| Document Date: 2014-04-29 17:23:15
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City Reference / / Company Unused SUBOXONE Sublingual Films / Reckitt Benckiser Pharmaceuticals Inc. / / Event Product Issues / Product Recall / FDA Phase / / Facility Store SUBOXONE / / IndustryTerm buprenorphine sublingual solutions / short-acting opioid products / buprenorphine sublingual solution / machinery / hazardous machinery / buprenorphine ethanolic sublingual solution / buprenorphine products / buprenorphine ethanolic solution / administered product / fixed-dose combination product / combination product / on short-acting opioid products / fixed combination product / combination products / buprenorphine product / long-acting opioid products / / MedicalCondition glossodynia / oral mucosal erythema / anaphylactic shock / myoclonus / oral hypoesthesia / 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 / 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 / vomiting / pain / acute withdrawal symptoms / hypertonia / neonatal tremor / fatal / respiratory depression / acute alcoholism / myxedema / hepatic failure / Allergic Reactions / Drug Abuse / significant respiratory depression / respiratory depression / infection / delirium tremens / opioid withdrawal syndrome / miosis / angioneurotic edema / cor pulmonale / / MedicalTreatment counseling / psychotherapy / pharmacotherapy / / Organization Chronic administration / DOSAGE AND ADMINISTRATION / FDA / / / Position Secretary of Health / pharmacist / physician / General / / Product symptoms / Neonatal Withdrawal Neonatal / signs / SUBUTEX / Neonatal / Sublingual Tablets / Use / naloxone / SUBOXONE / opioid / syndrome / 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 SUBOXONE safely and effectively. See full prescribing information for SUBOXONE. SUBOXONE® (buprenorphine and naloxo