<?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="744b643a-d15c-4a5b-b28e-c8714126cda7"/>
  <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
  <title>Rite Aid 44-329</title>
  <effectiveTime value="20240108"/>
  <setId root="e1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd"/>
  <versionNumber value="5"/>
  <author>
    <assignedEntity>
      <representedOrganization>
        <id extension="830016429" root="1.3.6.1.4.1.519.1"/>
        <name>A-S Medication Solutions</name>
        <assignedEntity>
          <assignedOrganization>
            <assignedEntity>
              <assignedOrganization>
                <id extension="830016429" root="1.3.6.1.4.1.519.1"/>
                <name>A-S Medication Solutions</name>
              </assignedOrganization>
              <performance>
                <actDefinition>
                  <code code="C73607" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="RELABEL"/>
                  <product>
                    <manufacturedProduct classCode="MANU">
                      <manufacturedMaterialKind>
                        <code code="50090-5546" codeSystem="2.16.840.1.113883.6.69"/>
                      </manufacturedMaterialKind>
                    </manufacturedProduct>
                  </product>
                </actDefinition>
              </performance>
            </assignedEntity>
          </assignedOrganization>
        </assignedEntity>
      </representedOrganization>
    </assignedEntity>
  </author>
  <component>
    <structuredBody>
      <component>
        <section>
          <id root="8a7cb22a-0ec5-4e03-beb2-8b10cd9d230d"/>
          <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL listing data elements section"/>
          <effectiveTime value="20231207"/>
          <subject>
            <manufacturedProduct>
              <manufacturedProduct>
                <code code="50090-5546" codeSystem="2.16.840.1.113883.6.69"/>
                <name>Banophen</name>
                <formCode code="C42931" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TABLET, FILM COATED"/>
                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>Diphenhydramine HCl</name>
                  </genericMedicine>
                </asEntityWithGeneric>
                <asEquivalentEntity classCode="EQUIV">
                  <code code="C64637" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                  <definingMaterialKind>
                    <code code="0904-5551" codeSystem="2.16.840.1.113883.6.69"/>
                  </definingMaterialKind>
                </asEquivalentEntity>
                <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>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="O8232NY3SJ" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>STARCH, CORN</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="ZK64F7XSTX" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>D&amp;C RED NO. 27 ALUMINUM LAKE</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="O7TSZ97GEP" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>DIBASIC CALCIUM PHOSPHATE DIHYDRATE</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="70097M6I30" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>MAGNESIUM STEARATE</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="OP1R32D61U" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>MICROCRYSTALLINE CELLULOSE</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="532B59J990" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>POLYVINYL ALCOHOL, UNSPECIFIED</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="ETJ7Z6XBU4" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SILICON DIOXIDE</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="4ELV7Z65AP" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>STEARIC ACID</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="7SEV7J4R1U" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>TALC</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="15FIX9V2JP" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>TITANIUM DIOXIDE</name>
                  </ingredientSubstance>
                </ingredient>
                <asContent>
                  <quantity>
                    <numerator unit="1" value="12"/>
                    <denominator unit="1" value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <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="50090-5546-0" 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="20210517"/>
                          </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>
              </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="19900302"/>
                  </effectiveTime>
                </marketingAct>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLCOLOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value code="C48328" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="pink" xsi:type="CV"/>
                </characteristic>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLIMPRINT" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value xsi:type="ST">44;329</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="CV"/>
                </characteristic>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLSIZE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value unit="mm" value="11" xsi:type="PQ"/>
                </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="LINK_89831331-b620-4d27-946a-6a5f4df7c126">
          <id root="75678a4d-feda-4aa5-900f-630d0d852d82"/>
          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <title>
            <content styleCode="bold">
