<?xml version="1.0" encoding="UTF-8" standalone="no"?><?xml-stylesheet href="../../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="51352d7f-3c17-f0da-e063-6394a90a6be4"/>
  <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
  <title>Benadryl 
 <sup>®</sup> Allergy Liqui-Gels 
 <sup>®</sup>
  </title>
  <effectiveTime value="20260507"/>
  <setId root="bfeae100-e2d1-4607-be3b-2d9b15cd4f7f"/>
  <versionNumber value="10"/>
  <author>
    <time/>
    <assignedEntity>
      <representedOrganization>
        <id extension="118772437" root="1.3.6.1.4.1.519.1"/>
        <name>Kenvue Brands LLC</name>
        <assignedEntity>
          <assignedOrganization/>
        </assignedEntity>
      </representedOrganization>
    </assignedEntity>
  </author>
  <component>
    <structuredBody>
      <component>
        <section>
          <id root="51a0371f-cc56-a5c4-e063-6294a90a684f"/>
          <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
          <effectiveTime value="20260507"/>
          <subject>
            <manufacturedProduct>
              <manufacturedProduct>
                <code code="50580-228" codeSystem="2.16.840.1.113883.6.69"/>
                <name>Benadryl Allergy Liqui-Gels</name>
                <formCode code="C42954" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CAPSULE, LIQUID FILLED"/>
                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>diphenhydramine hydrochloride</name>
                  </genericMedicine>
                </asEntityWithGeneric>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="2G86QN327L" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>GELATIN, UNSPECIFIED</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="PDC6A3C0OX" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>GLYCERIN</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="3WJQ0SDW1A" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>POLYETHYLENE GLYCOL, UNSPECIFIED</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="059QF0KO0R" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>WATER</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="506T60A25R" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SORBITOL</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="mg" value="25"/>
                    <denominator unit="1" value="1"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="TC2D6JAD40" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>DIPHENHYDRAMINE HYDROCHLORIDE</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="8GTS82S83M" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>DIPHENHYDRAMINE</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <asContent>
                  <quantity>
                    <numerator unit="1" value="12"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code/>
                    <formCode code="C43168" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BLISTER PACK"/>
                    <asContent>
                      <quantity>
                        <numerator unit="1" value="2"/>
                        <denominator value="1"/>
                      </quantity>
                      <containerPackagedProduct>
                        <code code="50580-228-24" codeSystem="2.16.840.1.113883.6.69"/>
                        <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
                      </containerPackagedProduct>
                      <subjectOf>
                        <marketingAct>
                          <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                          <statusCode code="active"/>
                          <effectiveTime>
                            <low value="20090301"/>
                          </effectiveTime>
                        </marketingAct>
                      </subjectOf>
                    </asContent>
                  </containerPackagedProduct>
                  <subjectOf>
                    <characteristic>
                      <code code="SPLCMBPRDTP" codeSystem="2.16.840.1.113883.1.11.19255"/>
                      <value code="C112160" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Type 0: Not a Combination Product" xsi:type="CV"/>
                    </characteristic>
                  </subjectOf>
                </asContent>
                <asContent>
                  <quantity>
                    <numerator unit="1" value="6"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code/>
                    <formCode code="C43168" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BLISTER PACK"/>
                    <asContent>
                      <quantity>
                        <numerator unit="1" value="4"/>
                        <denominator value="1"/>
                      </quantity>
                      <containerPackagedProduct>
                        <code/>
                        <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
                        <asContent>
                          <quantity>
                            <numerator unit="1" value="2"/>
                            <denominator value="1"/>
                          </quantity>
                          <containerPackagedProduct>
                            <code code="50580-228-48" codeSystem="2.16.840.1.113883.6.69"/>
                            <formCode code="C43233" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="PACKAGE"/>
                          </containerPackagedProduct>
                          <subjectOf>
                            <marketingAct>
                              <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                              <statusCode code="active"/>
