oxycodone 7.5 mg acetaminophen 325 mg

INDICATIONS AND USAGE Oxycodone and acetaminophen tablets is 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): • 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.

Alvogen, Inc.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] pain` `[4] dyspnoea` `[5] nausea` `[6] arthralgia` `[7] headache` `[8] diarrhoea` `[9] off label use` `[10] pyrexia`

4 years ago

ROUND ORANGE LOGO 229

4 years ago

LOGO 229 ROUND ORANGE

HOW SUPPLIED

OXYCODONE AND ACETAMINOPHEN Tablets, USP are supplied as follows:

OXYCODONE AND ACETAMINOPHEN Tablets, USP 5 mg/325 mg blue, round tablet, debossed with "ALV" over "196", separated by a bisect, on one side, and plain on the other side. Bottles of 100 NDC 47781-196-01 Bottles of 250 NDC 47781-196-63 Bottles of 500 NDC 47781-196-05

OXYCODONE AND ACETAMINOPHEN Tablets, USP 7.5 mg/325 mg orange to yellow, round tablet, debossed with “229” on one side and “ ”on the other side. Bottles of 100 NDC 47781-229-01 Bottles of 250 NDC 47781-229-63 Bottles of 500 NDC 47781-229-05

OXYCODONE AND ACETAMINOPHEN Tablets, USP 10 mg/325 mg yellow, round tablet, debossed with “230” on one side and “ ” on the other side. Bottles of 100 NDC 47781-230-01 Bottles of 250 NDC 47781-230-63 Bottles of 500 NDC 47781-230-05 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, USP securely and dispose of properly [see PRECAUTIONS ; I nformation for Patients and/or Caregivers ] .

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