<?xml version="1.0" encoding="UTF-8"?><?xml-stylesheet href="https://www.accessdata.fda.gov/spl/stylesheet/spl.xsl" type="text/xsl"?>
<document xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns="urn:hl7-org:v3" xsi:schemaLocation="urn:hl7-org:v3 https://www.accessdata.fda.gov/spl/schema/spl.xsd">
   <id root="297e4324-cd2d-6676-e063-6294a90a31fa"/>
   <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
   <title>CVS Health Stool Softener Clear</title>
   <effectiveTime value="20241217"/>
   <setId root="4d77facc-a01b-4b6d-8770-b0a429ec5bfd"/>
   <versionNumber value="6"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id root="1.3.6.1.4.1.519.1" extension="062312574"/>
            <name>CVS Pharmacy</name>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="297d826e-9ef9-5cfe-e063-6294a90ab28d"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <effectiveTime value="20241217"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="69842-633" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>CVS Health Stool Softener Clear</name>
                        <formCode code="C25158" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CAPSULE"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Docusate sodium</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="15FIX9V2JP" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>TITANIUM DIOXIDE</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="B697894SGQ" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>POLYETHYLENE GLYCOL 400</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="6DC9Q167V3" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>PROPYLENE GLYCOL</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="U725QWY32X" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>POVIDONE K30</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="100"/>
                              <denominator unit="1" value="1"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="F05Q2T2JA0" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>DOCUSATE SODIUM</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="M7P27195AG" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>DOCUSATE</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="2G86QN327L" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>GELATIN</name>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="60" unit="1"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code/>
                              <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
                              <asContent>
                                 <quantity>
                                    <numerator value="1" unit="1"/>
                                    <denominator value="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="69842-633-60" 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="20200211"/>
                                       </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="M007" 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="20200211"/>
                           </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>natural color</originalText>
                           </value>
                        </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="12" xsi:type="PQ"/>
                        </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="SPLIMPRINT" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value xsi:type="ST">100</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="L90492dca-3683-4dea-b074-b10e061a6571">
               <id root="9e546eb9-db31-f473-e053-2995a90a855f"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="italics">
                        <content styleCode="bold">Drug Facts</content>
                     </content>
                  </paragraph>
               </text>
               <effectiveTime value="20200211"/>
            </section>
         </component>
         <component>
            <section ID="L97c73584-a03c-4686-9a93-7400a3ccc676">
               <id root="9e546eb9-db32-f473-e053-2995a90a855f"/>
               <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
               <title>
                  <content styleCode="bold">Active ingredient</content>
                  <br/>
                  <content styleCode="bold">(in each softgel)</content>
               </title>
               <text>
                  <paragraph>Docusate sodium 100 mg</paragraph>
               </text>
               <effectiveTime value="20200211"/>
            </section>
         </component>
         <component>
            <section ID="Ldc1a7fdc-ee5f-4de2-87d7-2d76024378ab">
               <id root="9e546eb9-db33-f473-e053-2995a90a855f"/>
               <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
               <title>
                  <content styleCode="italics">
                     <content styleCode="bold">Purpose</content>
                  </content>
               </title>
               <text>
                  <paragraph>Stool softener</paragraph>
               </text>
               <effectiveTime value="20200211"/>
            </section>
         </component>
         <component>
            <section ID="Lc2b63830-e129-4fe7-bf1a-e2287f594f30">
               <id root="9e546eb9-db34-f473-e053-2995a90a855f"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>
                  <content styleCode="bold">Uses</content>
               </title>
               <text>
                  <paragraph>■ relieves occasional constipation (irregularity)
       
 
  
       
 
  <br/>■ generally produces bowel movement in 12 to 72 hours
      

 
      

 </paragraph>
               </text>
               <effectiveTime value="20200211"/>
            </section>
         </component>
         <component>
            <section ID="L8acc96b3-69d3-4c92-bb26-72b52090ee9b">
               <id root="9e546eb9-db35-f473-e053-2995a90a855f"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>
                  <content styleCode="italics">
                     <content styleCode="bold">Warnings</content>
                  </content>
               </title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Do not use</content>
                     <br/>■ if you are presently taking mineral oil, unless told to do
       
 
  
       
 
  <br/>so by a doctor
      

 
      

 </paragraph>
               </text>
               <effectiveTime value="20200211"/>
            </section>
         </component>
         <component>
            <section ID="L6497afd6-88a3-4b50-981e-f1d5efa69143">
               <id root="9e546eb9-db36-f473-e053-2995a90a855f"/>
               <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 before use if you have</content>
                     <br/>■ stomach pain ■ nausea ■ vomiting
       
 
  
       
 
  <br/>■ noticed a sudden change in bowel habits that lasts over
       
 
  
       
 
  <br/>2 weeks
      

 
      

 </paragraph>
               </text>
               <effectiveTime value="20200211"/>
            </section>
         </component>
         <component>
            <section ID="La255e891-28cc-49d4-98ca-5bf18d056936">
               <id root="9e546eb9-db37-f473-e053-2995a90a855f"/>
               <code code="50570-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - DO NOT USE SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Stop use and ask a doctor if</content>
                     <br/>■ you have rectal bleeding or fail to have a bowel
       
 
  
       
 
  <br/>movement after use of a laxative. These could be signs
       
 
  
       
 
  <br/>of a serious condition.
       
