Hydromorphone Hydrochloride 8 MG Oral Tablet
1 INDICATIONS & USAGE Hydromorphone Hydrochloride Tablets are 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, even at recommended doses [see Warnings and Precautions ( 5.2 )], reserve Hydromorphone Hydrochloride Tablets 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 Hydromorphone Hydrochloride Tablets contain hydromorphone, an opioid agonist, and are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, reserve Hydromorphone Hydrochloride Tablets 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
aurolife pharma, llc
ROUND WHITE U46
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Aurolife Pharma, LLC
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16 HOW SUPPLIED/STORAGE AND HANDLING
HYDROMORPHONE HYDROCHLORIDE Tablets USP, 2 mg are light orange to orange colored, mottled, round, flat-faced beveled edge tablets debossed with 'U' on one side and '44' on the other side. Bottles of 20 NDC 13107-107-20 Bottles of 100 NDC 13107-107-01 Bottles of 500 NDC 13107-107-05 Bottles of 1000 NDC 13107-107-99
HYDROMORPHONE HYDROCHLORIDE Tablets USP, 4 mg are light yellow to yellow colored, round, flat-faced beveled edge tablets debossed with 'U' on one side and '45' on the other side. Bottles of 20 NDC 13107-108-20 Bottles of 100 NDC 13107-108-01 Bottles of 500 NDC 13107-108-05 Bottles of 1000 NDC 13107-108-99
HYDROMORPHONE HYDROCHLORIDE Tablets USP, 8 mg are white to off-white, round, flat-faced beveled edge tablets debossed with 'U46' on one side and bisect on the other side. Bottles of 20 NDC 13107-109-20 Bottles of 100 NDC 13107-109-01 Bottles of 500 NDC 13107-109-05 Bottles of 1000 NDC 13107-109-99 Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. Protect from light. Store
HYDROMORPHONE HYDROCHLORIDE Tablets securely and dispose of properly [see Patient Counseling Information (17)]. A Schedule CS-II Narcotic. DEA Order Form is required. Trademarks are the property of their respective owners.
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