Acetaminophen and codeine is a combination medicine used to relieve moderate to severe pain.

Acetaminophen and codeine may also be used for purposes not listed in this medication guide.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Do not give this medicine to anyone younger than 12 years old, or anyone under 18 who recently had surgery to remove the tonsils or adenoids.

Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

The combination of acetaminophen and codeine comes as a tablet, capsule, and liquid to take by mouth. It usually is taken every 4 hours as needed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take acetaminophen and codeine exactly as directed.

If you have taken acetaminophen and codeine for several weeks or longer, do not stop taking the medication without talking to your doctor. Your doctor may decrease your dose gradually. If you suddenly stop taking acetaminophen and codeine, you may experience withdrawal symptoms such as restlessness, widened pupils (black circles in the center of the eyes), teary eyes, irritability, anxiety, runny nose, difficulty falling asleep or staying asleep, yawning, sweating, fast breathing, fast heartbeat, chills, nausea, loss of appetite, vomiting, diarrhea, stomach cramps, or muscle aches.

Follow the directions on your prescription label and read all medication guides. Never use this medicine in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time that you are using this medicine.

Do not stop using acetaminophen and codeine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

You should not use acetaminophen and codeine if you are allergic to acetaminophen or codeine, or if you have:

• severe asthma or breathing problems; or

• a blockage in your stomach or intestines.

In some people, codeine breaks down rapidly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death.

Codeine is not approved for use by anyone younger than 12 years old.

Do not give this medicine to anyone younger than 18 years old who recently had surgery to remove the tonsils or adenoids.

Tell your doctor if you have ever had:

• breathing problems, sleep apnea;

• liver disease;

• alcoholism or drug addiction;

• urination problems;

• kidney disease; or

• problems with your pancreas, thyroid, or gallbladder.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Do not breastfeed. Codeine can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.

Since acetaminophen and codeine is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An opioid overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Avoid driving or operating machinery until you know how acetaminophen and codeine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects or death could occur.

Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen (sometimes abbreviated as APAP). Taking certain medications together can lead to a fatal overdose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking acetaminophen and codeine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Acetaminophen and codeine may cause serious side effects. Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops;

• a light-headed feeling, like you might pass out;

• confusion, severe drowsiness;

• liver problems--nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects include:

• drowsiness, dizziness, feeling tired;

• nausea, vomiting, stomach pain;

• constipation; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

• other opioids--opioid pain medicine or prescription cough medicine;

• a sedative like Valium--diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;

• drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness;

• drugs that affect serotonin levels in your body--a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may affect acetaminophen and codeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Keep all appointments with your doctor. Your doctor may order certain lab tests to check your body's response to acetaminophen and codeine.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are taking acetaminophen and codeine.

Do not let anyone else take your medication. Acetaminophen and codeine is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Fioricet® with Codeine (containing Acetaminophen, Butalbital, Caffeine, Codeine)
• Phrenilin® with Caffeine, Codeine (containing Acetaminophen, Butalbital, Caffeine, Codeine)