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    <content styleCode="italics">Drug Facts</content>
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          <title>
            <content styleCode="italics">Active ingredient (in each sealed capsule)</content>
          </title>
          <text>
            <paragraph>Orlistat 60 mg</paragraph>
          </text>
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          <title>
            <content styleCode="italics">Purpose</content>
          </title>
          <text>
            <paragraph>Weight loss aid</paragraph>
          </text>
          <effectiveTime value="20180419"/>
        </section>
      </component>
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          <title>
            <content styleCode="italics">Use</content>
          </title>
          <text>
            <list listType="unordered">
              <item>for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet</item>
            </list>
          </text>
          <effectiveTime value="20180419"/>
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          <title>
            <content styleCode="italics">Warnings</content>
          </title>
          <effectiveTime value="20221214"/>
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              <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
              <title>Organ transplant alert:</title>
              <text>
                <list listType="unordered">
                  <item>do not use if you have had an organ transplant. Orlistat interferes with the medicines used to prevent transplant rejection.</item>
                </list>
              </text>
              <effectiveTime value="20180419"/>
            </section>
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              <title>Allergy alert:</title>
              <text>
                <list listType="unordered">
                  <item>do not use if you are allergic to any of the ingredients in orlistat capsules</item>
                </list>
              </text>
              <effectiveTime value="20180419"/>
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              <title>Do not use</title>
              <text>
                <list listType="unordered">
                  <item>
                    <content styleCode="bold">if you are taking cyclosporine</content>
                  </item>
                  <item>if you have been diagnosed with problems absorbing food</item>
                  <item>if you are not overweight</item>
                </list>
              </text>
              <effectiveTime value="20180419"/>
            </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 ever had</title>
              <text>
                <list listType="unordered">
                  <item>gallbladder problems</item>
                  <item>kidney stones</item>
                  <item>pancreatitis</item>
                </list>
              </text>
              <effectiveTime value="20221214"/>
            </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>
                <list listType="unordered">
                  <item>taking any of the following prescription medications. Some prescription doses may need to be adjusted, or some medications may not work as well when used with orlistat.</item>
                  <item>anticoagulants (blood thinning medicine)</item>
                  <item>amiodarone (heart medicine)</item>
                  <item>diabetes medicine</item>
                  <item>thyroid disease medicine</item>
                  <item>seizure medicine</item>
                  <item>antiretrovirals (HIV medicine)</item>
                  <item>taking any other weight loss products</item>
                </list>
              </text>
              <effectiveTime value="20180419"/>
            </section>
          </component>
          <component>
            <section ID="i4i_OTC_When_Using_id_84676d06-4930-46ae-a698-15e9d84e9da3">
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              <code code="50567-7" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - WHEN USING SECTION"/>
              <title>When using this product</title>
              <text>
                <list listType="unordered">
                  <item>
                    <content styleCode="bold">take a multivitamin once a day, at bedtime</content>. Orlistat can reduce the absorption of some vitamins.
 
  </item>
                  <item>follow a well-balanced, reduced-calorie, low-fat diet. Try starting this diet before taking orlistat.</item>
                  <item>orlistat works by preventing the absorption of some of the fat you eat. The fat passes out of your body, so you may have bowel changes. You may get:
  
