Acetaminophen 325 MG Oxycodone Hydrochloride 2.5 MG Oral Tablet

INDICATIONS AND USAGE Oxycodone and Acetaminophen 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, 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.

camber pharmaceuticals, inc.

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

4 years ago

OVAL WHITE T191

HOW SUPPLIED

OXYCODONE AND ACETAMINOPHEN Tablets, USP are supplied as follows: 2.5 mg/325 mg white to off-white color capsule shaped tablets debossed with ‘T 191’ on one side and plain on other side. Bottles of 100 NDC 31722-948-01 Bottles of 500 NDC 31722-948-05 5 mg/325 mg white to off-white color round, biconvex tablets having break line on one side and debossed with ‘T 192’ on other side. Bottles of 100 NDC 31722-949-01 Bottles of 500 NDC 31722-949-05 7.5 mg/325 mg white to off-white color capsule shaped tablets debossed with ‘T 193’ on one side and plain on other side. Bottles of 100 NDC 31722-950-01 Bottles of 500 NDC 31722-950-05 10 mg/325 mg white to off-white color capsule shaped tablets debossed with ‘T 194’ on one side and plain on other side. Bottles of 100 NDC 31722-951-01 Bottles of 500 NDC 31722-951-05 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]. Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722 Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Rev: 02/24

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camber pharmaceuticals inc

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