                              <effectiveTime>
                                <low value="20230201"/>
                              </effectiveTime>
                            </marketingAct>
                          </subjectOf>
                        </asContent>
                      </containerPackagedProduct>
                    </asContent>
                  </containerPackagedProduct>
                  <subjectOf>
                    <characteristic>
                      <code code="SPLCMBPRDTP" codeSystem="2.16.840.1.113883.1.11.19255"/>
                      <value code="C112160" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Type 0: Not a Combination Product" xsi:type="CV"/>
                    </characteristic>
                  </subjectOf>
                </asContent>
                <asContent>
                  <quantity>
                    <numerator unit="1" value="12"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code/>
                    <formCode code="C43168" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BLISTER PACK"/>
                    <asContent>
                      <quantity>
                        <numerator unit="1" value="4"/>
                        <denominator value="1"/>
                      </quantity>
                      <containerPackagedProduct>
                        <code/>
                        <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
                        <asContent>
                          <quantity>
                            <numerator unit="1" value="3"/>
                            <denominator value="1"/>
                          </quantity>
                          <containerPackagedProduct>
                            <code code="50580-228-49" codeSystem="2.16.840.1.113883.6.69"/>
                            <formCode code="C43233" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="PACKAGE"/>
                          </containerPackagedProduct>
                          <subjectOf>
                            <marketingAct>
                              <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                              <statusCode code="active"/>
                              <effectiveTime>
                                <low value="20230619"/>
                              </effectiveTime>
                            </marketingAct>
                          </subjectOf>
                        </asContent>
                      </containerPackagedProduct>
                    </asContent>
                  </containerPackagedProduct>
                  <subjectOf>
                    <characteristic>
                      <code code="SPLCMBPRDTP" codeSystem="2.16.840.1.113883.1.11.19255"/>
                      <value code="C112160" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Type 0: Not a Combination Product" xsi:type="CV"/>
                    </characteristic>
                  </subjectOf>
                </asContent>
              </manufacturedProduct>
              <subjectOf>
                <approval>
                  <id extension="M012" root="2.16.840.1.113883.3.9421"/>
                  <code code="C200263" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="OTC Monograph Drug"/>
                  <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="20090301"/>
                  </effectiveTime>
                </marketingAct>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <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>Clear</originalText>
                  </value>
                </characteristic>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLSCORE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value value="1" xsi:type="INT"/>
                </characteristic>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLSHAPE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value code="C48345" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="OVAL" xsi:type="CE">
                    <originalText/>
                  </value>
                </characteristic>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLSIZE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value unit="mm" value="15" xsi:type="PQ"/>
                </characteristic>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLIMPRINT" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value xsi:type="ST">BENADRYL</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 root="d0d4a2ef-0937-093d-e053-2995a90afe8a"/>
          <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="20161019"/>
        </section>
      </component>
      <component>
        <section>
          <id root="d0d4a2ef-0938-093d-e053-2995a90afe8a"/>
          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <title>Active ingredient (in each capsule)</title>
          <text>
            <paragraph>Diphenhydramine HCl 25 mg</paragraph>
          </text>
          <effectiveTime value="20161019"/>
        </section>
      </component>
      <component>
        <section>
          <id root="d0d4a2ef-0939-093d-e053-2995a90afe8a"/>
          <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="20161019"/>
        </section>
      </component>
      <component>
        <section>
          <id root="d0d4a2ef-093a-093d-e053-2995a90afe8a"/>
          <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="20161019"/>
        </section>
      </component>
      <component>
        <section>
          <id root="d0d4a2ef-093b-093d-e053-2995a90afe8a"/>
          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>Warnings</title>
