Oxycodone Acetaminophen 10-325 100 Tablets

3 31722–194–01 3
N
Lot:
Exp:
NO VARNISH
Rev. 02/17

CAMBER (logo)

NDC 31722-194-01

Oxycodone and Acetaminophen Tablets, USP

10 mg / 325 mg*

(CII symbol)

Multiple Strengths: Do not dispense unless strength is stated.
Dispense the enclosed Medication Guide to each patient.

Rx Only
100 Tablets

Each tablet contains:
Oxycodone Hydrochloride, USP…10 mg*
Acetaminophen, USP………………325 mg
*10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone.

Usual Dosage: See package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F).
[see USP Controlled Room Temperature]

Dispense in tight, light-resistant container as defined in the USP with a child-resistant closure.

DEA ORDER FORM REQUIRED.

Manufactured for:
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854

Manufactured by:
Ascent Pharmaceuticals, Inc.
Central Islip, NY 11722

Key Information

• Active Ingredients: Each tablet contains 10 milligrams (mg) of oxycodone hydrochloride and 325 mg of acetaminophen.
• Purpose: It is used to treat pain severe enough to require an opioid, which works in the brain to change how the body feels and responds to pain. Acetaminophen also helps reduce pain and fever.

• Dosage: The usual adult dose is one tablet every 6 hours as needed for pain, not to exceed a total daily dose of 4000 mg of acetaminophen from all sources. Your doctor may adjust the dose based on your response.

• Form: The 10 mg/325 mg tablet is typically a white to off-white, caplet-shaped tablet with “M523” on one side and “10/325” on the other, depending on the manufacturer.

Important Warnings and Precautions

• Addiction and Abuse: This medication carries a boxed warning from the FDA regarding the serious risks of addiction, abuse, and misuse, which can lead to overdose and death.
• Respiratory Depression: Serious, life-threatening respiratory depression can occur, especially when starting the medication or increasing the dose.
• Liver Damage: Acetaminophen has been associated with cases of acute liver failure. Do not exceed the maximum daily dose of acetaminophen (4000 mg/day) and avoid alcohol while taking this medication.

• Interactions: Concomitant use with benzodiazepines, alcohol, or other central nervous system (CNS) depressants can result in profound sedation, respiratory depression, coma, and death.
• Accidental Ingestion: Stored securely, out of sight and reach of children, as accidental ingestion of even one dose can be fatal to a child. 
• Always consult with a healthcare professional for proper dosing, risks, and disposal instructions for this medication.

What pain types is this combination medication prescribed for?

The oxycodone-acetaminophen 10 mg/325 mg combination is prescribed for managing moderate to severe pain that requires an opioid and for which alternative treatments are inadequate.

• Acute Postoperative Pain (pain after surgery)
• Post-traumatic pain
• Cancer-related Pain
• Osteoarthritis and Rheumatoid Arthritis pain
• Chronic Low Back Pain
• Breakthrough Pain (sudden pain that occurs despite ongoing pain treatment)