oxycodone hydrochloride tablet
1 INDICATIONS AND USAGE Oxycodone 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 ( 5.1 )] , reserve oxycodone 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. Oxycodone hydrochloride 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 ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve oxycodone hydrochloride 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.
KVK-TECH,INC
ROUND GREEN K 8
K 8 ROUND GREEN
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16 HOW SUPPLIED/STORAGE AND HANDLING
OXYCODONE HYDROCHLORIDE tablets, USP are available as follows:
OXYCODONE HYDROCHLORIDE tablets, USP 5 mg are supplied as white round biconvex tablets debossed "K" on left and "18" on right of the bisect on one side and plain on the other side. NDC 10702-018-01 Bottles of 100 tablets NDC 10702-018-50 Bottles of 500 tablets
OXYCODONE HYDROCHLORIDE tablets, USP 10 mg are supplied as pink round biconvex tablets debossed "K" on left and "56" on right of the bisect on one side and plain on the other side. NDC 10702-056-01 Bottles of 100 tablets NDC 10702-056-50 Bottles of 500 tablets
OXYCODONE HYDROCHLORIDE tablets, USP 15 mg are supplied as green round biconvex tablets debossed "K" on left and "8" on right of the bisect on one side and plain on the other side. NDC 10702-008-01 Bottles of 100 tablets NDC 10702-008-50 Bottles of 500 tablets
OXYCODONE HYDROCHLORIDE tablets, USP 20 mg are supplied as gray round biconvex tablets debossed "K" on left and "57" on right of the bisect on one side and plain on the other side. NDC 10702-057-01 Bottles of 100 tablets NDC 10702-057-50 Bottles of 500 tablets
OXYCODONE HYDROCHLORIDE tablets, USP 30 mg are supplied as blue round biconvex tablets debossed "K" on left and "9" on right of the bisect on one side and plain on the other side. NDC 10702-009-01 Bottles of 100 tablets NDC 10702-009-50 Bottles of 500 tablets Dispense in a tight, light-resistant container. Protect from moisture. Store at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
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