 
  
       
 
  <br/>■ you need to use a stool softener laxative for more than
       
 
  
       
 
  <br/>1 week
      

 
      

 </paragraph>
               </text>
               <effectiveTime value="20200211"/>
            </section>
         </component>
         <component>
            <section ID="Lec515c81-5544-4b40-bcd7-c1e30b754100">
               <id root="9e546eb9-db38-f473-e053-2995a90a855f"/>
               <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
       
 
  
       
 
  <br/>before use.
      

 
      

 </paragraph>
               </text>
               <effectiveTime value="20200211"/>
            </section>
         </component>
         <component>
            <section ID="L537db183-3656-475d-9b3e-457de7bb5d4f">
               <id root="9e546eb9-db39-f473-e053-2995a90a855f"/>
               <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
       
 
  
       
 
  <br/>medical help or contact a Poison Control Center right
       
 
  
       
 
  <br/>away. 1-800-222-1222
      

 
      

 </paragraph>
               </text>
               <effectiveTime value="20200211"/>
            </section>
         </component>
         <component>
            <section ID="Lebe0b6e7-efcc-459a-be4f-4872138b7e66">
               <id root="9e546eb9-db3a-f473-e053-2995a90a855f"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>
                  <content styleCode="italics">
                     <content styleCode="bold">Directions</content>
                  </content>
               </title>
               <text>
                  <paragraph>Take only by mouth. Doses may be taken as a single daily 
       
 
  <br/>dose or in divided doses.
      

 </paragraph>
                  <table width="100%">
                     <caption/>
                     <tbody>
                        <tr>
                           <td> adults and children 12 years 
          
    
     <br/>and over
         
   
    </td>
                           <td> take 1 to 3 softgels 
          
    
     <br/>daily
         
   
    </td>
                        </tr>
                        <tr>
                           <td> children 2 to under 12 years 
          
    
     <br/>of age
         
   
    </td>
                           <td> take 1  softgel
          
    
     <br/>daily
         
   
    </td>
                        </tr>
                        <tr>
                           <td> children under 2 years</td>
                           <td> ask a doctor</td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph/>
               </text>
               <effectiveTime value="20200211"/>
            </section>
         </component>
         <component>
            <section ID="Laf5930f3-52e6-4bfe-9e01-2f866137205f">
               <id root="9e546eb9-db3b-f473-e053-2995a90a855f"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>
                  <content styleCode="italics">
                     <content styleCode="bold">Other information</content>
                  </content>
               </title>
               <text>
                  <paragraph>■ 
       
 
  <content styleCode="bold">each softgel contains:</content> sodium 5 mg  
       
 
  <br/>
                     <br/>■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). 
      

 </paragraph>
                  <paragraph>■ Keep tightly closed</paragraph>
               </text>
               <effectiveTime value="20200211"/>
            </section>
         </component>
         <component>
            <section ID="L1c8c893c-3ec5-49c2-a823-daaa31e28994">
               <id root="9e546eb9-db3c-f473-e053-2995a90a855f"/>
               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <title>
                  <content styleCode="bold">Inactive ingredients</content>
               </title>
               <text>
                  <paragraph>gelatin, glycerin, polyethylene glycol-400, povidone (PVP K-30), propylene glycol, purified water, sorbitol solution, titanium dioxide</paragraph>
               </text>
               <effectiveTime value="20200211"/>
            </section>
         </component>
         <component>
            <section ID="L8e48cf60-1cf3-4896-beca-17965d3de91b">
               <id root="9e546eb9-db3d-f473-e053-2995a90a855f"/>
               <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Questions or comments? 1-888-333-9792</content>
                  </paragraph>
               </text>
               <effectiveTime value="20200211"/>
            </section>
         </component>
         <component>
            <section ID="L408e928c-b0ca-4483-85ab-f2a558e154a4">
               <id root="9e546eb9-db3e-f473-e053-2995a90a855f"/>
               <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>CVS Health</paragraph>
                  <paragraph>Compare to the
       
 
  <br/>active ingredient
       
 
  <br/>in Colace®*
      

 </paragraph>
                  <paragraph>Stool
       
 
  <br/>Softener
       
 
  <br/>DOCUSATE SODIUM, 100 mg
       
 
  <br/>•Relieves constipation
      

 </paragraph>
                  <list listType="unordered">
                     <item>Stimulant free</item>
                     <item>Gentle &amp; effective</item>
                  </list>
                  <paragraph>DYE
       
 
  <br/>FREE
      

 </paragraph>
                  <paragraph>60 SOFTGELS</paragraph>
                  <paragraph/>
                  <paragraph>*This product is not manufactured or
       
 
  <br/>distributed by Purdue Products L.P., owner
       
 
  <br/>of the registered trademark Colace®.
      

 </paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="Lb7973e5d-0e90-4d75-b538-c3b17ff7d81f"/>
                  </paragraph>
               </text>
               <effectiveTime value="20200211"/>
               <component>
                  <observationMedia ID="Lb7973e5d-0e90-4d75-b538-c3b17ff7d81f">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Colace Clear.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>