Oxycodone and Acetaminophen Acetaminophen 325 MG Oxycodone Hydrochloride 5 MG Oral Tablet
INDICATIONS AND USAGE Oxycodone and Acetaminophen Tablets, USP 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 ], reserve oxycodone and acetaminophen 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 and acetaminophen 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.
Rhodes Pharmaceuticals L.P.
ROUND WHITE 5 325 R P
5 325 R P ROUND WHITE
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Oxycodone and Acetaminophen Acetaminophen 325 MG Oxycodone Hydrochloride 5 MG Oral Tablet
Rhodes Pharmaceuticals L.P.
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HOW SUPPLIED
OXYCODONE AND ACETAMINOPHEN Tablets, USP is supplied as follows: 5 mg/325 mg white to off-white, round, biconvex tablet, debossed 5 over 325 on one side and R bisect P on the other side. Bottles of 100 tablets NDC 42858-102-01 Bottles of 500 tablets NDC 42858-102-50 Unit Dose Packages of 100 (10 tablets × 10 cards) NDC 42858-102-10 7.5 mg/325 mg white to off-white, round, biconvex tablet debossed 7.5 over 325 on one side and RP on the other side. Bottles of 100 tablets NDC 42858-103-01 Bottles of 500 tablets NDC 42858-103-50 Unit Dose Packages of 100 (10 tablets × 10 cards) NDC 42858-103-10 10 mg/325 mg white to off-white, round, biconvex tablet debossed 10 over 325 on one side and RP on the other side. Bottles of 100 tablets NDC 42858-104-01 Bottles of 500 tablets NDC 42858-104-50 Unit Dose Packages of 100 (10 tablets × 10 cards) NDC 42858-104-10 Storage Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP. Store
OXYCODONE AND ACETAMINOPHEN Tablets securely and dispose of properly [see PRECAUTIONS, Information for Patients/Caregivers ] .
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