<?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">
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  <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
  <title>MiraLAX   <sup>®</sup>
  </title>
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    <time/>
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        <name>Cardinal Health 107, LLC</name>
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            <manufacturedProduct>
              <manufacturedProduct>
                <code code="55154-5035" codeSystem="2.16.840.1.113883.6.69"/>
                <name>MiraLAX</name>
                <formCode code="C42973" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="POWDER, FOR SOLUTION"/>
                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>Polyethylene Glycol 3350</name>
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                    <code code="G2M7P15E5P" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>POLYETHYLENE GLYCOL 3350</name>
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                        <code code="G2M7P15E5P" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>POLYETHYLENE GLYCOL 3350</name>
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                            <low value="20090223"/>
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                        <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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                    <originalText>Colorless upon dissolution</originalText>
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          <text>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">Drug Facts</content>
              </content>
            </paragraph>
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          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <title>Active ingredient (in each dose) (Bottle Only)</title>
          <text>
            <paragraph>Polyethylene Glycol 3350, 17 g (cap filled to line)</paragraph>
          </text>
          <effectiveTime value="20250228"/>
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          <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
          <title>Purpose</title>
          <text>
            <paragraph>Osmotic Laxative</paragraph>
          </text>
          <effectiveTime value="20250228"/>
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          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <title>Active ingredient (in each dose) (Packet Only)</title>
          <text>
            <paragraph>Polyethylene Glycol 3350, 17 g</paragraph>
          </text>
          <effectiveTime value="20241126"/>
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      </component>
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          <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
          <title>Purpose</title>
          <text>
            <paragraph>Osmotic Laxative</paragraph>
          </text>
          <effectiveTime value="20250228"/>
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          <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
          <title>Use</title>
          <text>
            <list listType="unordered">
              <item>
                <caption>•</caption>relieves occasional constipation (irregularity)</item>
              <item>
                <caption>•</caption>generally produces a bowel movement in 1 to 3 days</item>
            </list>
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          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>Warnings</title>
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              <title>Allergy alert</title>
              <text>
                <paragraph>Do not use if you are allergic to polyethylene glycol</paragraph>
              </text>
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              <code code="50570-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - DO NOT USE SECTION"/>
              <text>
                <paragraph>
                  <content styleCode="bold">Do not use </content>if you have kidney disease, except under the advice and supervision of a doctor            </paragraph>
              </text>
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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">
                  <item>
                    <caption>•</caption>nausea, vomiting or abdominal pain</item>
                  <item>
                    <caption>•</caption>a sudden change in bowel habits that lasts over 2 weeks</item>
                  <item>
                    <caption>•</caption>irritable bowel syndrome</item>
                </list>
              </text>
              <effectiveTime value="20241126"/>
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              <text>
                <paragraph>
                  <content styleCode="bold">Ask a doctor of pharmacist before use if you are </content>taking a prescription drug            </paragraph>
              </text>
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              <code code="50567-7" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - WHEN USING SECTION"/>
              <text>
                <paragraph>
                  <content styleCode="bold">When using this product </content>you may have loose, watery, more frequent stools            </paragraph>
              </text>
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              <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">
                  <item>
                    <caption>•</caption>you have rectal bleeding or you nausea, bloating or cramping or abdominal pain gets worse. These may be signs of a serious condition.</item>
                  <item>
                    <caption>•</caption>you get diarrhea</item>
                  <item>
                    <caption>•</caption>you need to use a laxative for longer than 1 week</item>
                </list>
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              <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>
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              <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 the reach of children. </content>In case of overdose, get medical help or contact a Poison Control Center right away.            </paragraph>
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          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <title>Directions (Bottle Only)</title>
          <text>
            <list listType="unordered">
              <item>
                <caption>•</caption>
                <content styleCode="bold">do not take more than directed unless advised by your doctor</content>
              </item>
              <item>
                <caption>•</caption>the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)</item>
              <item>
                <caption>•</caption>adults and children 17 years of age and older: 	    <list listType="unordered">
                  <item>
                    <caption>o</caption>use once a day</item>
                  <item>
                    <caption>o</caption>fill to top of white section in cap which is marked to indicate the correct dose (17 g)</item>
                  <item>
                    <caption>o</caption>stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink</item>
                  <item>
                    <caption>o</caption>do not combine with starch-based thickeners used for difficulty swallowing</item>
                  <item>
                    <caption>o</caption>ensure that the powder is fully dissolved before drinking</item>
                  <item>
                    <caption>o</caption>do not drink if there are any clumps</item>
                  <item>
                    <caption>o</caption>do not use no more than 7 days</item>
                </list>
              </item>
              <item>
                <caption>•</caption>children 16 years of age or under: ask a doctor</item>
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          <title>Directions (Packet Only)</title>
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            <list listType="unordered">
              <item>
                <caption>•</caption>
                <content styleCode="bold">do not take more than directed unless advised by your doctor</content>
              </item>
              <item>
                <caption>•</caption>adults and children 17 years of age and older: 	    <list listType="unordered">
                  <item>
                    <caption>o</caption>use once a day</item>
                  <item>
                    <caption>o</caption>stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink</item>
                  <item>
                    <caption>o</caption>do not combine with starch-based thickeners used for difficulty swallowing</item>
                  <item>
                    <caption>o</caption>ensure that the powder is fully dissolved before drinking</item>
                  <item>
                    <caption>o</caption>do not drink if there are any clumps</item>
                  <item>
                    <caption>o</caption>do not use more than 7 days</item>
                </list>
              </item>
              <item>
                <caption>•</caption>children 16 years of age or under: ask a doctor</item>
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          <title>Other information</title>
          <text>
            <list listType="unordered">
              <item>
                <caption>•</caption>store at 20°-25°C (68°-77°F)</item>
              <item>
                <caption>•</caption>tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken</item>
            </list>
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          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title>Inactive ingredients </title>
          <text>
            <paragraph>none</paragraph>
          </text>
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          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <title>Questions or comments?</title>
          <text>
            <paragraph>
              <content styleCode="bold">1-800-MiraLAX (1-800-647-2529)</content>
            </paragraph>
          </text>
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          <title>. </title>
          <text>
            <paragraph>Overbagged with 6 x 17g packets per bag, NDC 55154-5035-6</paragraph>
            <paragraph>WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.</paragraph>
            <paragraph>
              <content styleCode="bold">Distributed By:</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Cardinal Health </content>
            </paragraph>
            <paragraph>Dublin, OH 43017</paragraph>
            <paragraph>L4532222-11025 / L4532222-21025</paragraph>
          </text>
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          <title>Principal Display Panel </title>
          <text>
            <paragraph>NDC 55154-5035-6</paragraph>
            <paragraph>
              <content styleCode="bold">MiraLAX®</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Polyethylene Glycol 3350,</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Powder for Solution, Osmotic Laxative</content>
            </paragraph>
            <paragraph>6 PACKETS NET WT 0.5OZ (17g)</paragraph>
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              <text>bag label</text>
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