<?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="4524d961-37c9-20b3-e063-6294a90a54d0"/>
  <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
  <title>MAJOR®
 <br/>
    <br/>
DOCUSATE
 <br/>
    <br/>
MINI ENEMA
 <br/>
    <br/>
30 Single Use
 <br/>
    <br/>
5 mL Disposable Tubes
 <br/>
    <br/>
Stool Softener Evacuant
</title>
  <effectiveTime value="20251204"/>
  <setId root="91099e15-94d7-b684-e053-2a95a90a574e"/>
  <versionNumber value="9"/>
  <author>
    <time/>
    <assignedEntity>
      <representedOrganization>
        <id extension="191427277" root="1.3.6.1.4.1.519.1"/>
        <name>Major Pharmaceuticals</name>
      </representedOrganization>
    </assignedEntity>
  </author>
  <component>
    <structuredBody>
      <component>
        <section>
          <id root="452451cb-c3ff-9107-e063-6294a90ad776"/>
          <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
          <effectiveTime value="20251204"/>
          <subject>
            <manufacturedProduct>
              <manufacturedProduct>
                <code code="0904-6920" codeSystem="2.16.840.1.113883.6.69"/>
                <name>Docusate Mini Enema</name>
                <formCode code="C42953" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="LIQUID"/>
                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>docusate sodium</name>
                  </genericMedicine>
                </asEntityWithGeneric>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="5655G9Y8AQ" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>POLYETHYLENE GLYCOL 300</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="ACTIB">
                  <quantity>
                    <numerator unit="mg" value="283"/>
                    <denominator unit="mL" value="5"/>
                  </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>
                <asContent>
                  <quantity>
                    <numerator unit="mL" value="5"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code/>
                    <formCode code="C42794" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TUBE"/>
                    <asContent>
                      <quantity>
                        <numerator unit="1" value="30"/>
                        <denominator value="1"/>
                      </quantity>
                      <containerPackagedProduct>
                        <code code="0904-6920-93" codeSystem="2.16.840.1.113883.6.69"/>
                        <formCode code="C43195" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="JAR"/>
                      </containerPackagedProduct>
                      <subjectOf>
                        <marketingAct>
                          <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                          <statusCode code="active"/>
                          <effectiveTime>
                            <low value="20190826"/>
                          </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="20190826"/>
                  </effectiveTime>
                </marketingAct>
              </subjectOf>
              <consumedIn>
                <substanceAdministration>
                  <routeCode code="C38295" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="RECTAL"/>
                </substanceAdministration>
              </consumedIn>
            </manufacturedProduct>
          </subject>
        </section>
      </component>
      <component>
        <section ID="Lf9a8a5e4-eb54-4850-848f-56e5d32d4224">
          <id root="b3c505cf-c794-d11f-e053-2a95a90a8b9d"/>
          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <title>
            <content styleCode="bold">Drug Facts</content>
          </title>
          <text>
            <paragraph>
              <content styleCode="bold">Active Ingredient (per delivered-dose)</content>
            </paragraph>
            <paragraph>Docusate Sodium USP 283 mg</paragraph>
          </text>
          <effectiveTime value="20190826"/>
        </section>
      </component>
      <component>
        <section ID="id_link_91abc00d-9acb-5ba7-e053-2995a90a22b5">
          <id root="b3c505cf-c795-d11f-e053-2a95a90a8b9d"/>
          <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
          <title>
            <content styleCode="bold">Purpose</content>
          </title>
          <text>
            <paragraph>Stool Softener Laxative</paragraph>
          </text>
          <effectiveTime value="20190826"/>
        </section>
      </component>
      <component>
        <section ID="L14bc8c36-05b7-43c1-85e1-bd8bccbe1b8a">
          <id root="b3c505cf-c796-d11f-e053-2a95a90a8b9d"/>
          <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>
            <list listType="unordered">
              <item>For relief of occasional constipation (irregularity).</item>
              <item>This product generally produces a bowel movement in 2 to 15 minutes.</item>
            </list>
          </text>
          <effectiveTime value="20190826"/>
        </section>
      </component>
      <component>
        <section ID="L9074b209-67a3-4653-81dd-e7be90a62272">
          <id root="b3c505cf-c797-d11f-e053-2a95a90a8b9d"/>
          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>
            <content styleCode="bold">Warnings</content>
          </title>
          <text>
            <paragraph>
              <content styleCode="bold">For rectal use only.</content> Drug Interaction Precaution: Do not take this product if you are presently taking mineral oil, unless directed by a doctor.
 
