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                  <paragraph>Omeprazole USP 20 mg</paragraph>
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               <title>Purpose</title>
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               <title>Use</title>
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                  <list listType="unordered" styleCode="disc">
                     <item>treats frequent heartburn (occurs <content styleCode="bold">2 or more</content> days a week)</item>
                     <item>not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect</item>
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                  <paragraph>
                     <content styleCode="bold">Allergy alert:</content>
                     <br/> do not use if you are allergic to omeprazole<br/> • omeprazole may cause severe skin reactions. Symptoms may include:<br/> • skin reddening • blisters • rash<br/> If an allergic reaction occurs, stop use and seek medical help right away.</paragraph>
                  <br/>
                  <br/>
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               <title>Do not use</title>
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                  <paragraph>
                     <content styleCode="bold">if you have:</content>
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                  <list listType="unordered" styleCode="disc">
                     <item>trouble or pain swallowing food, vomiting with blood, or bloody or black stools</item>
                     <item>heartburn with <content styleCode="bold">lightheadedness, sweating or dizziness</content>
                     </item>
                     <item>chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness</item>
                     <item>frequent <content styleCode="bold">chest pain</content>
                     </item>
                  </list>
                  <paragraph>These may be signs of a serious condition. See your doctor.</paragraph>
               </text>
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            </section>
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            <section ID="Section_5">
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               <code code="50569-3" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR SECTION"/>
               <title>Ask a docotor before use if you have:</title>
               <text>
                  <list listType="unordered" styleCode="disc">
                     <item>had heartburn over 3 months. This may be a sign of a more serious condition.</item>
                     <item>frequent wheezing, particularly with heartburn</item>
                     <item>unexplained weight loss</item>
                     <item>nausea or vomiting</item>
                     <item>stomach pain</item>
                  </list>
                  <br/>
                  <br/>
               </text>
               <effectiveTime value="20250428"/>
            </section>
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               <code code="50568-5" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR/PHARMACIST SECTION"/>
               <title>Ask a doctor or pharmacist before use if you are</title>
               <text>
                  <paragraph>taking a prescription drug. Acid reducers may interact with certain prescription drugs.</paragraph>
                  <paragraph/>
               </text>
               <effectiveTime value="20250428"/>
            </section>
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         <component>
            <section ID="Section_8">
               <id root="ec4b5121-c0d2-4b14-97ed-ea465e224de0"/>
               <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>
                  <br/>
                  <list listType="unordered" styleCode="disc">
                     <item>your heartburn continues or worsens</item>
                     <item>you need to take this product for more than 14 days</item>
                     <item>you need to take more than 1 course of treatment every 4 months</item>
                     <item>you get diarrhea</item>
                     <item>you develop a rash or joint pain</item>
                  </list>
                  <br/>
               </text>
               <effectiveTime value="20250428"/>
            </section>
         </component>
         <component>
            <section ID="Section_10">
               <id root="1c4260e7-ad9c-47ce-8ad2-d47d82b1a9b2"/>
               <code code="53414-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PREGNANCY OR BREAST FEEDING SECTION"/>
               <title>If pregnant or breast-feeding,</title>
               <text>
                  <paragraph>ask a health professional before use.</paragraph>
               </text>
               <effectiveTime value="20250428"/>
            </section>
         </component>
         <component>
            <section ID="Section_11">
               <id root="12afdb64-f123-4c3f-8258-20542dfba46b"/>
               <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
               <title>Keep out of reach of children.</title>
               <text>
                  <paragraph>In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)</paragraph>
               </text>
               <effectiveTime value="20250428"/>
            </section>
         </component>
         <component>
            <section ID="Section_12">
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               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>Directions</title>
               <text>
                  <paragraph/>
                  <list listType="unordered" styleCode="Disc">
                     <item>for adults 18 years of age and older</item>
                     <item>this product is to be used once a day (every 24 hours), every day for 14 days</item>
                     <item>it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours</item>
                  </list>
                  <paragraph>
                     <content styleCode="bold">14-Day Course of Treatment</content>
                  </paragraph>
                  <list listType="unordered" styleCode="Disc">
                     <item>swallow 1 tablet with a glass of water before eating in the morning</item>
                     <item>take every day for 14 days</item>
                     <item>do not take more than 1 tablet a day</item>
                     <item>do not use for more than 14 days unless directed by your doctor</item>
                     <item>swallow whole. Do not chew or crush tablets.</item>
                  </list>
                  <paragraph>
                     <content styleCode="bold">Repeated 14-Day Courses (if needed)</content>
                  </paragraph>
                  <list listType="unordered" styleCode="Disc">
                     <item>you may repeat a 14-day course every 4 months</item>
                     <item>
                        <content styleCode="bold">do not take for more than 14 days or more often than every 4 months unless directed by a doctor</content>
                     </item>
                     <item>children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition. </item>
                  </list>
               </text>
               <effectiveTime value="20250428"/>
            </section>
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               <title>Other information</title>
               <text>
                  <list listType="unordered" styleCode="disc">
                     <item>read the directions and warnings before use </item>
                     <item>keep the carton. It contains important information. </item>
                     <item>store at 20 to 25° C (68 to 77° F) and protect from moisture</item>
