Instructions

This medicine may be taken with or without food.

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.

You may stop using this medicine if you no longer have symptoms.

Keep all appointments for medical exams and tests while on this medicine.

Do not take the medicine more than five times during 24 hours.

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.

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.

Call the doctor if there are any signs of confusion or unusual changes in behavior.

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.

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.

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.

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
• constipation
• dizziness or drowsiness
• headaches
• lightheadedness
• nausea and vomiting
• increased urinary frequency

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

• abdominal cramps
• decreased appetite
• breathing interruption during sleep
• confusion
• fainting
• hallucinations (unusual thoughts, seeing or hearing things that are not real)
• fast or irregular heart beats
• irritability
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• mood changes
• nervousness
• seizures
• shakiness
• stomach pain
• difficulty or discomfort urinating
• blurring or changes of vision
• weight loss

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.