              <content styleCode="italics">Active ingredient (in each tablet)</content>
            </content>
          </title>
          <text>
            <paragraph>Diphenhydramine HCl 25 mg</paragraph>
          </text>
          <effectiveTime value="20231207"/>
        </section>
      </component>
      <component>
        <section ID="LINK_56f002b8-5bf0-48f9-99ed-5a0d851d4315">
          <id root="67e82c9b-caec-4e7a-bd37-1aeb44b6016d"/>
          <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
          <title>
            <content styleCode="bold">
              <content styleCode="italics">Purpose</content>
            </content>
          </title>
          <text>
            <paragraph>Antihistamine</paragraph>
          </text>
          <effectiveTime value="20231207"/>
        </section>
      </component>
      <component>
        <section ID="LINK_568e9735-4aac-48b0-9b01-2de56c14bdeb">
          <id root="a3304d7c-9e9a-489f-ae4b-432f8b77f452"/>
          <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
          <title>
            <content styleCode="bold">
              <content styleCode="italics">Uses</content>
            </content>
          </title>
          <text>
            <list listType="unordered" styleCode="Disk">
              <item>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:<list listType="unordered" styleCode="Square">
                  <item>runny nose</item>
                  <item>itchy, watery eyes</item>
                  <item>sneezing</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="20231207"/>
        </section>
      </component>
      <component>
        <section ID="LINK_e67b6128-6778-4547-bb9e-d43ce4f02d70">
          <id root="2c19340d-cdeb-459c-bb15-16864d9d98b1"/>
          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>
            <content styleCode="bold">
              <content styleCode="italics">Warnings</content>
            </content>
          </title>
          <text>
            <br/>
          </text>
          <effectiveTime value="20231207"/>
          <component>
            <section ID="LINK_cc207bf8-85de-4f80-9c4a-dcc446f7cda2">
              <id root="03b4c2fc-3c08-4583-b6ab-a2fc7c336cd4"/>
              <code code="50570-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - DO NOT USE SECTION"/>
              <title>
                <content styleCode="bold">Do not use</content>
              </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 <br/>
                  </item>
                </list>
              </text>
              <effectiveTime value="20231207"/>
            </section>
          </component>
          <component>
            <section ID="LINK_6ed70292-ad85-4956-9366-740b264b9189">
              <id root="801162ff-c4d9-4f67-ba44-1d6e1cb5967b"/>
              <code code="50569-3" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR SECTION"/>
              <title>
                <content styleCode="bold">Ask a doctor before use if you have</content>
              </title>
              <text>
                <list listType="unordered" styleCode="Square">
                  <item>a breathing problem such as emphysema or chronic bronchitis</item>
                  <item>glaucoma</item>
                  <item>difficulty in urination due to enlargement of the prostate gland<br/>
                  </item>
                </list>
              </text>
              <effectiveTime value="20231207"/>
            </section>
          </component>
          <component>
            <section ID="LINK_0f294904-da8d-4428-bbe1-8c7d374ac83a">
              <id root="efce8fa3-2b83-419c-969f-e63c6c51753d"/>
              <code code="50568-5" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR/PHARMACIST SECTION"/>
              <title>
                <content styleCode="bold">Ask a doctor or pharmacist before use if you are</content>
              </title>
              <text>
                <paragraph>taking sedatives or tranquilizers.</paragraph>
              </text>
              <effectiveTime value="20231207"/>
            </section>
          </component>
          <component>
            <section ID="LINK_9998793a-3e9d-42fc-9087-72504ce31296">
              <id root="abc2bc5e-5aa8-49a7-a4de-087ce64ec03f"/>
              <code code="50567-7" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - WHEN USING SECTION"/>
              <title>
                <content styleCode="bold">When using this product</content>
              </title>
              <text>
                <list listType="unordered" styleCode="Square">
                  <item>marked drowsiness may occur</item>
                  <item>avoid alcoholic beverages<br/>
                  </item>
                  <item>alcohol, sedatives, and tranquilizers may increase drowsiness</item>
                  <item>use caution when driving a motor vehicle or operating machinery</item>
                  <item>excitability may occur, especially in children </item>
                </list>
              </text>
              <effectiveTime value="20231207"/>
            </section>
          </component>
          <component>
            <section ID="LINK_e70967f2-8d0b-4272-b3c7-3a7ff3d4084b">
              <id root="47d7aff5-db16-4fb7-9cc4-b8590b5d9ace"/>
              <code code="53414-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PREGNANCY OR BREAST FEEDING SECTION"/>
              <title>
                <content styleCode="bold">If pregnant or breast-feeding,</content>
              </title>
              <text>
                <paragraph>ask a health professional before use.</paragraph>
              </text>
              <effectiveTime value="20231207"/>
