<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="6110296">
  <adverse_event_report>
    <yyqq>06Q3</yyqq>
    <isr>5083511</isr>
    <initial_followup_code>I</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>5083511-8</image>
    <event_date>2006-01-01</event_date>
    <manufacturer_date>2006-08-03</manufacturer_date>
    <fda_date>2006-08-18</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>US-JNJFOC-20060803572</manufacturer_number>
    <manufacturer_sending>MCNEIL CONSUMER PRODUCTS USA REGULATORY REPORTING</manufacturer_sending>
    <age></age>
    <age_units></age_units>
    <gender>F</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date>2006-08-18</report_date>
    <reporter_occupation>CN</reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified>false</manufacturer_notified>
    <confidentiality_status>false</confidentiality_status>
    <reporter_country>UNITED STATES</reporter_country>
    <outcome outcome_code="OT"/>
    <reaction reaction_preferred_term="CONSTIPATION"/>
    <reaction reaction_preferred_term="DRUG INTERACTION"/>
    <reaction reaction_preferred_term="FLATULENCE"/>
    <reaction reaction_preferred_term="NARCOLEPSY"/>
    <drug_datum>
      <drug_sequence>1007591665</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>IBUPROFEN</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number>017463</nda_number>
      <drug_indication indication_preferred_term="SWELLING
"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1007591666</drug_sequence>
      <role_code>I</role_code>
      <drug_name>CHANTIX</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1007591667</drug_sequence>
      <role_code>I</role_code>
      <drug_name>CHANTIX</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1007591668</drug_sequence>
      <role_code>I</role_code>
      <drug_name>CHANTIX</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="SMOKING CESSATION THERAPY
"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1007591669</drug_sequence>
      <role_code>I</role_code>
      <drug_name>PROVIGIL</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="NARCOLEPSY
"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1007591670</drug_sequence>
      <role_code>I</role_code>
      <drug_name>NORCO</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="NECK PAIN
"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1007591671</drug_sequence>
      <role_code>C</role_code>
      <drug_name>UNSPECIFIED MEDICATIONS</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="DRUG USE FOR UNKNOWN INDICATION
"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1007591672</drug_sequence>
      <role_code>C</role_code>
      <drug_name>UNSPECIFIED STOOL SOFTENER</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="CONSTIPATION
"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1007591673</drug_sequence>
      <role_code>C</role_code>
      <drug_name>CORRECTOL</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="CONSTIPATION
"/>
    </drug_datum>
  </adverse_event_report>
</adverse_event_case>
