12 HR Hydrocodone Bitartrate 50 MG Extended Release Oral Capsule Zohydro
1 INDICATIONS AND USAGE Hydrocodone Bitartrate Extended-Release Capsules is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hydrocodone Bitartrate Extended-Release Capsules is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Hydrocodone Bitartrate Extended-Release Capsules 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. ( 1 ) Hydrocodone Bitartrate Extended-Release Capsules is not indicated as an as-needed (prn) analgesic. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1) ] , reserve Hydrocodone Bitartrate Extended-Release Capsules 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. Hydrocodone Bitartrate Extended-Release Capsules is not indicated as an as-needed (prn) analgesic.
persion pharmaceuticals llc
CAPSULE BROWN Z350 50mg
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16 HOW SUPPLIED/STORAGE AND HANDLING Hydrocodone Bitartrate Extended-Release capsules are supplied in 60-count bottles with a child-resistant closure as follows: Strength capsule Color(s) capsule Text NDC Number 10 mg white opaque "Z310 10 mg" in black ink 65224-910-60 15 mg Light green and white opaque "Z315 15 mg" in black ink 65224-915-60 20 mg Light green opaque "Z320 20 mg" in black ink 65224-920-60 30 mg Dark blue and white opaque "Z330 30 mg" in black ink 65224-930-60 40 mg Dark brown and white opaque "Z340 40 mg" in black ink 65224-940-60 50 mg Dark brown opaque "Z350 50 mg" in black ink 65224-950-60 Hydrocodone Bitartrate Extended-Release capsules contains hydrocodone bitartrate which is a controlled substance and is controlled under Schedule II of the Controlled Substances Act. Hydrocodone, like all opioids, is liable to diversion and misuse and should be handled accordingly. Patients and their families should be instructed to dispose of any Hydrocodone Bitartrate Extended-Release capsules capsules that are no longer needed. Hydrocodone Bitartrate Extended-Release capsules may be targeted for theft and diversion. Healthcare professionals should contact their State Medical Board, State Board of Pharmacy, or State Control Board for information on how to detect or prevent diversion of this product. Healthcare professionals should advise patients to store Hydrocodone Bitartrate Extended-Release capsules in a secure place, preferably locked and out of the reach of children and other non-caregivers. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight container as defined in the USP, with a child-resistant closure. Advise patients to dispose of any unused capsules from a prescription as soon as they are no longer needed in accordance with local State guidelines and/or regulations [see Patient Counseling Information (17) ].
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