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                <content styleCode="italics">Active ingredient (in each tablet)</content>
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            <paragraph>Cetirizine hydrochloride USP 10 mg</paragraph>
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            <paragraph>Antihistamine</paragraph>
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            <paragraph>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:</paragraph>
            <list listType="unordered" styleCode="disc">
              <item>runny nose</item>
              <item>sneezing</item>
              <item>itchy, watery eyes</item>
              <item>itching of the nose or throat</item>
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          <title>Do not use</title>
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            <paragraph>if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.</paragraph>
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          <title>Ask a doctor before use if you have</title>
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            <paragraph>liver or kidney disease. Your doctor should determine if you need a different dose.</paragraph>
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          <title>Ask a doctor or pharmacist before use if you are</title>
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            <paragraph>taking tranquilizers or sedatives.</paragraph>
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          <title>When using this product</title>
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              <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>
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          <title>Stop use and ask a doctor if</title>
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            <paragraph>an allergic reaction to this product occurs. Seek medical help right away.</paragraph>
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          <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>
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          <title>Keep out of reach of children.</title>
          <text>
            <paragraph>In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)</paragraph>
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          <title>
            <content styleCode="italics">Directions</content>
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            <paragraph>Tablet melts in mouth. Can be taken with or without water.</paragraph>
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                  <td align="justify" styleCode="Lrule Rrule" valign="middle">adults and children 6 years and over<br/>
                  </td>
                  <td align="justify" styleCode="Rrule" valign="middle">one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.<br/>
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                <tr styleCode="Botrule">
                  <td align="justify" styleCode="Lrule Rrule" valign="middle">adults 65 years and over<br/>
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                  <td align="justify" styleCode="Rrule" valign="middle">ask a doctor<br/>
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                  <td align="justify" styleCode="Lrule Rrule" valign="middle">children under 6 years of age<br/>
                  </td>
                  <td align="justify" styleCode="Rrule" valign="middle">ask a doctor<br/>
                  </td>
                </tr>
                <tr>
                  <td align="justify" styleCode="Lrule Rrule" valign="middle">consumers with liver or kidney disease<br/>
                  </td>
                  <td align="justify" styleCode="Rrule" valign="middle">ask a doctor<br/>
                  </td>
                </tr>
              </tbody>
            </table>
          </text>
          <effectiveTime value="20250128"/>
        </section>
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      <component>
        <section ID="Section_13">
          <id root="cb5a93a0-279b-47ac-bb73-cc4a60805760"/>
          <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>
            <list listType="unordered" styleCode="disc">
              <item>store between 20° to 25°C (68° to 77°F). Avoid high humidity.</item>
              <item>
                <content styleCode="bold">do not use if blister unit is torn or broken</content>
              </item>
            </list>
          </text>
          <effectiveTime value="20250128"/>
        </section>
      </component>
      <component>
        <section ID="Section_28">
          <id root="1551344a-3438-4d27-96bf-23594918a7bd"/>
          <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>
            <paragraph>betadex, citric acid anhydrous, colloidal silicon dioxide, crospovidone, dl-alpha-tocopherol, hydroxypropyl cellulose, magnesium stearate, maize maltodextrin, mannitol, microcrystalline cellulose, natural flavourings, sodium bicarbonate, sodium starch glycolate and sucralose.<br/>
              <br/>
              <content styleCode="italics">
                <content styleCode="bold">Questions or comments? <br/>
                </content>
              </content>call<content styleCode="bold"> 1-855-274-4122 </content>(Monday - Friday 8:30 AM to 5:00 PM EST)</paragraph>
            <br/>
            <paragraph>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>
            <br/>
          </text>
          <effectiveTime value="20250128"/>
        </section>
      </component>
      <component>
        <section ID="Section_16">
          <id root="7cbdfc09-6754-494e-adc4-2aaf53d08e5f"/>
          <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
          <title>PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (12 Orally Disintegrating Tablets) Blister Carton</title>
          <text>
            <paragraph>
              <content styleCode="bold">AUROHEALTH<br/>
              </content>
              <content styleCode="bold">
                <br/> NDC 58602-838-75<br/>
              </content>
              <br/> *Compare to the active<br/> ingredient of Zyrtec<sup>®</sup> Allergy<br/>
              <br/>
              <content styleCode="bold">Original Prescription Strength<br/>
              </content>
              <content styleCode="bold">Cetirizine Hydrochloride<br/> Orally Disintegrating Tablets, USP 10 mg<br/>
              </content>
              <content styleCode="bold">Antihistamine<br/>
                <br/> Allergy<br/>
              </content>
              <content styleCode="bold">
                <content styleCode="italics">
                  <br/> DISSOLVE TABS<br/>
                </content>
                <br/> Indoor &amp; Outdoor Allergies<br/>
              </content>
              <content styleCode="bold">
                <br/> 24 Hour </content>Relief of:    <content styleCode="bold">    </content>Sneezing<br/>Runny Nose               Itchy, Watery        Itchy Throat<br/>                                          Eyes                   or Nose<br/>
              <content styleCode="bold">
                <br/> Dye-Free<br/>
                <br/> Melts in your mouth<br/> Orange Flavor<br/>
                <br/> Actual Size<br/>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">12 Orally <br/> Disintegrating<br/> Tablets<br/> 10 mg each<br/>
                <br/>
                <renderMultiMedia referencedObject="MM1"/>
              </content>
            </paragraph>
          </text>
          <effectiveTime value="20250128"/>
          <component>
            <observationMedia ID="MM1">
              <text>figure</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="cetirizine-fig1.jpg"/>
              </value>
            </observationMedia>
          </component>
        </section>
      </component>
    </structuredBody>
  </component>
</document>