      

 </paragraph>
          </text>
          <effectiveTime value="20190826"/>
        </section>
      </component>
      <component>
        <section ID="Lf0ae52b9-18d4-4572-9be0-d2608acf5d2d">
          <id root="b3c505cf-c798-d11f-e053-2a95a90a8b9d"/>
          <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">
              <item>Laxative products when abdominal pain, nausea or vomiting are present.</item>
              <item>Laxative products for a period longer than 1 week unless directed by a doctor.</item>
            </list>
          </text>
          <effectiveTime value="20190826"/>
        </section>
      </component>
      <component>
        <section ID="Lbe2a1b2b-7b3b-437a-8195-8f7a0e6c0e6f">
          <id root="b3c505cf-c799-d11f-e053-2a95a90a8b9d"/>
          <code code="50568-5" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR/PHARMACIST SECTION"/>
          <title>
            <content styleCode="bold">Stop use and ask a doctor if you:</content>
          </title>
          <text>
            <list listType="unordered">
              <item>Rectal bleeding.</item>
              <item>Noticed a sudden change in bowel habits that persists over a period of 2 weeks.</item>
              <item>Failed to have a bowel movement after use. This may indicate a serious condition.</item>
            </list>
          </text>
          <effectiveTime value="20190826"/>
        </section>
      </component>
      <component>
        <section ID="L32172889-c011-4667-b029-cf71a85a775f">
          <id root="b3c505cf-c79a-d11f-e053-2a95a90a8b9d"/>
          <code code="53414-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PREGNANCY OR BREAST FEEDING SECTION"/>
          <title>
            <content styleCode="bold">Pregnant or Lactating Women</content>
          </title>
          <text>
            <paragraph>Ask a healthcare professional before use.</paragraph>
          </text>
          <effectiveTime value="20190826"/>
        </section>
      </component>
      <component>
        <section ID="Lb1dc51ae-395c-4cd6-87e9-991068fff59b">
          <id root="b3c505cf-c79b-d11f-e053-2a95a90a8b9d"/>
          <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 accidental ingestion, get medical help or contact a Poison Control Center immediately.</paragraph>
          </text>
          <effectiveTime value="20190826"/>
        </section>
      </component>
      <component>
        <section ID="L8cdf4100-984c-44c5-a2e2-89e5e92717a3">
          <id root="b3c505cf-c79c-d11f-e053-2a95a90a8b9d"/>
          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <title>
            <content styleCode="bold">Directions</content>
          </title>
          <text>
            <paragraph>Adults and children 12 years of age and older (with adult supervision) one to three units daily. Children under 12 years of age, consult a doctor prior to use.</paragraph>
            <list listType="unordered">
              <item>Twist off and remove tip.</item>
              <item>Lubricate tip prior to insertion: Place a few drops of the tube's liquid content on the shaft prior to insertion. Also apply liquid content or lubricant to the anus before inserting the mini-enema.</item>
              <item>Positioning: For best results, lay on the left side with knees bent. Insert slowley into rectum, up to shoulder of tube. Alternate Positions: Administer while seated on the toilet. Or, kneel, then lower head and chest forward until side of face is resting on the surface.</item>
              <item>With steady pressure, gently insert the tube into the rectum with care to prevent damage to the rectal wall. Squeeze to empty the contents. Keep the tube squeezed until it is removed from the rectum. After the contents have been emptied, remove the disposable tube and discard. A small amount of liquid may remain in the unit after use.</item>
            </list>
          </text>
          <effectiveTime value="20190826"/>
        </section>
      </component>
      <component>
        <section ID="Lffef3fb3-99dc-48fc-a1c6-8030d7e800ed">
          <id root="b3c505cf-c79d-d11f-e053-2a95a90a8b9d"/>
          <code code="60561-8" codeSystem="2.16.840.1.113883.6.1" displayName="OTHER SAFETY INFORMATION"/>
          <title>
            <content styleCode="bold">Other Information</content>
          </title>
          <text>
            <paragraph>
              <content styleCode="italics">
                <content styleCode="bold">Other Information</content>
              </content> Store at room temperature 15°-30° C (59°-86° F)
 
      

 </paragraph>
            <paragraph>RETAIN BOTTLE FOR COMPLETE DRUG FACTS</paragraph>
          </text>
          <effectiveTime value="20190826"/>
        </section>
      </component>
      <component>
        <section ID="L4616a7af-6f69-49e3-8d58-f3e7898c4516">
          <id root="b3c505cf-c79e-d11f-e053-2a95a90a8b9d"/>
          <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> Glycerin USP and Polyethylene Glycol</paragraph>
          </text>
          <effectiveTime value="20130828"/>
        </section>
      </component>
      <component>
        <section ID="L3a605c82-df1e-49e2-b8c2-42eee8e1d35b">
          <id root="b3c505cf-c79f-d11f-e053-2a95a90a8b9d"/>
          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <text>
            <paragraph>
              <content styleCode="italics">
                <content styleCode="bold">Questions or Comments:</content> (800) 616-2471
  
       
 
  </content>
            </paragraph>
          </text>
          <effectiveTime value="20190826"/>
        </section>
      </component>
      <component>
        <section ID="L716d7c19-449c-4059-84a3-52e4ab4e94e9">
          <id root="b3c505cf-c7a0-d11f-e053-2a95a90a8b9d"/>
          <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
          <text>
            <paragraph>
              <renderMultiMedia referencedObject="img_910c85f5-80f4-0f71-e053-2a95a90afbf8"/>
            </paragraph>
          </text>
          <effectiveTime value="20190826"/>
          <component>
            <observationMedia ID="img_910c85f5-80f4-0f71-e053-2a95a90afbf8">
              <text>pdp</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="MajorPDP.jpg"/>
              </value>
            </observationMedia>
          </component>
        </section>
      </component>
    </structuredBody>
  </component>
</document>