   <list listType="unordered">
                      <item>gas with oily spotting</item>
                      <item>loose stools</item>
                      <item>more frequent stools that may be hard to control</item>
                    </list>
                  </item>
                  <item>eating a low-fat diet lowers the chance of having these bowel changes</item>
                  <item>for every 5 pounds you lose from diet alone, orlistat can help you lose 2-3 pounds more. In studies, most people lost 5-10 pounds over 6 months.</item>
                </list>
              </text>
              <effectiveTime value="20221214"/>
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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 develop itching, yellow eyes or skin, dark urine or loss of appetite. There have been rare reports of liver injury in people taking orlistat.</item>
                  <item>severe or continuous abdominal pain occurs. This may be a sign of a serious medical condition.</item>
                  <item>you are taking medicine for seizures and your seizures happen more often or get worse</item>
                </list>
              </text>
              <effectiveTime value="20180419"/>
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              <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, do not use.</title>
              <effectiveTime value="20100804"/>
            </section>
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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"/>
              <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.</paragraph>
              </text>
              <effectiveTime value="20180419"/>
            </section>
          </component>
        </section>
      </component>
      <component>
        <section ID="i4i_dosage_admin_id_5c71ea1a-4669-410b-abe4-83913da47742">
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          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <title>
            <content styleCode="italics">Directions</content>
          </title>
          <text>
            <list listType="unordered">
              <item>read the enclosed brochure for other important information</item>
              <item>diet and exercise are the starting points for any weight loss program. Try these first before adding orlistat. Check with your doctor before starting any exercise program.</item>
              <item>to see if orlistat capsules are right for you, find your height on the chart to the right. You may consider starting a weight loss program with orlistat if your weight is the same or more than the weight shown for your height.</item>
              <item>
                <content styleCode="bold">for overweight adults 18 years and older:</content>
                <list listType="unordered">
                  <item>take 1 capsule with each meal containing fat</item>
                  <item>do not take more than 3 capsules daily</item>
                </list>
              </item>
              <item>use with a reduced-calorie, low-fat diet and exercise program until you reach your weight loss goal. Most weight loss occurs in the first 6 months.</item>
              <item>if you stop taking orlistat, continue with your diet and exercise program</item>
              <item>if you start to regain weight after you stop taking orlistat, you may need to start taking orlistat again along with your diet and exercise program</item>
              <item>
                <content styleCode="bold">take a multivitamin once a day, at bedtime, when using orlistat</content>
              </item>
            </list>
            <table width="100%">
              <col width="44%"/>
              <col width="56%"/>
              <tbody>
                <tr>
                  <td align="center" colspan="2" styleCode="Botrule Toprule " valign="top">
                    <paragraph>Ht. / Wt.</paragraph>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule Botrule " valign="top">
                    <paragraph>4’10”</paragraph>
                  </td>
                  <td styleCode="Botrule " valign="top">
                    <paragraph>129 lbs.</paragraph>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule Botrule " valign="top">
                    <paragraph>4’11”</paragraph>
                  </td>
                  <td styleCode="Botrule " valign="top">
                    <paragraph>133 lbs.</paragraph>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule Botrule " valign="top">
                    <paragraph>5’0”</paragraph>
                  </td>
                  <td styleCode="Botrule " valign="top">
                    <paragraph>138 lbs.</paragraph>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule Botrule " valign="top">
                    <paragraph>5’1”</paragraph>
                  </td>
                  <td styleCode="Botrule " valign="top">
                    <paragraph>143 lbs.</paragraph>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule Botrule " valign="top">
                    <paragraph>5’2”</paragraph>
                  </td>
                  <td styleCode="Botrule " valign="top">
                    <paragraph>147 lbs.</paragraph>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule Botrule " valign="top">
                    <paragraph>5’3”</paragraph>
                  </td>
                  <td styleCode="Botrule " valign="top">
                    <paragraph>152 lbs.</paragraph>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule Botrule " valign="top">
                    <paragraph>5’4”</paragraph>
                  </td>
                  <td styleCode="Botrule " valign="top">
                    <paragraph>157 lbs.</paragraph>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule Botrule " valign="top">
                    <paragraph>5’5”</paragraph>
                  </td>
                  <td styleCode="Botrule " valign="top">
                    <paragraph>162 lbs.</paragraph>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule Botrule " valign="top">
                    <paragraph>5’6”</paragraph>
                  </td>
                  <td styleCode="Botrule " valign="top">
                    <paragraph>167 lbs.</paragraph>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule Botrule " valign="top">
                    <paragraph>5’7”</paragraph>
                  </td>
                  <td styleCode="Botrule " valign="top">
                    <paragraph>172 lbs.</paragraph>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule Botrule " valign="top">
                    <paragraph>5’8”</paragraph>
                  </td>
                  <td styleCode="Botrule " valign="top">
                    <paragraph>177 lbs.</paragraph>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule Botrule " valign="top">
                    <paragraph>5’9”</paragraph>
                  </td>
                  <td styleCode="Botrule " valign="top">
                    <paragraph>182 lbs.</paragraph>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule Botrule " valign="top">
                    <paragraph>5’10”</paragraph>
                  </td>
                  <td styleCode="Botrule " valign="top">
                    <paragraph>188 lbs.</paragraph>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule Botrule " valign="top">
                    <paragraph>5’11”</paragraph>
                  </td>
                  <td styleCode="Botrule " valign="top">
                    <paragraph>193 lbs.</paragraph>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule Botrule " valign="top">
                    <paragraph>6’0”</paragraph>
                  </td>
                  <td styleCode="Botrule " valign="top">
                    <paragraph>199 lbs.</paragraph>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule Botrule " valign="top">
                    <paragraph>6’1”</paragraph>
                  </td>
                  <td styleCode="Botrule " valign="top">
                    <paragraph>204 lbs.</paragraph>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule Botrule " valign="top">
                    <paragraph>6’2”</paragraph>
                  </td>
                  <td styleCode="Botrule " valign="top">
                    <paragraph>210 lbs.</paragraph>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule Botrule " valign="top">
                    <paragraph>6’3”</paragraph>
                  </td>
                  <td styleCode="Botrule " valign="top">
                    <paragraph>216 lbs.</paragraph>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule Botrule " valign="top">
                    <paragraph>6’4”</paragraph>
                  </td>
                  <td styleCode="Botrule " valign="top">
                    <paragraph>221 lbs.</paragraph>
                  </td>
                </tr>
                <tr>
                  <td styleCode="Rrule Botrule " valign="top">
                    <paragraph>6’5”</paragraph>
                  </td>
                  <td styleCode="Botrule " valign="top">
                    <paragraph>227 lbs.</paragraph>
                  </td>
                </tr>
              </tbody>
            </table>
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          <title>
            <content styleCode="italics">Other information</content>
          </title>
          <text>
            <list listType="unordered">
              <item>store at 20 - 25
  
