Aspirin/Butalbital/Caffeine/Codeine Oral Capsule (CODEINE/BUTALBITAL/ASPIRIN/CAFFEINE - ORAL)

Instructions

Sit or stand upright for 10 minutes after taking the medicine. Do not lie down.

Swallow with a full glass (8 oz) of water unless your doctor gives you different instructions.

You may take with food to prevent stomach upset.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

To reduce constipation, eat high fiber foods, drink plenty of water and exercise.

Avoid drinks with caffeine while on this medicine.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Talk to your doctor before taking other medicines, including aspirins and ibuprofen containing products. Speak to your doctor about which medicines are safe to use while you are on this medicine.

If you have diabetes and use urine glucose tests, this medicine may cause incorrect results. Please check with your doctor before making any changes to your diabetes treatment plan.

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.

Keep all appointments for medical exams and tests 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.

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

This medicine may cause bleeding from the stomach or bowels. Stop this medicine and call your doctor right away if you have pain in the stomach, red or dark tarry stools, or vomit that looks like coffee grounds.

Do not use the medication any more than instructed.

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

If possible, avoid using with alcohol, marijuana, or other medicines that can cause dizziness or drowsiness. These include allergy/cold products, muscle relaxers, sleep aids, and pain relievers.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Avoid smoking while on this medicine. Smoking may increase your risk for stomach bleeding.

Do not breastfeed while on this medicine. This medicine can pass through breast milk to the baby.

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.

Use medicine with caution if you have breathing problems. Get help right away for slow or shallow breathing.

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

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

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.

• agitated feeling or trouble sleeping
• bloating
• constipation
• dizziness or drowsiness
• dry mouth
• lightheadedness
• muscle trembling
• nausea
• stomach upset or abdominal pain

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

• severe or persistent abdominal pain
• decreased appetite
• increased risk of bruising and bleeding
• breathing interruption during sleep
• shallow, irregular breathing
• confusion
• coughing up blood or vomit that looks like coffee grounds
• fainting
• fever
• fast or irregular heart beats
• mood changes
• ringing in the ears
• seizures
• slurred speech
• dark, tarry stool
• difficulty swallowing
• swelling in the neck or throat
• excessive thirst
• unusual or unexplained tiredness or weakness
• increased urinary frequency
• dark urine
• weakness on one side of the body
• weight loss
• yellowing of eyes or skin

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.