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                </characteristic>
              </subjectOf>
              <consumedIn>
                <substanceAdministration>
                  <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/>
                </substanceAdministration>
              </consumedIn>
            </manufacturedProduct>
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      <component>
        <section>
          <id root="c72a8f9c-7a1b-3240-e053-2a95a90ad907"/>
          <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
          <title/>
          <text>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">Drug Facts</content>
              </content>
            </paragraph>
          </text>
          <effectiveTime value="20200715"/>
        </section>
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      <component>
        <section>
          <id root="c72a8f9c-7a1c-3240-e053-2a95a90ad907"/>
          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <title>Active ingredient (in each tablet)</title>
          <text>
            <paragraph>Diphenhydramine HCl 25 mg</paragraph>
          </text>
          <effectiveTime value="20200715"/>
        </section>
      </component>
      <component>
        <section>
          <id root="c72a8f9c-7a1d-3240-e053-2a95a90ad907"/>
          <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
          <title>Purpose</title>
          <text>
            <paragraph>Antihistamine</paragraph>
          </text>
          <effectiveTime value="20200715"/>
        </section>
      </component>
      <component>
        <section>
          <id root="c72a8f9c-7a1e-3240-e053-2a95a90ad907"/>
          <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
          <title>Uses</title>
          <text>
            <list listType="unordered" styleCode="Square">
              <item>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
        
  
   <list listType="unordered" styleCode="Square">
                  <item>runny nose</item>
                  <item>sneezing</item>
                  <item>itchy, watery eyes</item>
                  <item>itching of the nose or throat</item>
                </list>
              </item>
              <item>temporarily relieves these symptoms due to the common cold:
        
  
   <list listType="unordered" styleCode="Square">
                  <item>runny nose</item>
                  <item>sneezing</item>
                </list>
              </item>
            </list>
          </text>
          <effectiveTime value="20200715"/>
        </section>
      </component>
      <component>
        <section>
          <id root="c72a8f9c-7a1f-3240-e053-2a95a90ad907"/>
          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>Warnings</title>
          <effectiveTime value="20200715"/>
          <component>
            <section>
              <id root="c72a8f9c-7a20-3240-e053-2a95a90ad907"/>
              <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="Square">
                  <item>to make a child sleepy</item>
                  <item>with any other product containing diphenhydramine, even one used on skin</item>
                </list>
              </text>
              <effectiveTime value="20200715"/>
            </section>
          </component>
          <component>
            <section>
              <id root="c72a8f9c-7a21-3240-e053-2a95a90ad907"/>
              <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="Square">
                  <item>a breathing problem such as emphysema or chronic bronchitis</item>
                  <item>glaucoma</item>
                  <item>trouble urinating due to an enlarged prostate gland</item>
                </list>
              </text>
              <effectiveTime value="20200715"/>
            </section>
          </component>
          <component>
            <section>
              <id root="c72a8f9c-7a22-3240-e053-2a95a90ad907"/>
              <code code="50568-5" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR/PHARMACIST SECTION"/>
              <text>
                <paragraph>
                  <content styleCode="bold">Ask a doctor or pharmacist before use if you are </content>taking sedatives or tranquilizers
        

 </paragraph>
              </text>
              <effectiveTime value="20200715"/>
            </section>
          </component>
          <component>
            <section>
              <id root="c72a8f9c-7a23-3240-e053-2a95a90ad907"/>
              <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="Square">
                  <item>marked 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>
                  <item>excitability may occur, especially in children</item>
                </list>
              </text>
              <effectiveTime value="20200715"/>
            </section>
          </component>
          <component>
            <section>
              <id root="c72a8f9c-7a24-3240-e053-2a95a90ad907"/>
              <code code="53414-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PREGNANCY OR BREAST FEEDING SECTION"/>
              <text>
                <paragraph>
                  <content styleCode="bold">If pregnant or breast-feeding, </content>ask a health professional before use.
        

