Medication Guide

Oxycodone (ox" i koe' done) and Acetaminophen (a seet" a min' oh fen) Tablets, CII

Oxycodone and Acetaminophen Tablets are:

• A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate and when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
• An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Important information about Oxycodone and Acetaminophen Tablets :

• Get emergency help or call 911 right away if you take too much oxycodone and acetaminophen tablets (overdose). When you first start taking oxycodone and acetaminophen tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.
• Taking oxycodone and acetaminophen tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
• Never give anyone else your oxycodone and acetaminophen tablets. They could die from taking it. Selling or giving away oxycodone and acetaminophen tablets is against the law.
• Store oxycodone and acetaminophen tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not take Oxycodone and Acetaminophen Tablets if you have :

• Severe asthma, trouble breathing, or other lung problems.
• A bowel blockage or have narrowing of the stomach or intestines
• known hypersensitivity to oxycodone, acetaminophen, or any ingredient in oxycodone and acetaminophen tablets

Before  taking Oxycodone and Acetaminophen Tablets, tell your healthcare provider if you have a history of :

• Head injury, seizures
• Liver, kidney, thyroid problems
• Problems urinating
• Pancreas or gallbladder problems
• Abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems

Tell your healthcare provider if you are:

• Noticing your pain getting worse. If your pain gets worse after you take oxycodone and acetaminophen tablets, do not take more of oxycodone and acetaminophen tablets without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking oxycodone and acetaminophen tablets.
• Are pregnant or planning to become pregnant. Use of oxycodone and acetaminophen tablets for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if notrecognized and treated.
• Breastfeeding.  Oxycodone and acetaminophen passes into breast milk and may harm your baby. Carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Seek immediate medical care if you notice these signs.
• Living in a household where there are small children or someone who has abused street or prescription drugs.
• Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking oxycodone and acetaminophen tablets with certain other medicines can cause serious side effects that could lead to death.

When taking Oxycodone and Acetaminophen Tablets :

• Do not change your dose. Take oxycodone and acetaminophen tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• For acute (short-term) pain, you may only need to take oxycodone and acetaminophen tablets for a few days. You may have some oxycodone and acetaminophen tablets left over that you did not use. See disposal information at the bottom of this section for directions on how to safely throw away (dispose of) your unused oxycodone and acetaminophen tablets.
• Take your prescribed dose every 6 hours as needed for pain. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
• Call your healthcare provider if the dose you are taking does not control your pain.
• If you have been taking oxycodone and acetaminophen tablets regularly, do not stop taking oxycodone and acetaminophen tablets without talking to your healthcare provider.
• Dispose of expired, unwanted, or unused oxycodone and acetaminophen tablets by taking your drug to an authorized DEA-registered collector or drug take-back program. If one is not available, you can dispose of oxycodone and acetaminophen tablets by mixing the product with dirt, cat litter, or coffee grounds; placing the mixture in a sealed plastic bag, and throwing the bag in your trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While taking Oxycodone and Acetaminophen Tablets DO NOT:

• Drive or operate heavy machinery, until you know how oxycodone and acetaminophen tablets affects you. Oxycodone and acetaminophen tablets can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with oxycodone and acetaminophen tablets may cause you to overdose and die.

The possible side effects of Oxycodone and Acetaminophen Tablets:

• Constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

• Trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of oxycodone and acetaminophen tablets. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov. or call 1-866-770-3024.

Made in USA

Manufactured by:
Norwich Pharmaceuticals, Inc.
6826 State Highway 12
Norwich, NY 13815 USA

Distributed by:
Alvogen, Inc.
Morristown, NJ 07960 USA

This Medication Guide has been approved by the U.S. Food and Drug Administration.

PL229-07
Revised: 12/2023