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Oxycodone/acetaminophen presents a risk of abuse and addiction, potentially leading to overdose and death. It can also cause severe and possibly fatal breathing problems. To minimize these risks, it is important to adhere to the smallest effective dose for the shortest duration. Consult your doctor or pharmacist about keeping naloxone available to counteract an opioid overdose. Educate your family or household members on recognizing the signs of an opioid overdose and administering treatment.

Important safety considerations include:

• The likelihood of severe breathing problems increases when starting this medication, following a dosage increase, or if an incorrect dose/strength is taken.
• Combining this medication with alcohol or other substances that induce drowsiness or respiratory issues may result in serious side effects, including death.
• Certain medications can alter the removal of oxycodone/acetaminophen from the body, impacting its effectiveness. Understand how to take this medication and which other drugs to avoid.
• Seek immediate medical assistance if you experience slow or shallow breathing, unusual lightheadedness, severe drowsiness or dizziness, or difficulty waking up.
• Secure this medication to prevent theft, misuse, or abuse. If ingestion occurs accidentally, obtain medical help promptly.

Acetaminophen, an ingredient in this product, may cause serious liver damage if taken in excess. Adults should not exceed 4000 milligrams (4 grams) of acetaminophen daily. Those with liver conditions and children need to take a reduced amount. Consult your doctor or pharmacist about the safe acetaminophen dosage.

• Avoid using any other medication containing acetaminophen without consulting your doctor or pharmacist, as it is present in many over-the-counter and prescription products (e.g., pain relievers or cold medications). Check medication labels for acetaminophen content, and ask a pharmacist if uncertain.
• If an acetaminophen overdose occurs, seek medical attention immediately, even if you feel well. Symptoms may include nausea, vomiting, loss of appetite, sweating, stomach or abdominal pain, extreme fatigue, yellowing eyes or skin, and dark urine.
• Refrain from alcohol consumption, as daily use, particularly with acetaminophen, may harm the liver.

For women of childbearing age, discuss the risks and benefits of using this medication with your doctor. Inform your doctor if you are pregnant or planning to become pregnant. During pregnancy, use should be limited to when absolutely necessary, as it might slightly increase birth defect risks if taken during the first two months. Long-term or high-dose use near delivery may harm the unborn child. Use the lowest effective dose for the shortest possible time. Babies born to mothers using this medication extensively may develop severe withdrawal symptoms. Contact a doctor immediately if your newborn exhibits persistent crying, slow or shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.

You might experience mild side effects such as nausea, vomiting, constipation, lightheadedness, dizziness, or drowsiness when taking this medication. These are common and may lessen as your body adjusts to the drug. To manage constipation, incorporate dietary fiber, drink plenty of water, and stay active. Consult a pharmacist if a laxative is necessary. To avoid dizziness or lightheadedness, rise slowly from sitting or lying down positions.

However, be aware of more serious side effects, which require immediate medical attention. These include sleep interruptions like sleep apnea, changes in mood or mental state, severe stomach pain, difficulty urinating, and signs of adrenal gland issues such as appetite loss, unusual tiredness, or weight loss. In urgent cases like fainting, seizures, slow or shallow breathing, or severe drowsiness, seek emergency help without delay.

Although a severe allergic reaction is rare, it is crucial to seek immediate medical attention if you experience symptoms such as rash, itching or swelling (especially of the face, tongue, or throat), severe dizziness, or trouble breathing. If you notice any side effects not mentioned here, consult your healthcare provider.