 </paragraph>
              </text>
              <effectiveTime value="20200715"/>
            </section>
          </component>
          <component>
            <section>
              <id root="c72a8f9c-7a25-3240-e053-2a95a90ad907"/>
              <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
              <text>
                <paragraph>
                  <content styleCode="bold">Keep out of reach of children.</content> In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
        

 </paragraph>
              </text>
              <effectiveTime value="20200715"/>
            </section>
          </component>
        </section>
      </component>
      <component>
        <section>
          <id root="c72a8f9c-7a26-3240-e053-2a95a90ad907"/>
          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <title>Directions</title>
          <text>
            <list listType="unordered" styleCode="Square">
              <item>take every 4 to 6 hours, or as directed by a doctor</item>
              <item>do not take more than 6 times in 24 hours</item>
            </list>
            <table styleCode="Noautorules" width="75%">
              <col align="left" valign="top" width="50%"/>
              <col align="left" valign="top" width="50%"/>
              <tbody>
                <tr styleCode="Botrule">
                  <td styleCode="Rrule Toprule">adults and children 12 years and over</td>
                  <td styleCode="Toprule">1 to 2 tablets</td>
                </tr>
                <tr styleCode="Botrule">
                  <td styleCode="Rrule">children 6 to under 12 years</td>
                  <td>1 tablet</td>
                </tr>
                <tr>
                  <td styleCode="Rrule">children under 6 years</td>
                  <td>do not use</td>
                </tr>
              </tbody>
            </table>
          </text>
          <effectiveTime value="20200715"/>
        </section>
      </component>
      <component>
        <section ID="id_link_32e2d07f-7461-4eee-e063-6294a90a1812">
          <id root="32e2d07f-7460-4eee-e063-6294a90a1812"/>
          <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
          <title>Other information</title>
          <text>
            <list listType="unordered" styleCode="Square">
              <item>
                <content styleCode="bold">each tablet contains: </content>calcium 15 mg
  </item>
              <item>store between 20-25°C (68-77°F). Protect from light.</item>
              <item>
                <content styleCode="bold">do not use if blister unit is torn or broken</content>
              </item>
            </list>
          </text>
          <effectiveTime value="20200715"/>
        </section>
      </component>
      <component>
        <section>
          <id root="c72a8f9c-7a28-3240-e053-2a95a90ad907"/>
          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title>Inactive ingredients</title>
          <text>
            <paragraph>carnauba wax, croscarmellose sodium, D&amp;C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide</paragraph>
          </text>
          <effectiveTime value="20200715"/>
        </section>
      </component>
      <component>
        <section>
          <id root="c72a8f9c-7a29-3240-e053-2a95a90ad907"/>
          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <title>Questions or comments?</title>
          <text>
            <paragraph>call
       
 
  <content styleCode="bold"> 1-877-717-2824 </content>(toll-free) or
       
 
  <content styleCode="bold"> 215-273-8755 </content>(collect)
      

 </paragraph>
          </text>
          <effectiveTime value="20200715"/>
        </section>
      </component>
      <component>
        <section ID="id_link_0c4f5816-5598-1055-e063-6394a90a6744">
          <id root="32e2f02a-b2ff-3e86-e063-6394a90aa25b"/>
          <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
          <title>PRINCIPAL DISPLAY PANEL</title>
          <text>
            <paragraph>NDC 50580-226-12</paragraph>
            <paragraph>
              <content styleCode="bold">Benadryl 
   <sup>®</sup>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">ALLERGY</content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Diphenhydramine HCl 25mg | Antihistamine</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">✓ Sneezing
   <br/>
                <br/>
✓ Runny Nose
   <br/>
                <br/>
✓ Itchy, Watery Eyes
   <br/>
                <br/>
✓ Itchy Throat 
  </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">ULTRATABS 
   <sup>®*</sup>
              </content>
              <br/>
              <br/>
*small tablet size
 </paragraph>
            <paragraph>actual size</paragraph>
            <paragraph>
              <content styleCode="bold">12 TABLETS</content>
              <renderMultiMedia referencedObject="img_32e2e0bc-6e89-e773-e063-6294a90a7601"/>
              <content styleCode="bold"/>
            </paragraph>
            <paragraph/>
          </text>
          <effectiveTime value="20200715"/>
          <component>
            <observationMedia ID="img_32e2e0bc-6e89-e773-e063-6294a90a7601">
              <text>benadryl-01</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="benadryl-01.jpg"/>
              </value>
            </observationMedia>
          </component>
        </section>
      </component>
    </structuredBody>
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