            </section>
          </component>
          <component>
            <section ID="LINK_522d45a4-7316-47af-9de3-cc834163965e">
              <id root="4ee5ee97-242b-498a-916f-c863409b0ab8"/>
              <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
              <title>
                <content styleCode="bold">Keep out of reach of children.</content>
              </title>
              <text>
                <paragraph>In case of overdose, get medical help or contact a Poison Control Center right away.</paragraph>
              </text>
              <effectiveTime value="20231207"/>
            </section>
          </component>
        </section>
      </component>
      <component>
        <section ID="LINK_abdea946-e5fb-4d92-9e9d-55f1a4e0770a">
          <id root="354f30a6-ee88-4d35-bf8b-3f017dd5dd30"/>
          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <title>
            <content styleCode="bold">
              <content styleCode="italics">Directions</content>
            </content>
          </title>
          <text>
            <list listType="unordered" styleCode="Square">
              <item>
                <content styleCode="bold">do not take more than directed</content>
                <br/>
              </item>
              <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 cellpadding="0" cellspacing="0">
              <col/>
              <col width="1px"/>
              <tbody>
                <tr>
                  <td styleCode=" Botrule Rrule">adults and children 12 <br/>years and over</td>
                  <td styleCode=" Botrule">1 to 2 tablets<br/>
                  </td>
                </tr>
                <tr>
                  <td styleCode=" Botrule Rrule">children 6 to under 12 <br/>years</td>
                  <td styleCode=" Botrule">1 tablet<br/>
                  </td>
                </tr>
                <tr>
                  <td styleCode=" Rrule">children under 6 years </td>
                  <td>do not use</td>
                </tr>
              </tbody>
            </table>
          </text>
          <effectiveTime value="20231207"/>
        </section>
      </component>
      <component>
        <section ID="LINK_07229a3a-db9b-438c-a709-5aaf08bf737e">
          <id root="57c76992-1cc1-4746-ae9a-95fb414bd1b7"/>
          <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
          <title>
            <content styleCode="bold">
              <content styleCode="italics">Other information</content>
            </content>
          </title>
          <text>
            <list listType="unordered" styleCode="Square">
              <item>
                <content styleCode="bold">each tablet contains: </content>calcium 30 mg</item>
              <item>
                <content styleCode="bold">TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN<br/>
                </content>
              </item>
              <item>store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)</item>
              <item>protect from moisture</item>
              <item>see end flap for expiration date and lot number</item>
            </list>
          </text>
          <effectiveTime value="20231207"/>
        </section>
      </component>
      <component>
        <section ID="LINK_66ac58f7-706d-4d21-b12f-c71f63fa00c4">
          <id root="b8ed4bc2-245c-49c0-b680-ed262f3286fe"/>
          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title>
            <content styleCode="bold">
              <content styleCode="italics">Inactive ingredients</content>
            </content>
          </title>
          <text>
            <paragraph>corn starch, D&amp;C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide</paragraph>
          </text>
          <effectiveTime value="20231207"/>
        </section>
      </component>
      <component>
        <section ID="LINK_52621729-dfb5-4266-9021-65e5d5872e34">
          <id root="1b9ef3a9-db49-45cd-a379-979df215e822"/>
          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <title>
            <content styleCode="italics">
              <content styleCode="bold">Questions or comments?</content>
            </content>
          </title>
          <text>
            <paragraph>
              <content styleCode="bold">(800)-616-2471</content>
              <br/>
            </paragraph>
          </text>
          <effectiveTime value="20231207"/>
        </section>
      </component>
      <component>
        <section>
          <id root="73bfd5b8-13bf-485f-a353-b52acbbeafaf"/>
          <code code="34069-5" codeSystem="2.16.840.1.113883.6.1" displayName="HOW SUPPLIED SECTION"/>
          <title>HOW SUPPLIED</title>
          <text>
            <paragraph>Product:    50090-5546</paragraph>
            <paragraph>NDC:    50090-5546-0   12 TABLET, FILM COATED in a BLISTER PACK   /  2  in a  CARTON </paragraph>
          </text>
          <effectiveTime value="20240108"/>
        </section>
      </component>
      <component>
        <section>
          <id root="ae997707-c086-49e9-ae52-5a613c260142"/>
          <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
          <title>BANOPHEN (DIPHENHYDRAMINE HCL) TABLET</title>
          <text>
            <renderMultiMedia referencedObject="lbl500905546"/>
          </text>
          <effectiveTime value="20240108"/>
          <component>
            <observationMedia ID="lbl500905546">
              <text>Label Image</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="lbl500905546.jpg"/>
              </value>
            </observationMedia>
          </component>
        </section>
      </component>
    </structuredBody>
  </component>
</document>