oxycodone hydrochloride 5 mg
1 INDICATIONS AND USAGE Oxycodone hydrochloride (HCl) 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 (5.1) ] , reserve oxycodone HCl 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. Oxycodone HCl 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. Oxycodone HCl tablets are 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 oxycodone HCl tablets 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. Oxycodone HCl 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.
Amneal Pharmaceuticals LLC
ROUND WHITE A 04
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16 HOW SUPPLIED/STORAGE AND HANDLING
OXYCODONE HCl tablets, USP 5 mg are supplied as white, round, biconvex tablets debossed with “A” on the left and “04” on the right of the score on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-047-03 Bottles of 100: NDC 65162-047-10 Bottles of 250: NDC 65162-047-25 Bottles of 500: NDC 65162-047-50
OXYCODONE HCl tablets, USP 10 mg are supplied as pink, round, biconvex tablets debossed with “A” on the left and “48” on the right of the score on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-048-03 Bottles of 100: NDC 65162-048-10 Bottles of 250: NDC 65162-048-25
OXYCODONE HCl tablets, USP 15 mg are supplied as green, round, biconvex tablets debossed with “A” on the left and “49” on the right of the score on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-049-03 Bottles of 100: NDC 65162-049-10 Bottles of 250: NDC 65162-049-25 Bottles of 500: NDC 65162-049-50
OXYCODONE HCl tablets, USP 20 mg are supplied as gray, round, biconvex tablets debossed with “A” on the left and “50” on the right of the score on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-050-03 Bottles of 100: NDC 65162-050-10 Bottles of 250: NDC 65162-050-25
OXYCODONE HCl tablets, USP 30 mg are supplied as blue, round, biconvex tablets debossed with “A” on the left and “51” on the right of the score on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-051-03 Bottles of 100: NDC 65162-051-10 Bottles of 250: NDC 65162-051-25 Bottles of 500: NDC 65162-051-50 DEA Order Form Required. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Protect from moisture. Store at 20° to 25°C (68° to 77°F); excursions are permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store
OXYCODONE HCl securely and dispose of properly [see Patient Counseling Information (17) ] .
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