          <effectiveTime value="20161019"/>
          <component>
            <section>
              <id root="d0d4a2ef-093c-093d-e053-2995a90afe8a"/>
              <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="20161019"/>
            </section>
          </component>
          <component>
            <section>
              <id root="d0d4a2ef-093d-093d-e053-2995a90afe8a"/>
              <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="20161019"/>
            </section>
          </component>
          <component>
            <section>
              <id root="d0d4a2ef-093e-093d-e053-2995a90afe8a"/>
              <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="20161019"/>
            </section>
          </component>
          <component>
            <section>
              <id root="d0d4a2ef-093f-093d-e053-2995a90afe8a"/>
              <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="20161019"/>
            </section>
          </component>
          <component>
            <section>
              <id root="d0d4a2ef-0940-093d-e053-2995a90afe8a"/>
              <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="20161019"/>
            </section>
          </component>
          <component>
            <section>
              <id root="d0d4a2ef-0941-093d-e053-2995a90afe8a"/>
              <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="20161019"/>
            </section>
          </component>
        </section>
      </component>
      <component>
        <section>
          <id root="d0d4a2ef-0942-093d-e053-2995a90afe8a"/>
          <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</item>
              <item>do not take more than 6 doses in 24 hours</item>
            </list>
            <table styleCode="Noautorules" width="100%">
              <col align="left" valign="top" width="40%"/>
              <col align="left" valign="top" width="60%"/>
              <tbody>
                <tr styleCode="Botrule">
                  <td styleCode="Toprule Rrule">  adults and children 12 years and over</td>
                  <td styleCode="Toprule">  1 to 2 capsules</td>
                </tr>
                <tr styleCode="Botrule">
                  <td styleCode="Rrule">  children 6 to under 12 years</td>
                  <td>  1 capsule</td>
                </tr>
                <tr>
                  <td styleCode="Rrule">  children under 6 years</td>
                  <td>  do not use this product in children under 6 years of age</td>
                </tr>
              </tbody>
            </table>
          </text>
          <effectiveTime value="20161019"/>
        </section>
      </component>
      <component>
        <section>
          <id root="d0d4a2ef-0943-093d-e053-2995a90afe8a"/>
          <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). Avoid high humidity and excessive heat. Protect from light.</item>
              <item>
                <content styleCode="bold">do not use if carton is open or blister unit is broken</content>
              </item>
            </list>
          </text>
          <effectiveTime value="20161019"/>
        </section>
      </component>
      <component>
        <section>
          <id root="d0d4a2ef-0944-093d-e053-2995a90afe8a"/>
          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title>Inactive ingredients</title>
          <text>
            <paragraph>gelatin, glycerin, polyethylene glycol, purified water, sorbitol. Capsules are imprinted with edible dye-free ink.</paragraph>
          </text>
          <effectiveTime value="20161019"/>
        </section>
      </component>
      <component>
        <section>
          <id root="d0d4a2ef-0945-093d-e053-2995a90afe8a"/>
          <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="20161019"/>
        </section>
      </component>
      <component>
        <section ID="id_link_efc52d36-4143-ff4b-e053-2a95a90ab2e5">
          <id root="efc52d36-4142-ff4b-e053-2a95a90ab2e5"/>
          <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 50580-228-24</paragraph>
            <paragraph>
              <content styleCode="bold">Benadryl</content>
              <sup>®</sup>
              <br/>
              <br/>
              <content styleCode="bold">
                <content styleCode="italics">ALLERGY
    <br/>
                  <br/>
LIQUI GELS 
    <sup>®*</sup>
                </content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Diphenhydramine HCl 25 mg | Antihistamine</content>
            </paragraph>
            <list listType="unordered">
              <item>Sneezing</item>
              <item>Runny Nose</item>
              <item>Itchy, Watery Eyes</item>
              <item>Itchy Throat</item>
            </list>
            <paragraph>
              <content styleCode="bold">DYE-FREE</content>
              <br/>
              <br/>
*liquid-filled capsules
 </paragraph>
            <paragraph>Actual Size</paragraph>
            <paragraph>
              <content styleCode="bold">24 CAPSULES</content>
            </paragraph>
            <paragraph>
              <renderMultiMedia referencedObject="MM1"/>
            </paragraph>
          </text>
          <effectiveTime value="20161019"/>
          <component>
            <observationMedia ID="MM1">
              <text>PRINCIPAL DISPLAY PANEL</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="benadryl-01.jpg"/>
              </value>
            </observationMedia>
          </component>
        </section>
      </component>
    </structuredBody>
  </component>
</document>