Acetaminophen/Butalbital/Caffeine/Codeine Oral Capsule (CODEINE/BUTALBITAL/ACETAMINOPHEN/CAFFEINE - ORAL)

Instructions

This medicine may be taken with or without food.

Keep the medicine at room temperature. Avoid heat and direct light.

Tell your doctor and pharmacist about all your medicines. Include prescription and over-the-counter medicines, vitamins, and herbal medicines.

This medicine may decrease the effectiveness of some birth controls which use hormones (such as birth control pills and patches). Use an extra form of birth control, such as condoms, while on this medicine.

Cautions

Do not use in children younger than 18. Some children using this medicine had serious side effects or died. Ask your doctor about the risks and benefits of this medicine.

This medicine has an opioid. Opioids help many people but may cause addiction, especially if used for a long time. The addiction risk is higher if you have a substance use disorder (overuse of or addiction to drugs or alcohol). Ask your doctor about the benefits and risks.

Ask your doctor or pharmacist if you should have naloxone on hand to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.

If you stop this medicine suddenly after using it for a long time, you may have withdrawal. Your doctor may slowly lower your dose before stopping it. Tell your doctor right away if you have symptoms, such as unusual sweating, watering eyes, runny nose, chills, diarrhea, yawning, muscle aches, restlessness, anxiety, trouble sleeping, or thoughts of suicide.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Do not use the medication any more than instructed.

This medicine may cause dizziness or fainting. Do not stand or sit up quickly.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not operate machinery or drive while on this medicine.

Do not drink beverages with alcohol while on this medicine.

This medicine passes into breast milk. Ask your doctor before breastfeeding.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Do not start or stop any other medicines without first speaking to your doctor or pharmacist.

Call your doctor right away if you notice slow or shallow breathing.

Do not share this medicine with anyone who has not been prescribed this medicine.

This medicine has acetaminophen. Many medicines have acetaminophen. Taking them together can cause you to get too much acetaminophen, which can cause serious liver problems. Read all medicine labels for acetaminophen. Ask your pharmacist which medicines you can take safely.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• constipation
• dizziness or drowsiness
• dry mouth
• nausea and vomiting
• shortness of breath
• stomach upset or abdominal pain

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• decreased appetite
• breathing interruption during sleep
• shallow, irregular breathing
• changes in memory, mood, or thinking
• depression or feeling sad
• lack of energy and tiredness
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.