Tuzistra XR

Codeine and Chlorpheniramine Extended-Release Suspension

(KOE deen & klor fen IR a meen)

Tuzistra XR

This drug has an opioid drug in it. Opioid drugs can put you at risk for addiction, abuse, and misuse. Misuse or abuse of this drug can lead to overdose and death. If you have questions, talk with your doctor. This drug may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing. The chance of very bad and sometimes deadly breathing problems may be greater when you first start this drug or anytime your dose is raised. 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. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. This drug has an opioid drug in it. Severe side effects have happened when opioid drugs were used with benzodiazepines or other drugs that may make you drowsy or slow your actions. This includes slow or troubled breathing and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepines may be used to treat many health problems like anxiety, trouble sleeping, or seizures. If you have questions, talk with your doctor. Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs. Do not take with alcohol or products that have alcohol. Unsafe and sometimes deadly effects may happen. 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. Do not take if you are 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. Be sure that you know your dose and how to take this drug. Dosing errors can lead to accidental overdose and death. If you have any questions, talk with your doctor or pharmacist.

It is used to ease allergy signs. It is used to relieve coughing. Children: This drug is not for use in children younger than 18 years of age. The benefits of taking this drug for a cough due to allergies, a cold, or other infection do not outweigh the risks in children. If your child has been given this drug or if you have any questions, talk with your child's doctor.

If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. If you have had a recent head injury, brain injury or tumor, or raised pressure in the brain. If you have a cough with a lot of mucus. If you have a long-term cough caused by smoking or being around smoke, or lung problems like asthma or emphysema. If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing. If you have an infection or an illness with a fever. If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen. If you are taking any of these drugs: Linezolid or methylene blue. If you have been told by your doctor that you are a rapid metabolizer of some drugs. If you are breast-feeding. Do not breast-feed while you take this drug. This is not a list of all drugs or health problems that interact with this drug. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

For all patients taking this drug: Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects. Do not take this drug for longer than you were told by your doctor. Avoid driving and doing other tasks or actions that call for alertness while you take this drug. To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs. If you have been taking this drug on a regular basis and you stop it all of a sudden, you may have signs of withdrawal. Do not stop taking this drug all of a sudden without calling your doctor. Tell your doctor if you have any bad effects. Do not take this drug with other strong pain drugs or if you are using a pain patch without talking to your doctor first. This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug. This drug may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking this drug. Long-term use of an opioid drug may lead to lower sex hormone levels. Call your doctor if you have a lowered interest in sex, fertility problems, no menstrual period (women), or change in sex ability (men). If you are 65 or older, use this drug with care. You could have more side effects. This drug may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this drug, call your doctor right away. Children: 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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: 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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight. Shortness of breath. Noisy breathing. Feeling very tired or weak. Feeling confused. Fast, slow, or abnormal heartbeat. Hallucinations (seeing or hearing things that are not there). Depression or other mood changes. Seizures. Trouble passing urine. Shakiness. Change in eyesight. Severe constipation or stomach pain. These may be signs of a severe bowel problem. Trouble controlling body movements. Feeling agitated. Restlessness. Taking an opioid drug like this drug may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak. A severe and sometimes deadly problem called serotonin syndrome may happen if you take this drug with certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or severe headache.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Feeling dizzy, sleepy, tired, or weak. Feeling nervous and excitable. Trouble sleeping. Constipation. Upset stomach or throwing up. Sweating a lot. Headache. Dry mouth. Stomach pain. Bloating. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. Take with or without food. Take with food if it causes an upset stomach. Take by mouth only. 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. Do not use a household teaspoon or tablespoon to measure this drug. Doing so could lead to the dose being too high. Do not mix with other liquids. Shake well before use.

If you take this drug on a regular basis, take a missed dose as soon as you think about it. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not take 2 doses at the same time or extra doses. Many times this drug is taken on an as needed basis. Do not take more often than told by the doctor.

Store at room temperature protected from light. Store in a dry place. Do not store in a bathroom. Store this drug in a safe place where children cannot see or reach it, and where other people cannot get to it. A locked box or area may help keep this drug safe. Keep all drugs away from pets. Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. This drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled. If you have any questions about this drug, please talk with the doctor, 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.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.