Uses of Promethazine, Phenylephrine, and Codeine:

• It is used to relieve coughing.
• It is used to ease allergy signs.
• It is used to treat nose stuffiness.
• It is used to ease cold signs.

What do I need to tell my doctor BEFORE I take Promethazine, Phenylephrine, and Codeine?

• If you have an allergy to codeine, phenylephrine, promethazine, or any other part of promethazine, phenylephrine, and codeine.
• If you are allergic to promethazine, phenylephrine, and codeine; any part of promethazine, phenylephrine, and codeine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• 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 high blood pressure.
• If you have any blood flow problems, talk with your doctor.
• 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 are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
• 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 promethazine, phenylephrine, and codeine.

This is not a list of all drugs or health problems that interact with promethazine, phenylephrine, and codeine.

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 promethazine, phenylephrine, and codeine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Promethazine, Phenylephrine, and Codeine?

• Tell all of your health care providers that you take promethazine, phenylephrine, and codeine. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may be habit-forming with long-term use.
• This medicine may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.
• This medicine is not for coughs due to smoking or lung disease.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take promethazine, phenylephrine, and codeine.
• This medicine may cause the results of some pregnancy tests to be wrong. Talk with the doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how promethazine, phenylephrine, and codeine affects you.
• 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.
• This medicine 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 promethazine, phenylephrine, and codeine.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• If you are 65 or older, use promethazine, phenylephrine, and codeine with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using promethazine, phenylephrine, and codeine while you are pregnant.
• Using promethazine, phenylephrine, and codeine for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.

How is this medicine (Promethazine, Phenylephrine, and Codeine) best taken?

Use promethazine, phenylephrine, and codeine 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.
• Measure liquid doses carefully. Use the measuring device that comes with promethazine, phenylephrine, and codeine. If there is none, ask the pharmacist for a device to measure promethazine, phenylephrine, and codeine.

What do I do if I miss a dose?

• If you take promethazine, phenylephrine, and codeine 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 promethazine, phenylephrine, and codeine is taken on an as needed basis. Do not take more often than told by the doctor.

What are some side effects that I need to call my doctor about right away?

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.
• Noisy breathing.
• Feeling very sleepy.
• Very bad constipation.
• Not able to pass urine or change in how much urine is passed.
• Feeling very tired or weak.
• Hallucinations (seeing or hearing things that are not there).
• Mood changes.
• Ringing in ears.
• Seizures.
• Any unexplained bruising or bleeding.
• Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
• Yellow skin or eyes.
• Chest pain or pressure or a fast heartbeat.
• Restlessness.
• Shakiness.
• Very bad belly pain.
• A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.
• Low white blood cell counts have rarely happened with promethazine, phenylephrine, and codeine. This may lead to a higher chance of getting an infection. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.

What are some other side effects of Promethazine, Phenylephrine, and Codeine?

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 sleepy.
• Dizziness.
• Feeling nervous and excitable.
• Constipation.
• Dry mouth.
• Dry nose.
• Headache.
• Not able to sleep.
• Upset stomach or throwing up.

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.

If OVERDOSE is suspected:

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.

How do I store and/or throw out Promethazine, Phenylephrine, and Codeine?

• 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.
• 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.

Consumer Information Use and Disclaimer

• 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 medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time promethazine, phenylephrine, and codeine is refilled. If you have any questions about promethazine, phenylephrine, and codeine, 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.