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  <title>Benadryl Allergy Plus Congestion</title>
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                <name>Benadryl Allergy Plus Congestion</name>
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                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride</name>
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                    <name>TITANIUM DIOXIDE</name>
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                    <numerator unit="mg" value="25"/>
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                            <low value="20170619"/>
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                        <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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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">
                <content styleCode="italics">Drug Facts</content>
              </content>
            </paragraph>
          </text>
          <effectiveTime value="20200813"/>
        </section>
      </component>
      <component>
        <section>
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          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <effectiveTime value="20200813"/>
          <component>
            <section>
              <id root="dc8d740a-a893-1d06-e053-2a95a90aa6c5"/>
              <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
              <text>
                <table width="65%">
                  <col align="left" valign="top" width="60%"/>
                  <col align="right" valign="top" width="40%"/>
                  <thead>
                    <tr>
                      <th>
                        <content styleCode="italics">Active ingredients (in each tablet)</content>
                      </th>
                      <th>
                        <content styleCode="italics">Purposes</content>
                      </th>
                    </tr>
                  </thead>
                  <tbody>
                    <tr>
                      <td>Diphenhydramine HCl 25 mg</td>
                      <td>Antihistamine</td>
                    </tr>
                    <tr>
                      <td>Phenylephrine HCl 10 mg</td>
                      <td>Nasal decongestant</td>
                    </tr>
                  </tbody>
                </table>
              </text>
              <effectiveTime value="20200813"/>
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          <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>
                  <item>nasal congestion</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>
                  <item>nasal congestion</item>
                </list>
              </item>
              <item>temporarily relieves sinus congestion and pressure</item>
            </list>
          </text>
          <effectiveTime value="20200813"/>
        </section>
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          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>Warnings</title>
          <effectiveTime value="20200813"/>
          <component>
            <section>
              <id root="dc8d740a-a896-1d06-e053-2a95a90aa6c5"/>
              <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>
                  <item>if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.</item>
                </list>
              </text>
              <effectiveTime value="20200813"/>
            </section>
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          <component>
            <section>
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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="Square">
                  <item>heart disease</item>
                  <item>high blood pressure</item>
                  <item>thyroid disease</item>
                  <item>diabetes</item>
                  <item>trouble urinating due to an enlarged prostate gland</item>
                  <item>a breathing problem such as emphysema or chronic bronchitis</item>
                  <item>glaucoma</item>
                </list>
              </text>
              <effectiveTime value="20200813"/>
            </section>
          </component>
          <component>
            <section>
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              <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="20200813"/>
            </section>
          </component>
          <component>
            <section>
              <id root="dc8d740a-a899-1d06-e053-2a95a90aa6c5"/>
              <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>
                    <content styleCode="bold">do not exceed recommended dose</content>
                  </item>
                  <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="20200813"/>
            </section>
          </component>
          <component>
            <section>
              <id root="dc8d740a-a89a-1d06-e053-2a95a90aa6c5"/>
              <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="Square">
                  <item>nervousness, dizziness, or sleeplessness occur</item>
                  <item>symptoms do not improve within 7 days or occur with a fever</item>
                </list>
              </text>
              <effectiveTime value="20200813"/>
            </section>
          </component>
          <component>
            <section>
              <id root="dc8d740a-a89b-1d06-e053-2a95a90aa6c5"/>
              <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="20200813"/>
            </section>
          </component>
          <component>
            <section>
              <id root="dc8d740a-a89c-1d06-e053-2a95a90aa6c5"/>
              <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>
                </paragraph>
                <paragraph>In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)</paragraph>
              </text>
              <effectiveTime value="20200813"/>
            </section>
          </component>
        </section>
      </component>
      <component>
        <section>
          <id root="dc8d740a-a89d-1d06-e053-2a95a90aa6c5"/>
          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <title>Directions</title>
          <text>
            <table styleCode="Noautorules" width="60%">
              <col align="left" valign="top" width="30%"/>
              <col align="left" valign="top" width="70%"/>
              <tbody>
                <tr styleCode="Botrule">
                  <td styleCode="Rrule Toprule">adults and children 12 years and over</td>
                  <td styleCode="Toprule">
                    <list listType="unordered" styleCode="Square">
                      <item>take 1 tablet every 4 hours</item>
                      <item>do not take more than 6 tablets in 24 hours</item>
                    </list>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule">children under 12 years</td>
                  <td>ask a doctor</td>
                </tr>
              </tbody>
            </table>
          </text>
          <effectiveTime value="20200813"/>
        </section>
      </component>
      <component>
        <section>
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          <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>store between 20-25°C (68-77°F).</item>
              <item>
                <content styleCode="bold">do not use if carton is opened or if blister unit is broken</content>
              </item>
            </list>
          </text>
          <effectiveTime value="20200813"/>
        </section>
      </component>
      <component>
        <section>
          <id root="dc8d740a-a89f-1d06-e053-2a95a90aa6c5"/>
          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title>Inactive ingredients</title>
          <text>
            <paragraph>carnauba wax, FD&amp;C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polyvinyl alcohol, powdered cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide</paragraph>
          </text>
          <effectiveTime value="20200813"/>
        </section>
      </component>
      <component>
        <section>
          <id root="dc8d740a-a8a0-1d06-e053-2a95a90aa6c5"/>
          <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">1-888-217-2117</content> (toll-free) or 
       
 
  <content styleCode="bold">215-273-8755</content> (collect)
      

 </paragraph>
          </text>
          <effectiveTime value="20200813"/>
        </section>
      </component>
      <component>
        <section>
          <id root="dc8d740a-a8a1-1d06-e053-2a95a90aa6c5"/>
          <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 50580-415-01</paragraph>
            <paragraph>
              <content styleCode="bold">Benadryl
        
  
   <sup>®</sup>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">ALLERGY PLUS
        
   
    <br/>CONGESTION
       
  
   </content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Diphenhydramine HCl 25mg | Antihistamine
        
  
   <br/>Phenylephrine HCl 10mg | Nasal Decongestant
       
 
  </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">✓ Sneezing
        
  
   <br/>✓ Runny Nose
        
  
   <br/>✓ Sinus Congestion
        
  
   <br/>✓ Itchy, Watery Eyes
        
  
   <br/>✓ Itchy Throat
        
  
   <br/>✓ Sinus Pressure
       
 
  </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">ULTRATABS
        
  
   <sup>®</sup>*
       
 
  </content>
              <br/>*small tablet size
      

 </paragraph>
            <paragraph>actual size</paragraph>
            <paragraph>
              <content styleCode="bold">24 TABLETS</content>
            </paragraph>
            <renderMultiMedia referencedObject="MM1"/>
          </text>
          <effectiveTime value="20200813"/>
          <component>
            <observationMedia ID="MM1">
              <text>Principal Display Panel</text>
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                <reference value="benadryl-01.jpg"/>
              </value>
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          </component>
        </section>
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