                  </list>
               </text>
               <effectiveTime value="20250428"/>
            </section>
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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>anhydrous lactose, hypromellose, hypromellose acetate succinate, iron oxide red, iron oxide yellow, lactose monohydrate, methyl cellulose, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, triethyl citrate and titanium dioxide.</paragraph>
                  <paragraph>The imprinting ink contains ammonium hydroxide, black iron oxide, n-butyl alcohol, propylene glycol and shellac.</paragraph>
               </text>
               <effectiveTime value="20250428"/>
            </section>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Questions or Comments?</title>
               <text>
                  <paragraph/>
                  <paragraph>Call toll free 1-800-818-4555 weekdays.</paragraph>
               </text>
               <effectiveTime value="20250428"/>
            </section>
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            <section ID="Unclassified_Section_4">
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Tips of Managing Heartburn</title>
               <text>
                  <list listType="unordered" styleCode="Disc">
                     <item>Do not lie flat or bend over after eating</item>
                     <item>Do not wear tight-fitting clothing around the stomach</item>
                     <item>Do not eat before bedtime</item>
                     <item>Raise the head of your bed</item>
                     <item>Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetables</item>
                     <item>Eat slowly and avoid big meals</item>
                     <item>If overweight, lose weight</item>
                     <item>Quit smoking</item>
                  </list>
               </text>
               <effectiveTime value="20250428"/>
            </section>
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         <component>
            <section ID="Section_18">
               <id root="18e36ca9-971d-439b-a71a-71a661192118"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Principal Display Panel - Foil</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">62756-377-40</content>
                     <br/>
                     <content styleCode="bold">Omeprazole Delayed-Release Tablet</content>
                     <br/>
                     <content styleCode="bold">20 mg</content>
                     <br/>
                     <content styleCode="bold">Acid Reducer</content>
                     <br/> PUSH THROUGH</paragraph>
                  <paragraph>
                     <content>Take 1 tablet a day fo 14 days</content>
                  </paragraph>
                  <paragraph> Mfg. by: <content styleCode="bold">Sun Pharmaceutical Ind Ltd</content>., India.<br/> Dist. by: <content styleCode="bold">Sun Pharmaceutical Ind Inc</content>., NJ 08512<br/> PGPF0520A</paragraph>
                  <paragraph>
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                  </paragraph>
               </text>
               <effectiveTime value="20250428"/>
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                     <text>spl-omeprazole-foil</text>
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            </section>
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         <component>
            <section ID="Section_16">
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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 Carton</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">NDC 62756-377-96<br/>
                     </content>
                     <content styleCode="bold">Compare to Prilosec OTC ® *</content>
                     <br/> Treats <content styleCode="bold">Frequent</content> Heartburn! <content styleCode="bold">(24 HR)</content>
                  </paragraph>
                  <br/>
                  <paragraph>
                     <content styleCode="bold">Compare to Prilosec OTC <sup>® *</sup>
                        <br/> Omeprazole Delayed-release Tablets<br/> 20 mg</content>
                     <br/>
                     <content styleCode="bold">Acid Reducer</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">SWALLOW - DO NOT CHEW<br/> 28 (2 x 14) Unit-Dose Tablets<br/> TWO 14-DAY COURSES OF TREATMENT<br/> May take 1 to 4 days for full effect<br/>
                     </content>
                  </paragraph>
                  <content styleCode="bold">
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                  </content>
               </text>
               <effectiveTime value="20250428"/>
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                     <text>spl-omeprazole-carton-2</text>
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            </section>
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         <component>
            <section ID="Section_17">
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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 - Label</title>
               <text>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">NDC 62756-377-21</content>
                     <br/> Treats<content styleCode="bold">
                        <content styleCode="bold">Frequent</content>
                     </content>Heartburn!<content styleCode="bold">(24 HR)</content>
                     <br/>
                     <content styleCode="bold">Omeprazole Delayed-release Tablets</content>
                     <br/>
                     <content styleCode="bold">20 mg</content>
                     <br/>
                     <content styleCode="bold">Acid Reducer</content>
                     <br/>
                     <content styleCode="bold">14 Tablets</content>
                     <br/>
                     <content styleCode="bold">ONE 14-DAY COURSE OF TREATMENT<br/> May take 1 to 4 days for full effect<br/>
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                     </content>
                  </paragraph>
               </text>
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                     <text>spl-omeprazole-label</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 - Bottle Carton</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">NDC 62756-377-11</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Compare to Prilosec OTC ® *</content>
                     <br/>Treats <content styleCode="bold">Frequent</content> Heartburn<content styleCode="bold">! </content>
                     <content styleCode="bold">(24 HR)</content>
                     <br/>
                     <content styleCode="bold">Omeprazole Delayed-release Tablets</content>
                     <br/>
                     <content styleCode="bold">20 mg</content>
                     <br/>
                     <content styleCode="bold">Acid Reducer</content>
                     <br/>
                     <content styleCode="bold">SWALLOW - DO NOT CHEW</content>
                     <br/>
                     <content styleCode="bold">28 Tablets</content>
                     <br/>
                     <content styleCode="bold">TWO 14-DAY COURSES OF TREATMENT</content>
                     <br/>
                     <content styleCode="bold">May take 1 to 4 days for full effect<br/>
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                     </content>
                  </paragraph>
               </text>
               <effectiveTime value="20250428"/>
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                  <observationMedia ID="MM4">
                     <text>spl-omeprazole-carton-28-tab</text>
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