<?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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  <title>MiraLAX 
 <sup>® </sup>Orange Flavor
</title>
  <effectiveTime value="20251204"/>
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  <author>
    <time/>
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        <name>Bayer HealthCare LLC.</name>
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            <manufacturedProduct>
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                <name>MiraLAX Orange Flavor</name>
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                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>Polyethylene Glycol 3350</name>
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                <ingredient classCode="IACT">
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                    <code code="96K6UQ3ZD4" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SUCRALOSE</name>
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                    <numerator unit="g" value="17"/>
                    <denominator unit="g" value="17"/>
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                  <ingredientSubstance>
                    <code code="G2M7P15E5P" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>POLYETHYLENE GLYCOL 3350</name>
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                        <name>POLYETHYLENE GLYCOL 3350</name>
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                    <numerator unit="g" value="119"/>
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                    <numerator unit="g" value="238"/>
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                        <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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                    <originalText>White or almost white solid with a waxy or paraffin-like appearance</originalText>
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          <text>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">Drug Facts</content>
              </content>
            </paragraph>
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          <effectiveTime value="20230915"/>
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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)</title>
          <text>
            <paragraph>Polyethylene Glycol 3350, 17 g (cap filled to line)</paragraph>
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          <effectiveTime value="20230915"/>
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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="20230915"/>
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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>relieves occasional constipation (irregularity)</item>
              <item>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>
          <effectiveTime value="20230915"/>
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              <title>Allergy alert</title>
              <text>
                <paragraph>Do not use if you are allergic to polyethylene glycol</paragraph>
              </text>
              <effectiveTime value="20140411"/>
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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>
              <effectiveTime value="20140411"/>
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            <section>
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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>nausea, vomiting or abdominal pain</item>
                  <item>a sudden change in bowel habits that lasts over 2 weeks</item>
                  <item>irritable bowel syndrome</item>
                </list>
              </text>
              <effectiveTime value="20140411"/>
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          <component>
            <section>
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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>
              <effectiveTime value="20140411"/>
            </section>
          </component>
          <component>
            <section>
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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>
              <effectiveTime value="20140411"/>
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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>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>you get diarrhea</item>
                  <item>you need to use a laxative for longer than 1 week</item>
                </list>
              </text>
              <effectiveTime value="20140411"/>
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          <component>
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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>
              <effectiveTime value="20140411"/>
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              <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(1-800-222-1222).
 </paragraph>
              </text>
              <effectiveTime value="20230915"/>
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          <title>Directions (Bottle Only)</title>
          <text>
            <list listType="unordered">
              <item>
                <content styleCode="bold">do not take more than directed unless advised by your doctor</content>
              </item>
              <item>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>adults and children 17 years of age and older:
	
   <list listType="unordered">
                  <item>use once a day</item>
                  <item>fill to top of white section in cap which is marked to indicate the correct dose (17 g)</item>
                  <item>stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink</item>
                  <item>do not combine with starch-based thickeners used for difficulty swallowing</item>
                  <item>ensure that the powder is fully dissolved before drinking</item>
                  <item>do not drink if there are any clumps</item>
                  <item>do not use more than 7 days</item>
                </list>
              </item>
              <item>children 16 years of age or under: ask a doctor</item>
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          <title>Other information</title>
          <text>
            <list listType="unordered">
              <item>store at 20°-25°C (68°-77°F)</item>
              <item>tamper-evident: do not use if printed foil seal under cap 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>natural and artificial orange flavor, sucralose</paragraph>
          </text>
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          <title>Questions or comments?</title>
          <text>
            <paragraph>
              <content styleCode="bold">1-800-MiraLAX (1-800-647-2529)</content>
            </paragraph>
          </text>
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          <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
          <title>PRINCIPAL DISPLAY PANEL - 7 Dose Bottle</title>
          <text>
            <paragraph>MiraLAX ®</paragraph>
            <paragraph>Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative</paragraph>
            <paragraph>Relieves Occasional Constipation/Irregularity
  <br/>
Softens Stool
  <br/>
Grit-Free Powder
  <br/>
Sugar-Free &amp; Dye-Free
 </paragraph>
            <paragraph>ORANGE FLAVOR</paragraph>
            <paragraph>7 ONCE-DAILY DOSES</paragraph>
            <paragraph>NET WT 4.1 OZ (119 g)</paragraph>
            <paragraph>Bayer
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              <text>MiraLAX Orange 7 dose Front Label</text>
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