Capital/Codeine; Tylenol with Codeine #3; Tylenol with Codeine #4
Acet-Codeine; PHL-Acet-Codeine; PMS-Acetaminophen with Codeine Elixir; Procet-30; ratio-Emtec-30; ratio-Lenoltec No. 4
- This drug is a strong pain drug that can put your child at risk for addiction, abuse, and misuse. Misuse or abuse of this drug can lead to overdose and death. Talk with your child’s doctor.
- This drug may cause very bad and sometimes deadly breathing problems. Call the doctor right away if your child has slow, shallow, or trouble breathing.
- The chance of very bad and sometimes deadly breathing problems may be greater when your child first starts this drug or anytime the dose is raised. Talk with your child’s doctor.
- Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away.
- Some children have had very bad and sometimes deadly breathing problems when using codeine after surgery to remove tonsils or adenoids. Do not give to a child who has had surgery to remove tonsils or adenoids. Talk with your child’s doctor.
- This drug has acetaminophen in it. Very bad and sometimes deadly liver problems like the need for a liver transplant have happened with acetaminophen use. Most of the time, liver problems have happened in people who took more acetaminophen in a day than they were told. Also, people who had liver problems were often using more than 1 drug that had acetaminophen in it. Talk with the doctor.
- This drug has an opioid drug in it. The use of opioid drugs along with a benzodiazepine drug or other drugs that may make you drowsy or slow your actions has led to very bad side effects. Side effects that have happened include slowed or trouble breathing and deaths. Benzodiazepine drugs include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepine drugs are used to treat many health problems like anxiety, trouble sleeping, or seizures. Talk with the doctor.
- Many other drugs interact with this drug. These drugs can raise the chance of side effects as well as very bad and sometimes deadly breathing problems. Talk with the doctor and pharmacist to make sure that it is safe for your child to use this drug with all of his/her other drugs.
- Alcohol may interact with this drug. Be sure your child does not drink alcohol.
- Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.
If your child is pregnant:
- Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.
All liquid products:
- Be sure that you know how to measure your child’s dose. Dosing errors can lead to accidental overdose and death. If you have any questions, talk with your child’s doctor or pharmacist.
- It is used to ease pain.
- If your child has an allergy to this drug or any part of this drug.
- If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If your child has any of these health problems: Very bad lung problems like asthma or trouble breathing, high levels of carbon dioxide in the blood, or stomach or bowel block or narrowing.
- If your child is taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
- Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
- Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
- This drug may be habit-forming with long-term use.
- If your child has been taking this drug for a long time or at high doses, it may not work as well and your child may need higher doses to get the same effect. This is known as tolerance. Call the doctor if this drug stops working well. Do not give more than ordered.
- If your child has been taking this drug on a regular basis and stops taking it all of a sudden, your child may have signs of withdrawal. Do not stop giving this drug all of a sudden without calling the doctor. Tell the doctor if your child has any bad effects.
- Avoid giving your child other sources of acetaminophen. Check labels closely. Too much acetaminophen may cause problems.
- Call the doctor right away if you give your child more acetaminophen in a day than you were told, even if your child feels well.
- This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
- If your child is taking warfarin, talk with the doctor. Your child may need to have blood work checked more closely while taking it with this drug.
- Do not give this drug with other strong pain drugs or pain patches without talking to your child’s doctor first.
- Be careful if your child has G6PD deficiency. Anemia may happen.
- Long-term use of strong pain drugs like this drug may lead to lower sex hormone levels. This may lead to signs like change in sex ability in males, no menstrual period in females, lowered interest in sex, or fertility problems. If any of these apply to your child, call your child’s doctor.
- The chance of very bad side effects may be higher in children. This may be more likely to happen in children who have breathing problems. Deadly breathing problems have happened with the use of codeine in some children. Talk with the doctor.
- Use with care in children. Talk with the doctor.
If your child is pregnant or breast-feeding a baby:
- This drug may cause harm to the unborn baby if your child takes it during pregnancy. If your child is pregnant or gets pregnant while taking this drug, call the doctor right away.
- Tell your child’s doctor if your child is breast-feeding a baby. This drug passes into breast milk and may harm your child’s baby.
- If your child is allergic to sulfites, talk with your child’s doctor. Some products have sulfites in them.
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Very bad dizziness or passing out.
- Feeling confused.
- Feeling very tired or weak.
- Very hard stools (constipation).
- Not able to pass urine or change in how much urine is passed.
- Fever or chills.
- Sore throat.
- Mood changes.
- Very bad headache.
- Noisy breathing.
- Feeling very sleepy.
- Any unexplained bruising or bleeding.
- Change in eyesight.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
- A very bad and sometimes deadly health problem called serotonin syndrome may happen if your child takes this drug with drugs for depression, migraines, or certain other drugs. Call the doctor right away if your child has agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
- Taking strong pain drugs like this drug may lead to a rare but very bad adrenal gland problem. Call your child’s doctor right away if your child has very bad dizziness or passing out, very bad upset stomach or throwing up, or if your child feels less hungry, very tired, or very weak.
- Hard stools (constipation).
- Feeling sleepy.
- Belly pain.
- Upset stomach or throwing up.
- Give this drug with or without food. Give with food if it causes an upset stomach.
- Have your child drink lots of noncaffeine liquids every day unless told to drink less liquid by your child’s doctor.
All liquid products:
- Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
- Shake well before use.
- If your child takes this drug on a regular basis, give a missed dose as soon as you think about it.
- If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
- Do not give 2 doses at the same time or extra doses.
- Many times this drug is given on an as needed basis. Do not give to your child more often than told by the doctor.
- Store at room temperature.
- Protect from light.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
- If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
- Do not share your child’s drug with others and do not give anyone else’s drug to your child.
- Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
- Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.