <br/>
              </content>
              <content styleCode="bold">
                <content styleCode="italics">Children's<br/>
                </content>Cetirizine Hydrochloride <br/> Oral Solution USP 1 mg/mL<br/> antihistamine<br/>
                <br/>
                <content styleCode="italics">HIVES</content> <content styleCode="italics">RELIEF<br/>
                  <br/>
                </content>
              </content>
              <content styleCode="bold">24</content>
              <br/>
              <content styleCode="bold">Hour r</content>
              <content styleCode="bold">elief      Reduces Itching          Reduces<br/>                          Due to Hives               Hives<br/>
              </content>
              <content styleCode="bold">6 yrs &amp;<br/> older<content styleCode="italics">
                  <br/>
                  <br/>
                </content>4 fl oz (120 mL)<br/>
                <br/> Cherry </content>
              <content styleCode="bold">Flavor<br/>
              </content>
            </paragraph>
            <br/>
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          <effectiveTime value="20251209"/>
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              <text>PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL (120 mL Bottle)</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="cetirizine-hives-fig1.jpg"/>
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      <component>
        <section ID="Section_9">
          <id root="ab468d92-a415-48b8-9f1d-75a583a939a4"/>
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          <title>PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL Carton (120 mL)</title>
          <text>
            <br/>
            <paragraph>
              <content styleCode="bold">AUROHEALTH<br/>
                <br/> NDC 58602-030-24<br/>
              </content>
              <br/>
              <content styleCode="bold">*Compare to the active ingredient<br/> in Children's ZYRTEC<sup>®</sup>
                <br/>
                <br/>
              </content>
              <content styleCode="bold">
                <content styleCode="italics">Children's<br/>
                </content>Cetirizine Hydrochloride <br/> Oral Solution USP <br/> 1 mg/mL<br/> antihistamine<br/>
                <br/>
              </content>
              <content styleCode="bold">Hives</content>
              <br/>
              <content styleCode="bold"> Relief</content>
              <br/>
              <content styleCode="bold">6 yrs &amp;<br/> older<br/>
                <br/>
              </content>
              <content styleCode="bold">
                <content styleCode="italics">HIVES</content> <content styleCode="italics">RELIEF</content>
              </content>
            </paragraph>
            <br/>
            <br/>
            <content styleCode="bold">
              <content styleCode="italics"/>
            </content>
            <paragraph>
              <content styleCode="bold"> 24 Hour relief<br/>
              </content>
              <content styleCode="bold">Reduces Itching          Reduces<br/>
              </content>
              <content styleCode="bold">Due to Hives                Hives<br/>
                <br/>
              </content>
              <content styleCode="bold">Cherry </content>
              <content styleCode="bold">Flavor<br/>
                <br/>
              </content>
              <content styleCode="bold">4 fl oz (120 mL)<br/>
                <br/>
              </content>Dosing cup<br/> included</paragraph>
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            <br/>
            <br/>
            <br/>
            <br/>
          </text>
          <effectiveTime value="20251209"/>
          <component>
            <observationMedia ID="MM2">
              <text>PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL Carton (120 mL)</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="cetirizine-hives-fig2.jpg"/>
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