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   <title> Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP<br/>
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                        <name>Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride</name>
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                              <denominator value="1" unit="1"/>
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                              <originalText>circular</originalText>
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               <title>Active ingredients</title>
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                  <paragraph/>
                  <paragraph>Cetirizine HCl, USP 5 mg<br/>Pseudoephedrine HCl, USP 120 mg</paragraph>
               </text>
               <effectiveTime value="20241127"/>
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               <title>Purposes</title>
               <text>
                  <paragraph/>
                  <paragraph>Antihistamine<br/>Nasal decongestant</paragraph>
               </text>
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               <title>Uses</title>
               <text>
                  <list listType="unordered" styleCode="Disc">
                     <item>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:<list listType="unordered" styleCode="Disc">
                           <item>runny nose</item>
                           <item>sneezing</item>
                           <item>itchy, watery eyes</item>
                           <item>itching of the nose or throat</item>
                           <item>nasal congestion</item>
                        </list>
                     </item>
                     <item>reduces swelling of nasal passages</item>
                     <item>temporarily relieves sinus congestion and pressure</item>
                     <item>temporarily restores freer breathing through the nose</item>
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               <title>Warnings</title>
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               <title>Do not use</title>
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                  <list listType="unordered" styleCode="Disc">
                     <item>if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.</item>
                     <item>if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (cer tain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks af ter stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.</item>
                  </list>
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               <title>Ask a doctor before use if you have</title>
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                  <list listType="unordered" styleCode="Disc">
                     <item>heart disease</item>
                     <item>thyroid disease</item>
                     <item>diabetes</item>
                     <item>glaucoma</item>
                     <item>high blood pressure</item>
                     <item>trouble urinating due to an enlarged prostate gland</item>
                     <item>liver or kidney disease. Your doctor should determine if you need a different dose.</item>
                  </list>
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               <title>Ask a doctor or pharmacist before use if you are</title>
               <text>
                  <paragraph/>
                  <paragraph>taking tranquilizers or sedatives.</paragraph>
               </text>
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               <title>When using this product</title>
               <text>
                  <list listType="unordered" styleCode="Disc">
                     <item>
                        <content styleCode="bold">do not use more than directed </content>
                     </item>
                     <item>drowsiness may occur</item>
                     <item>avoid alcoholic drinks</item>
                     <item>alcohol, sedatives, and tranquilizers may increase drowsiness</item>
                     <item>be careful when driving a motor vehicle or operating machinery</item>
                  </list>
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               <title>Stop use and ask a doctor if</title>
               <text>
                  <list listType="unordered" styleCode="Disc">
                     <item>an allergic reaction to this product occurs. Seek medical help right away.</item>
                     <item>you get nervous, dizzy, or sleepless</item>
                     <item>symptoms do not improve within 7 days or are accompanied by fever</item>
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               <title>If pregnant or breast-feeding:</title>
               <text>
                  <list listType="unordered" styleCode="Disc">
                     <item>if breast-feeding: not recommended</item>
                     <item>if pregnant: ask a health professional before use.</item>
                  </list>
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               <title>Keep out of reach of children.</title>
               <text>
                  <paragraph/>
                  <paragraph>In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).</paragraph>
               </text>
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               <title>Directions</title>
               <text>
                  <list listType="unordered" styleCode="Disc">
                     <item>do not break or chew tablet; swallow tablet whole</item>
                  </list>
                  <table cellspacing="0" cellpadding="0">
                     <tbody>
                        <tr styleCode="Botrule First">
                           <td styleCode="Lrule Rrule" valign="middle">adults and children 12 years and over</td>
                           <td styleCode="Rrule" valign="middle">take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.</td>
                        </tr>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule Rrule" valign="middle">adults 65 years and over</td>
                           <td styleCode="Rrule" valign="middle">ask a doctor</td>
                        </tr>
                        <tr styleCode="Botrule">
                           <td styleCode="Lrule Rrule" valign="middle">children under 12 years of age</td>
                           <td styleCode="Rrule" valign="middle">ask a doctor</td>
                        </tr>
                        <tr>
                           <td styleCode="Lrule Rrule" align="left" valign="middle">consumers with liver or kidney disease</td>
                           <td styleCode="Rrule" valign="middle">ask a doctor</td>
                        </tr>
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               <title>Other information</title>
               <text>
                  <list listType="unordered" styleCode="Disc">
                     <item>store between 20° to 25°C (68° to 77°F) </item>
                     <item>
                        <content styleCode="bold">Do not use if carton is opened or if the blister unit is broken</content>
                     </item>
                     <item>See side panel for lot number and expiration date</item>
                  </list>
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                  <paragraph/>
                  <paragraph>hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid, titanium dioxide <br/>Imprinting Ink Contents: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac glaze</paragraph>
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               <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
               <title>Questions?</title>
               <text>
                  <paragraph/>
                  <paragraph>Call toll free <content styleCode="bold">1-800-818-4555</content> weekdays</paragraph>
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               <title>Principal Display Panel - Showbox</title>
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                  <paragraph>
                     <content styleCode="bold">NDC 62756-915-62</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Original Prescription Strength</content>
                     <br/>
                     <content styleCode="bold">Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release Tablets, USP</content>
                     <br/>
                     <content styleCode="bold">5 mg/120 mg</content>
                     <br/>
                     <content styleCode="bold">Antihistamine/Nasal Decongestant</content>
                     <br/>
                     <content styleCode="bold">Indoor &amp; Outdoor Allergies</content>
                     <br/>
                     <content styleCode="bold">ALLERGY &amp; SINUS</content>
                     <br/>
                     <content styleCode="bold">SUN PHARMA</content>
                     <br/>
                     <content styleCode="bold">Actual Size</content>
                     <br/>
                     <content styleCode="bold">DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN</content>
                     <br/>
                     <content styleCode="bold">12 Tablets (2 blister cards of 6 tablets each)</content>
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                  <paragraph/>
                  <paragraph>
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               <effectiveTime value="20241127"/>
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                     <text>13</text>
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            </section>
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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 - Blister pack</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="bold">Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablet, USP</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="bold">5 mg/120 mg</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Mfg. by: Sun Pharmaceutical Ind. Ltd. India.</content>
                  </paragraph>
                  <paragraph>
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                  <observationMedia ID="MM2">
                     <text>spl-cetirizine-pseudoephedrine-blister</text>
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