   <sup>o</sup>C (68 - 77
  
   <sup>o</sup>F)
 
  </item>
              <item>protect drug from excessive light, humidity and temperatures over 30
  
   <sup>o</sup>C (86
  
   <sup>o</sup>F)
 
  </item>
            </list>
          </text>
          <effectiveTime value="20180419"/>
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          <title>
            <content styleCode="italics">Inactive ingredients</content>
          </title>
          <text>
            <paragraph>FD&amp;C Blue No. 2, edible ink, gelatin, iron oxide, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, titanium dioxide</paragraph>
          </text>
          <effectiveTime value="20180419"/>
        </section>
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          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <title>
            <content styleCode="italics">Questions or comments?</content>
          </title>
          <text>
            <paragraph>call toll-free
 
  <content styleCode="bold">1-800-671-2554</content>
            </paragraph>
          </text>
          <effectiveTime value="20240116"/>
          <component>
            <section ID="ID_c8c4c632-1481-4537-b09b-f991c6ed80ad">
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              <title>Additional information</title>
              <text>
                <paragraph>
                  <content styleCode="bold">
                    <content styleCode="italics">The Starter Pack includes:</content>
                  </content>
                </paragraph>
                <list listType="unordered">
                  <item>Read Me First brochure</item>
                  <item>Up to 20 day supply (60 capsules)</item>
                </list>
                <paragraph>
                  <content styleCode="bold">For more information, visit www.myalli.com</content>
                </paragraph>
                <paragraph>
                  <content styleCode="bold">TAMPER- EVIDENT features for your protection. The package has a security seal on both ends of the carton printed with the GSK logo. The bottle of capsules has a foil seal under the cap imprinted with the words “sealed for your protection”. Each individual capsule is sealed with a dark blue band around the center of the capsule. DO NOT USE THIS PRODUCT IF ANY OF THESE TAMPER-EVIDENT FEATURES ARE MISSING, TORN OR BROKEN.</content>
                </paragraph>
                <paragraph>For more information and to learn more about
 
  <content styleCode="bold">alli</content>, visit us at www.my
 
  <content styleCode="bold">alli</content>.com.

 </paragraph>
                <list listType="unordered">
                  <item>1-800-671-2554</item>
                </list>
                <paragraph>Distributed by:</paragraph>
                <paragraph>
                  <content styleCode="bold">Haleon,</content>Warren, NJ 07059

 </paragraph>
                <paragraph>Trademarks are owned by or licensed to the Haleon group of companies.</paragraph>
                <paragraph>©2023 Haleon group of companies or its licensor.</paragraph>
                <paragraph>Made in India</paragraph>
              </text>
              <effectiveTime value="20240116"/>
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          <title>REPACKAGING INFORMATION</title>
          <text>
            <paragraph>Please reference the HOW SUPPLIED section listed above for a description of drug product's characteristics. This drug product has been received by Aphena Pharma Solutions - Tennessee, LLC in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
  <br/>
            </paragraph>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="underline">60mg</content>
              </content>
              <br/>
NDC 71610-805-34, Bottles of 2280 Capsules
 </paragraph>
            <paragraph>
              <br/>
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
  <br/>
              <br/>
Repackaged by:
  <br/>
              <renderMultiMedia referencedObject="img_14a76e28-bda5-485a-e063-6394a90ad3c4"/>
              <br/>
Cookeville,TN 38506
  <br/>
              <br/>
20240327JK
 </paragraph>
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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 - 60mg</title>
          <text>
            <paragraph>NDC 71610-805 - Orlistat (Alli) 60mg Capsules - Rx Only</paragraph>
            <paragraph>
              <renderMultiMedia referencedObject="img_14a77184-de3c-5aa5-e063-6394a90aaf54"/>
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          <effectiveTime value="20240327"/>
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              <text>71610-805-34</text>
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