(a-seet-a-MIN-oh-fen) (KOH-deen)

Acetaminophen and codeine (Tylenol® with Codeine Phosphate) is a combination medicine made up of codeine (an opioid medication) and acetaminophen (a non-opioid medication) and is used to relieve pain. Ask the care team (providers and nurses) about your child’s plan. This plan may include other ways such as deep breaths to relax or distract to help keep your child’s mind off the pain.

What Is General Safety Information When Taking Acetaminophen and Codeine Phosphate?

Things to know before you begin taking this medicine:

This medication can cause very serious breathing problems. The following groups of children are more at risk for serious breathing problems:

• Children under the age of 12 years old.
• Children between 12 and 18 years old who are very overweight or lung or breathing problems including sleep apnea or any lung disease.
• Children between 12 and 18 years old who have had a surgery to remove their tonsils or adenoids.

Talk to your doctor before starting this medication if your child is included in one of the groups listed above.

Take the medicine exactly as ordered. Your child should take this medication no more than five times in one day.

Read the insert that comes with the medicine to learn more about the how it works and any possible side effects.

When taking this medication, do not give any other medicines with acetaminophen (Tylenol). More than the safe dose of acetaminophen could cause serious liver damage.

Tell your provider about other medicine your child is taking. Some medicines may need to be changed.

• Do not take over-the-counter (OTC) medicines without talking to your provider.
• Do not take the medicine unless it was prescribed for you.
• Do not share or give the medicine to anyone else.
• Do not use medicines after the expiration date on the bottle/package.
• Do not take these medicines while pregnant.

Things to know while taking this medicine:

Watch your child for serious side effects especially after the first dose. Acetaminophen with codeine may decrease how often and deeply your child takes a breath.

Your child is at risk to fall while taking this medicine. Support them when they walk and crawl. Help them when going up and down the stairs.

• Do not climb, bike or play sports.
• Do not give this medicine if your child is too sleepy or difficult to arouse (wake up).
• Do not drive or operate any heavy machines, or make important decisions.
• Do not drink alcohol or use marijuana while taking this medicine.
• Do not take other medicines that can cause sleepiness unless you have talked to the doctor and are told to do so.
• For opioids prescribed for long-term use, do not stop those medicines without talking to your provider.

Keep track of (count) how much medicine you have so you know if someone else is taking the medicine.

What Are Side Effects of Acetaminophen and Codeine Phosphate?

Side effects may include:

• Feeling sleepy
• Dizziness
• Itching
• Nausea (upset stomach), vomiting (throwing up)
• Constipation (trouble pooping), trouble peeing
• Hallucinations (not making sense when they talk)
• Slowed breathing – This is the most serious side effect; it usually occurs right after taking the opioid medicine.

When Should You Call Your Child’s Provider?

Call your child's provider if:

• Your child has any unusual, long lasting, or serious side effects.
• The current medicine or amount of medicine does not reduce severe pain.

When to Call 911

Call 911 if person who took the medicine becomes:

• Too sleepy or trouble waking up
• Does not respond to your voice
• Trouble breathing

Call the Drug and Poison Information Center if the person who took the drug is still awake and alert at 513-636-5111 or 1-800-222-1222.

What Is Safe Medicine Storage and Disposal?

Storage

• Lock up opioid medicines in a safe place.
• Keep medicine in original package.
• Keep track of how much medicine you have. Count it.
• Always use a child-resistant cap.
• Relock the cap after each use.
• Keep the medicine away from children and animals.

Disposal

Dispose of unused opioid medicines right away. Do not save the medicine for future use. This avoids possible misuse, abuse and intake by accident.

• Visit Drugs@FDA for exact disposal of the medicine your child is taking.
• Call your local pharmacy to see if they have a drug drop off site.
• If a drug drop off site is not readily available, flush the unused opioid medicine down the toilet.

What Are Additional Risks When Taking Acetaminophen and Codeine Phosphate?

Tolerance/Dependence

Those who take opioids for a long period of time can develop a tolerance to them. This means they may need more opioid for the same pain relief.

Withdrawal:

Those who take opioids for a long period of time and suddenly stop taking these medicines may have withdrawal symptoms. This may happen after becoming tolerant or dependent.

Symptoms of withdrawal:

• Agitation or being anxious
• Sweatiness
• Palpitations (fast heart beat)
• Shortness of breath
• Diarrhea
• Nausea (upset stomach), vomiting (throwing up)
• Goose bumps

Addiction

Long-term use of opioid medicines can be addictive. The goal of the care team is to:

• Take care of the severe pain
• Use the lowest amount of medicine that works well
• Use for the shortest amount of time

It is very rare for a child to become addicted to pain relief medicine.

It is best to talk to your provider if you have concerns about this due to the child or a family member with addiction problems.

Studies in adults (without cancer pain) have shown that opioid use for five days can increase the risk for addiction.

Opioid medicines are listed by the DEA (Drug Enforcement Agency) as controlled substances. These medications are regulated for safety because of their side effects and risk of addiction.