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This medication contains codeine, which carries a risk of abuse and addiction that can potentially lead to overdose and death. Additionally, codeine may cause severe and possibly fatal breathing issues. To minimize these risks, it is important to follow your doctor's advice on taking the smallest effective dose for the shortest duration.

• Consider having naloxone available in case of opioid overdose; your doctor or pharmacist can advise you on this. Educate your family or household members on recognizing and responding to opioid overdose symptoms.
• The risk of serious breathing problems is heightened when you begin this medication, after a dosage increase, or if taken incorrectly. Combining this medicine with alcohol or other drugs that induce drowsiness or breathing issues can result in severe side effects, potentially leading to death.
• Be aware that certain medications can interfere with codeine metabolism, impacting its effectiveness. Ensure you understand the proper use of this medication and which drugs to avoid.
• Seek immediate medical attention if you experience critical side effects such as slow or shallow breathing, unusual lightheadedness, severe drowsiness, dizziness, or difficulty in waking up.
• Store this medication securely to prevent theft, misuse, or abuse. In case of accidental ingestion, seek medical help right away.

This product also includes acetaminophen, which, in excessive amounts, can cause severe liver issues, potentially fatal. Adults should not exceed 4000 milligrams (4 grams) per day, while those with liver problems and children should consume less. Consult your doctor or pharmacist for safe dosage guidelines.

• Avoid using other acetaminophen-containing products without medical advice. Many medications, both prescription and nonprescription, include acetaminophen—always check labels and consult your pharmacist if uncertain.
• Immediate medical assistance is necessary if you suspect an acetaminophen overdose, even if you feel fine, as symptoms might include nausea, vomiting, loss of appetite, sweating, stomach pain, extreme fatigue, yellowing of eyes/skin, and dark urine.
• Regular alcohol consumption, particularly with acetaminophen, may harm your liver, so it is advisable to avoid alcohol.

Women of childbearing age should discuss the medication's risks and benefits with their doctor. If you are pregnant or planning to become pregnant, inform your doctor. Use during pregnancy is recommended only if necessary, as it may slightly increase the risk of birth defects when taken in the first two months. Prolonged use or high doses near delivery can harm the unborn child. To reduce risks, take the minimum effective dose for the shortest period. Newborns exposed to this drug over a long term may experience serious withdrawal symptoms. Consult a doctor immediately if your newborn shows signs such as incessant crying, slow or shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or trouble gaining weight.

Children under 18 should not use codeine-containing products due to potential severe and rarely fatal breathing issues, particularly in those who are obese, have breathing problems, or have undergone certain surgeries (e.g., tonsil/adenoid removal). Discuss the risks and benefits with your doctor or pharmacist.

Common side effects:

• nausea
• vomiting
• abdominal pain
• tremors
• shortness of breath
• constipation
• dry mouth
• lightheadedness
• dizziness
• drowsiness
• trouble sleeping

Less common but important to monitor:

• sleep apnea
• mental or mood changes
• fast or irregular heartbeat
• increased thirst or urination
• persistent sore throat
• fever
• easy bruising or bleeding
• difficulty urinating
• loss of appetite
• unusual tiredness
• weight loss

Serious side effects:

• fainting
• seizures
• slow or shallow breathing
• severe drowsiness
• difficulty waking
• confusion
• rash
• itching
• swelling of the face, tongue, or throat
• severe dizziness
• trouble breathing

Interactions with high risk of serious adverse effects and should be avoided:

• opioid pain medications or cough suppressants (such as morphine or hydrocodone)
• alcohol
• marijuana (cannabis)
• sleep or anxiety medications (such as Alprazolam, Lorazepam, Zolpidem)
• muscle relaxants (like Carisoprodol, Cyclobenzaprine)
• antihistamines (such as Cetirizine, diphenhydramine)
• sodium oxybate

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Darunavir
• Isoniazid
• Lithium
• methoxyflurane
• Naltrexone
• various pain relievers (like morphine, Nalbuphine, pentazocine)
• phenothiazines (such as Chlorpromazine)
• samidorphan
• azole antifungals (such as Ketoconazole)
• bupropion
• Fluoxetine
• macrolide antibiotics (like Erythromycin)
• levoketoconazole
• paroxetine
• quinidine
• rifamycins (such as Rifabutin, Rifampin)
• Ritonavir
• some seizure medications (such as Carbamazepine, Phenytoin)

Interactions with low risk that usually do not require a change in therapy:

• doxycycline
• estrogen
• felodipine
• lonafarnib
• rilpivirine
• Tamoxifen
• Theophylline
• blood thinners (like Warfarin)
• certain beta blockers (such as metoprolol)
• corticosteroids (such as Prednisone)
• Caffeine