Acetaminophen 325 MG Oxycodone Hydrochloride 5 MG Oral Tablet Roxicet

INDICATIONS AND USAGE ROXICET is indicated for the relief of moderate to moderately severe pain.

West-Ward Pharmaceuticals Corp

FDA Reported Adverse Reactions
`[1] fatigue` `[2] dyspnoea` `[3] drug ineffective` `[4] pain` `[5] dizziness` `[6] nausea` `[7] hypotension` `[8] headache` `[9] death` `[10] cough`

5 years ago

ROUND WHITE 54 543

5 years ago

54 543 ROUND WHITE

HOW SUPPLIED ROXICET™ Tablets, Oxycodone and Acetaminophen Tablets USP (Oxycodone Hydrochloride 5 mg and Acetaminophen 325 mg) white, round, scored tablets (Identified 54 543) NDC 0054-8650-24: Unit dose, 25 tablets per card (reverse numbered), 4 cards per shipper. NDC 0054-4650-25: Bottles of 100 tablets. NDC 0054-4650-29: Bottles of 500 tablets. 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/NF. ROXICET™ Oral Solution, Oxycodone and Acetaminophen Oral Solution (Oxycodone Hydrochloride 5 mg and Acetaminophen 325 mg Oral Solution per 5 mL) Clear, dark red solution NDC 0054-8648-16: Unit dose Patient Cups™ filled to deliver 5 mL (Oxycodone Hydrochloride 5 mg, Acetaminophen 325 mg), ten 5 mL Patient Cups™ per shelf pack, four shelf packs per shipper. NDC 0054-3686-63: Bottles of 500 mL. Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP/NF. DEA Order Form Required. 4073402//06 Revised October 2013 ©RLI, 2013

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west-ward pharmaceuticals corp

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