OxyContin 12 HR Oxycodone Hydrochloride 80 MG Extended Release Oral Tablet Oxycontin
1 INDICATIONS AND USAGE OXYCONTIN is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate in: Adults; and Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions ( 5.1 )] , reserve OXYCONTIN for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. OXYCONTIN is not indicated as an as-needed (prn) analgesic. OXYCONTIN is an opioid agonist indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate in:( 1 ) Adults; and Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent. Limitations of Use ( 1 ) Because of the risks of addiction, abuse and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, reserve OXYCONTIN for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. OXYCONTIN is not indicated as an as-needed (prn) analgesic.
Purdue Pharma LP
ROUND GREEN OP 80
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16 HOW SUPPLIED/STORAGE AND HANDLING OXYCONTIN (
OXYCODONE HYDROCHLORIDE) extended-release tablets 10 mg are film-coated, round, white-colored, bi-convex tablets debossed with OP on one side and 10 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 ( NDC 59011-410-10 ) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton ( NDC 59011-410-20 ). OXYCONTIN (
OXYCODONE HYDROCHLORIDE) extended-release tablets 15 mg are film-coated, round, gray-colored, bi-convex tablets debossed with OP on one side and 15 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 ( NDC 59011-415-10 ) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton ( NDC 59011-415-20 ). OXYCONTIN (
OXYCODONE HYDROCHLORIDE) extended-release tablets 20 mg are film-coated, round, pink-colored, bi-convex tablets debossed with OP on one side and 20 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 ( NDC 59011-420-10 ) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton ( NDC 59011-420-20 ). OXYCONTIN (
OXYCODONE HYDROCHLORIDE) extended-release tablets 30 mg are film-coated, round, brown-colored, bi-convex tablets debossed with OP on one side and 30 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 ( NDC 59011-430-10 ) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton ( NDC 59011-430-20 ). OXYCONTIN (
OXYCODONE HYDROCHLORIDE) extended-release tablets 40 mg are film-coated, round, yellow-colored, bi-convex tablets debossed with OP on one side and 40 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 ( NDC 59011-440-10 ) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton ( NDC 59011-440-20 ). OXYCONTIN (
OXYCODONE HYDROCHLORIDE) extended-release tablets 60 mg are film-coated, round, red-colored, bi-convex tablets debossed with OP on one side and 60 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 ( NDC 59011-460-10 ) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton ( NDC 59011-460-20 ). OXYCONTIN (
OXYCODONE HYDROCHLORIDE) extended-release tablets 80 mg are film-coated, round, green-colored, bi-convex tablets debossed with OP on one side and 80 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 ( NDC 59011-480-10 ) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton ( NDC 59011-480-20 ). Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Store OXYCONTIN securely and dispose of properly [see Patient Counseling Information ( 17 )] . Dispense in tight, light-resistant container.
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