hydromorphone hydrochloride 4 MG Oral Tablet
1 INDICATIONS AND USAGE Hydromorphone Hydrochloride Oral Solution and 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, which can occur at any dosage or duration [see Warnings and Precautions ( 5.2 )], reserve Hydromorphone Hydrochloride Oral Solution and 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 Oral Solution and Hydromorphone Hydrochloride Tablets 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. Hydromorphone Hydrochloride Tablets and Hydromorphone Hydrochloride Oral Solution 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 ( 5.2 ), reserve Hydromorphone Hydrochloride Tablets or Hydromorphone Hydrochloride Oral Solution 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 Oral Solution and Hydromorphone Hydrochloride Tablets 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.
West-Ward Pharmaceuticals Corp.
ROUND WHITE 54 196 4
54 196 4 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
HYDROMORPHONE HYDROCHLORIDE Oral Solution, USP 1 mg/mL oral solution is supplied as a clear, red solution. NDC 0054-0386-63: Bottle of 473 mL
HYDROMORPHONE HYDROCHLORIDE Tablets, USP 4 mg tablet is supplied as a white to off-white, round, flat-faced tablet with beveled edges; debossed with “4” on one side and “54 196” debossed on the other side. NDC 0054-0264-24: 10 x 10 Unit-Dose NDC 0054-0264-25: Bottle of 100 Tablets 8 mg tablet is supplied as a white to off-white, round, flat-faced tablet with beveled edges; scored on one side and “54 425” debossed on the other side. NDC 0054-0265-25: Bottle of 100 Tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF. Store
HYDROMORPHONE HYDROCHLORIDE Oral Solution and
HYDROMORPHONE HYDROCHLORIDE Tablets securely and dispose of properly .
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