Oxycodone and Acetaminophen Acetaminophen 325 MG Oxycodone Hydrochloride 7.5 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, even at recommended doses [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

Actavis Elizabeth LLC

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

7 years ago

OVAL WHITE A332

HOW SUPPLIED Oxycodone and acetaminophen tablets, USP are available as follows: 2.5 mg/325 mg –white to off-white, oval tablets, debossed “A331” on one side and plain on the other side. Tablets are supplied in bottles of 100 (NDC 0228-2980-11) with child-resistant closure. 5 mg/325 mg – white to off-white, round tablets, debossed “A349” on bisected side and plain on the other side. Tablets are supplied in bottles of 100 (NDC 0228-2981-11) with child-resistant closure, and 500 (NDC 0228-2981-50) without a child-resistant closure. 7.5 mg/325 mg – white to off-white, capsule-shaped tablets, debossed “A332” on one side and plain on the other side. Tablets are supplied in bottles of 100 (NDC 0228-2982-11) with child-resistant closure. 10 mg/325 mg – white to off-white, modified capsule-shaped tablets, debossed “A333” on one side and plain on the other side. Tablets are supplied in bottles of 100 (NDC 0228-2983-11) with child-resistant closure, and 500 (NDC 0228-2983-50) without a child-resistant closure. 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, with a child-resistant closure (as required). Store Oxycodone and Acetaminophen Tablets, USP securely and dispose of properly [see PRECAUTIONS ; Information for Patients/Caregiver ]. Manufactured by: Warner Chilcott Company, LLC Manati, Puerto Rico 00674 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. D 8/2019

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