Oxycodone Hydrochloride 15 MG Oral Tablet Roxicodone

1 INDICATIONS AND USAGE ROXICODONE is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions ( 5.1 )] , reserve ROXICODONE for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia. ROXICODONE should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. ROXICODONE is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, reserve ROXICODONE for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or non-opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia. ROXICODONE should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

specgx llc

FDA Reported Adverse Reactions
`[1] pain` `[2] drug ineffective` `[3] drug dependence` `[4] fatigue` `[5] death` `[6] nausea` `[7] overdose` `[8] dyspnoea` `[9] toxicity to various agents` `[10] off label use`

3 years ago

ROUND GREEN 54 710

16 HOW SUPPLIED/STORAGE AND HANDLING ROXICODONE ® (

OXYCODONE HYDROCHLORIDE tablets USP) are available as follows: 15 mg green tablets scored (Identified 54 710) [Embossed 54 710 on one side] NDC 23635-581-10: Bottles of 100 tablets 30 mg blue tablets scored (Identified 54 199) [Embossed 54 199 on one side] NDC 23635-582-10: Bottles of 100 tablets Dispense in a tight, light-resistant container. Protect from moisture. Store at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store ROXICODONE securely and dispose of properly [see Patient Counseling Information ( 17 )] .

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