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   <title>Pamprin Max Menstrual Pain Relief</title>
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                        <name>Pamprin Max Menstrual Pain Relief</name>
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                              <name>Acetaminophen and Aspirin and Caffeine</name>
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                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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                              <originalText>FD &amp; C Red No. 40</originalText>
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                              <originalText>D&amp;C REd No. 27</originalText>
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               <text>
                  <paragraph>Pain reliever</paragraph>
                  <paragraph>Diuretic</paragraph>
                  <paragraph>*nonsteroidal anti-inflammatory drug</paragraph>
               </text>
               <effectiveTime value="20171018"/>
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               <text>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">(in each caplet)</content>
                     </content>
                  </paragraph>
                  <paragraph>Acetaminophen 250 mg</paragraph>
                  <paragraph>Aspirin 250 mg</paragraph>
                  <paragraph>Caffeine 65 mg</paragraph>
               </text>
               <effectiveTime value="20171018"/>
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               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <text>
                  <paragraph>D&amp;C Red No. 27 Lake, FD&amp;C Red No. 40 Lake, fractionated coconut oil, hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, starch, stearic acid, talc, titanium dioxide (245-171)</paragraph>
               </text>
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               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <text>
                  <paragraph>For the temporary relief of these symptoms associated with menstrual periods:</paragraph>
                  <list listType="unordered" styleCode="Disc">
                     <item>cramps
   
        
  
   <br/>
                     </item>
                     <item>headache
   
        
  
   <br/>
                     </item>
                     <item>backache
   
        
  
   <br/>
                     </item>
                     <item>fatigue
   
        
  
   <br/>
                     </item>
                     <item>bloating</item>
                  </list>
               </text>
               <effectiveTime value="20171018"/>
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               <text>
                  <paragraph>
                     <content styleCode="bold">Reye’s syndrome:</content> Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.
 </paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">Allergy alert:</content> Aspirin may cause a severe allergic reaction which may include:
 </paragraph>
                  <list listType="unordered" styleCode="Disc">
                     <item>hives
   <br/>
                     </item>
                     <item>facial swelling
   <br/>
                     </item>
                     <item>asthma (wheezing)
   <br/>
                     </item>
                     <item>shock</item>
                  </list>
                  <paragraph>
                     <content styleCode="bold">Allergy warning:  </content>Acetaminophen may cause severe skin reactions.  Symptoms may include:
 </paragraph>
                  <list listType="unordered">
                     <item>skin reddening</item>
                     <item>blisters</item>
                     <item>rash</item>
                  </list>
                  <paragraph>If a skin reaction occurs, stop use and seek medical help right away. </paragraph>
                  <paragraph>
                     <content styleCode="bold">Liver warning:</content> This product contains acetaminophen. Severe liver damage may occur if you take
 </paragraph>
                  <list listType="unordered" styleCode="Disc">
                     <item>more than 8 caplets in 24 hours, which is the maximum daily amount
   <br/>
                     </item>
                     <item>with other drugs containing acetaminophen
   <br/>
                     </item>
                     <item>3 or more alcoholic drinks every day while using this product</item>
                     <item/>
                  </list>
                  <paragraph>
                     <content styleCode="bold">Stomach bleeding warning:</content> This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
 </paragraph>
                  <list listType="unordered" styleCode="Disc">
                     <item>are age 60 or older
   <br/>
                     </item>
                     <item>have had stomach ulcers or bleeding problems
   <br/>
                     </item>
                     <item>take a blood thinning (anticoagulant) or steroid drug
   <br/>
                     </item>
                     <item>take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
   <br/>
                     </item>
                     <item>have 3 or more alcoholic drinks every day while using this product
   <br/>
                     </item>
                     <item>take more or for a longer time than directed</item>
                  </list>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">Caffeine warning:</content> The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.
 </paragraph>
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                     <title>
                        <content styleCode="bold">Do not use</content>
                     </title>
                     <text>
                        <paragraph>• if you are allergic to aspirin or any other pain reliever/fever reducer</paragraph>
                        <paragraph>• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.</paragraph>
                     </text>
                     <effectiveTime value="20120628"/>
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               <component>
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                     <code code="50569-3" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR SECTION"/>
                     <title>
                        <content styleCode="bold">Ask a doctor before use if</content>
                     </title>
                     <text>
                        <list listType="unordered" styleCode="Disc">
                           <item>you have liver disease
          
