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   <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
   <title>Drug Facts</title>
   <effectiveTime value="20130115"/>
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   <versionNumber value="1"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id extension="688445679" root="1.3.6.1.4.1.519.1"/>
            <name>Kafus Co., Ltd</name>
            <assignedEntity>
               <assignedOrganization>
                  <id extension="688445679" root="1.3.6.1.4.1.519.1"/>
                  <name>Kafus Co., Ltd</name>
                  <assignedEntity>
                     <assignedOrganization>
                        <id extension="687745240" root="1.3.6.1.4.1.519.1"/>
                        <name>Dong Hwa Pharm Co., Ltd</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
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                           <product>
                              <manufacturedProduct classCode="MANU">
                                 <manufacturedMaterialKind>
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                                 </manufacturedMaterialKind>
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               <effectiveTime value="20121231"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="55277-1001" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>PANCOLD S
                <suffix/>
                        </name>
                        <formCode code="C42953" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="LIQUID"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>GUAIFENESIN</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
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                           <quantity>
                              <numerator value="83.3" unit="mg"/>
                              <denominator value="30" unit="mL"/>
                           </quantity>
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                              <code code="495W7451VQ" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>GUAIFENESIN</name>
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                                    <code code="495W7451VQ" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>GUAIFENESIN</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="3K9958V90M" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>ALCOHOL</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="2968PHW8QP" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>CITRIC ACID MONOHYDRATE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="XY6UN3QB6S" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>HIGH FRUCTOSE CORN SYRUP</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="24RS0A988O" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>LEMON</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="A2I8C7HI9T" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>METHYLPARABEN</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="W81N5U6R6U" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>MONOSODIUM GLUTAMATE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="5EVU04N5QU" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>ORANGE</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="Z8IX2SC1OH" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>PROPYLPARABEN</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="OJ245FE5EU" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>SODIUM BENZOATE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="451W47IQ8X" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>SODIUM CHLORIDE</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="I753WB2F1M" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>FD&amp;C YELLOW NO. 5</name>
                           </ingredientSubstance>
                        </ingredient>
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                              <numerator value="30" unit="mg"/>
                              <denominator value="30" unit="mL"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="3G6A5W338E" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>CAFFEINE</name>
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                                    <code code="3G6A5W338E" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>CAFFEINE</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="2.5" unit="mg"/>
                              <denominator value="30" unit="mL"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="3U6IO1965U" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>CHLORPHENIRAMINE</name>
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                                 <activeMoiety>
                                    <code code="3U6IO1965U" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>CHLORPHENIRAMINE</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
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                           <quantity>
                              <numerator value="17.5" unit="mg"/>
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                           </quantity>
                           <ingredientSubstance>
                              <code code="99214P83XM" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>METHYLEPHEDRINE HYDROCHLORIDE, DL-</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="SHS9PGQ2LS" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>METHYLEPHEDRINE, DL-</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
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                           <quantity>
                              <numerator value="300" unit="mg"/>
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                              <code code="362O9ITL9D" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>ACETAMINOPHEN</name>
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                                 <activeMoiety>
                                    <code code="362O9ITL9D" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>ACETAMINOPHEN</name>
                                 </activeMoiety>
                              </activeMoiety>
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                              <numerator value="30" unit="mL"/>
                              <denominator value="1"/>
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                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20130115"/>
                           </effectiveTime>
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                     <subjectOf>
                        <approval>
                           <id extension="part341" root="2.16.840.1.113883.3.149"/>
                           <code code="C73603" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="OTC monograph final"/>
                           <author>
                              <territorialAuthority>
                                 <territory>
                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                 </territory>
                              </territorialAuthority>
                           </author>
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                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/>
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               <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
               <text>Guaifenesin<br/>Caffeine anhydrous<br/>Chlorpheniramine maleate<br/>dl-methylephedrine hydrochloride<br/>Acetaminophen<br/>
               </text>
               <effectiveTime value="20130115"/>
            </section>
         </component>
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               <id root="d2a93caa-a639-4996-8556-7fbc3b8f62b9"/>
               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <text>alcohol, citric acid, edentate sodium, high fructose corn syrup, lemon essence, methylparaben, monosodium glutamate, orange essence, propylene glycol, propylparaben, sodium benzoate, sodium chloride, water, tartrazine<br/>
               </text>
               <effectiveTime value="20130115"/>
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               <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
               <text>Temporarily relieves these minor symptoms due to a cold or the flu:<br/>▪aches ▪pain ▪headache ▪sore throat ▪muscular aches ▪fever<br/>▪rummy nose ▪sneezing ▪itching of the nose and throat<br/>▪nasal congestion ▪sinus congestion and pressure<br/>▪cough due to minor throat and bronchial irritation<br/>
               </text>
               <effectiveTime value="20130115"/>
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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>keep out or reach of the children<br/>
               </text>
               <effectiveTime value="20130115"/>
            </section>
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               <text>
                  <content>Adults and children 12 years and older: Take 1 bottle every 4 hours, while symptoms persist not to exceed 6 bottles in 24 hours, or as directed by a doctor.<br/>
                  </content>
               </text>
               <effectiveTime value="20130115"/>
            </section>
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               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <text>Alcohol warning:<br/>▪If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. ▪Acetaminophen may cause liver damage.</text>
               <effectiveTime value="20130115"/>
            </section>
         </component>
         <component>
            <section>
               <id root="840a8715-eb27-4f9b-b1a7-f0fe4e9a18ae"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <text>for oral use only<br/>
               </text>
               <effectiveTime value="20130115"/>
            </section>
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               </text>
               <effectiveTime value="20130115"/>
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                     <text>package label</text>
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