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Hydromorphone Hydrochloride 2 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. Hydromorphone Hydrochloride Oral Solution and 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, even at recommended doses, reserve hydromorphone hydrochloride oral solution or 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 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 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

Rhodes Pharmaceuticals L.P.


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6 years ago ROUND ORANGE P 2 Hydromorphone Hydrochloride 2 MG Oral Tablet

ROUND ORANGE P 2

6 years ago ROUND ORANGE P 2 Hydromorphone Hydrochloride 2 MG Oral Tablet

P 2 ROUND ORANGE

16 HOW SUPPLIED/STORAGE AND HANDLING

HYDROMORPHONE HYDROCHLORIDE is available as follows: Oral Solution 5 mg/5 mL : a clear, colorless to pale yellow, slightly viscous liquid. NDC 42858-304-16: Bottles of 1 pint (473 mL) 2 mg Tablets: light orange, round, flat-faced tablets, with beveled edges, debossed with a "P" on one side and the number "2" on the opposite side. NDC 42858-301-01: Bottles of 100 NDC 42858-301-25: Unit Dose Packages of 100 (4×25) 4 mg Tablets : light yellow, round, flat-faced tablets, with beveled edges, debossed with a "P" on one side and the number "4" on the opposite side. NDC 42858-302-01: Bottles of 100 NDC 42858-302-25: Unit Dose Packages of 100 (4×25) NDC 42858-302-50: Bottles of 500 8 mg Tablets : white, triangular shaped tablets debossed with a "P" and an inverted "P" separated with a bisect on one side of the tablet and debossed with the number "8" on the other side of the tablet. NDC 42858-303-01: Bottles of 100 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Store

HYDROMORPHONE HYDROCHLORIDE oral solution or

HYDROMORPHONE HYDROCHLORIDE tablets securely and dispose of properly [see Patient Counseling Information (17) ] .

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