  
   
          
  
   <br/>
                           </item>
                           <item>the stomach bleeding warning applies to you
          
  
   
          
  
   <br/>
                           </item>
                           <item>you have a history of stomach problems, such as heartburn
          
  
   
          
  
   <br/>
                           </item>
                           <item>you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
          
  
   
          
  
   <br/>
                           </item>
                           <item>you are taking a diuretic</item>
                        </list>
                     </text>
                     <effectiveTime value="20120628"/>
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                     <title>
                        <content styleCode="bold">Ask a doctor or pharmacist before</content>
                        <content styleCode="bold"> </content>
                        <content styleCode="bold">use</content>
                     </title>
                     <text>
                        <paragraph> if you are taking a prescription drug for gout, diabetes or arthritis</paragraph>
                     </text>
                     <effectiveTime value="20120628"/>
                  </section>
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                     <id root="92d53de9-7698-4a29-e053-2a95a90aa017"/>
                     <code code="50566-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - STOP USE SECTION"/>
                     <title>
                        <content styleCode="bold">Stop use and ask a doctor if</content>
                     </title>
                     <text>
                        <list listType="unordered" styleCode="Disc">
                           <item>an allergic reaction occurs. Seek medical help right away.
          
  
   
          
  
   <br/>
                           </item>
                           <item>you experience any of the following signs of stomach bleeding:
          
  
   
          
  
   <list listType="unordered">
                                 <item>feel faint 
            
    
     
            
    
     <br/>
                                 </item>
                                 <item>vomit blood
            
    
     
            
    
     <br/>
                                 </item>
                                 <item>have bloody or black stools
            
    
     
            
    
     <br/>
                                 </item>
                                 <item>have stomach pain that does not get better</item>
                              </list>
                           </item>
                        </list>
                        <list listType="unordered" styleCode="Disc">
                           <item>redness or swelling is present
          
  
   
          
  
   <br/>
                           </item>
                           <item>new symptoms occur
          
  
   
          
  
   <br/>
                           </item>
                           <item>pain gets worse or lasts more than 10 days
          
  
   
          
  
   <br/>
                           </item>
                           <item>fever gets worse or lasts more than 3 days
          
  
   
          
  
   <br/>
                           </item>
                           <item>ringing in the ears or loss of hearing occurs</item>
                        </list>
                     </text>
                     <effectiveTime value="20120628"/>
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                     <code code="53414-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PREGNANCY OR BREAST FEEDING SECTION"/>
                     <title>
                        <content styleCode="bold">If pregnant or breast-feeding, </content>
                     </title>
                     <text>
                        <paragraph>ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.</paragraph>
                     </text>
                     <effectiveTime value="20120628"/>
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                     <title>
                        <content styleCode="bold">Keep out of reach of children. </content>
                     </title>
                     <text>
                        <paragraph>In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.</paragraph>
                     </text>
                     <effectiveTime value="20120628"/>
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                  <paragraph>
                     <content styleCode="bold">When using this product</content>
                  </paragraph>
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                     <item>you may get drowsy, avoid alcoholic beverages</item>
                     <item>alcohol sedatives and tranquilizers may increase drowsiness</item>
                     <item>use caution when driving or operating machinery</item>
                     <item>excitability may occur especially in children</item>
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                  <paragraph>
                     <content styleCode="bold">stop use and ask doctor if</content>
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                     <item>pain gets worse or lasts for more than 10 days</item>
                     <item>fever gets worse or lasts for more than 3 days </item>
                     <item>new symptoms occur </item>
                     <item>redness or swelling is present</item>
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                  <paragraph>
                     <content styleCode="bold">If pregnant or breastfeeding, </content>ask a health professional before use. 
 
      

 </paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">Keep out of reach of children. </content>In case of overdose, get medical help or contact a poison control center right away.
 
      

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                  <paragraph>Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.</paragraph>
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                     <content styleCode="bold"/>
                     <content styleCode="bold">12 years and over:</content>
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                  <paragraph>• take 2 caplets with water every 6 hours as needed</paragraph>
                  <paragraph>• do not exceed 8 caplets in a 24 hour period or as directed by a doctor</paragraph>
                  <paragraph>• do not use more than directed (see warnings)</paragraph>
                  <paragraph>
                     <content styleCode="bold">children under 12 years:</content> ask a doctor
 
      

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