| Document Date: 2014-12-16 14:31:45
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City Reference / / Company Reckitt Benckiser Pharmaceuticals Inc. / / Event Product Issues / Product Recall / / Facility Store SUBUTEX / / IndustryTerm buprenorphine sublingual solutions / machinery / mg solution / hazardous machinery / sublingual solution / buprenorphine products / buprenorphine solution / monitor for signs and symptoms / / MedicalCondition anaphylactic shock / myoclonus / headache / CNS Depression / neonatal withdrawal syndrome / hives / cytolytic hepatitis / coma / dysfunction / apnea / respiratory depression / nausea / prostatic hypertrophy / hepatitis C / hepatitis B / hyperhidrosis / hepatic necrosis / withdrawal syndrome / bradycardia / hypersensitivity / Addison's disease / Diarrhea / Hepatitis / constipation / pruritus / hepatorenal syndrome / Whole Abscess / Flu Syndrome / head injury / insomnia / toxic psychoses / bronchospasm / urethral stricture / hypothyroidism / Chills / Carcinogenesis / chronic obstructive pulmonary disease / acute hepatitis / hepatic encephalopathy / increased CNS depression / chronic administration / Orthostatic Hypotension / pain / vomiting / hypertonia / neonatal tremor / fatal / respiratory depression / acute alcoholism / myxedema / hepatic failure / Allergic Reactions / Drug Abuse / significant respiratory depression / respiratory depression / infection / delirium tremens / Dizziness / opioid withdrawal syndrome / Depression / miosis / cor pulmonale / / MedicalTreatment counseling / psychotherapy / pharmacotherapy / / Organization Chronic administration / DOSAGE AND ADMINISTRATION / FDA / / / Position Secretary of Health / physician / General / / Product Neonatal Withdrawal Neonatal / signs / SUBUTEX / Neonatal / General Precautions SUBUTEX / Administer SUBUTEX / Sublingual Tablets / Use / naloxone / SUBOXONE / Opioid / syndrome / Operate Machinery SUBUTEX / Store SUBUTEX / machinery / Hepatic Function / / Technology drug screening / Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SUBUTEX® sublingual tablet safely and effectively. See full prescribing information for SUBUTEX sublingual tablet.