Codeine, phenylephrine, and promethazine is a combination medicine used to treat runny or stuffy nose, sneezing, cough, and sinus congestion caused by allergies or the common cold.

Codeine, phenylephrine, and promethazine contains a narcotic cough medicine and may be habit-forming.

Codeine, phenylephrine, and promethazine may also be used for purposes not listed in this medication guide.

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

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

Follow the directions on your prescription label and read all medication guides. Never use this medicine in larger amounts, or for longer than prescribed. Take this medicine only until your symptoms clear up.

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

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon). Rinse after each use.

Call your doctor if your symptoms do not improve after 5 days, or if you have a fever, rash, or headaches.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cough or cold medicine within the past few days.

Store at room temperature away from moisture and heat. Do not freeze. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Read and carefully follow the instructions provided with this medicine about how to safely dispose of any unused portion.

Usual Adult Dose for Cough and Nasal Congestion:

Average effective dose: 5 mL orally every 4 to 6 hours as needed
Maximum dose: 30 mL (promethazine 37.5 mg; phenylephrine: 30 mg; codeine: 60 mg) in 24 hours

Comments:
-Each 5 mL contains Promethazine 6.25 mg/Phenylephrine 5 mg/Codeine 10 mg.
-Liquid preparations should be measured with an accurate milliliter measuring device.

Uses: Temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

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

• severe asthma or breathing problems;

• a stomach or bowel obstruction (including paralytic ileus);

• severe or uncontrolled high blood pressure;

• severe coronary artery disease (clogged arteries);

• narrow-angle glaucoma; or

• if you are unable to urinate.

Do not give this medicine to anyone younger than 6 years old.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Tell your doctor if you have ever had:

• lung disease or breathing problems;

• a head injury, brain tumor, or seizure;

• constipation, a bowel obstruction, or stomach problems;

• problems with your bile duct, pancreas, or adrenal gland;

• an enlarged prostate;

• urination problems;

• liver or kidney disease;

• low blood pressure;

• heart disease, a blood vessel disorder;

• a drug addiction; or

• if you have a fever and cough with mucus.

If you use codeine 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 habit-forming medicine may need medical treatment for several weeks.

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

Since codeine, phenylephrine, and promethazine is used when needed, you may not be on a dosing schedule. Skip any missed dose if it's 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. A codeine overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

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

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

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

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

Stop taking this medicine and call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing;

• extreme drowsiness, confusion, feeling weak or limp;

• a seizure;

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

• severe constipation, stomach pain;

• little or no urination; or

• adrenal gland problems--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects of codeine, phenylephrine, and promethazine may include:

• drowsiness, dizziness;

• lack of energy, coordination problems;

• headache, confusion;

• dry mouth, nausea, vomiting, constipation;

• tremors, fast or irregular heart rate; or

• feeling anxious, restless, nervous, or irritable.

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 certain antibiotics, antifungal medications, seizure medication, or medicines to treat HIV or hepatitis C.

Using this medicine with other drugs that slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your current medicines, especially:

• a sedative like Xanax or Valium (diazepam, alprazolam, lorazepam, and others);

• other cough, cold, or allergy medicines;

• asthma medication;

• pain medicine or a muscle relaxer;

• medicine to treat depression, anxiety, mood disorders, or mental illness;

• heart or blood pressure medication;

• a diuretic or "water pill";

• bladder or urinary medicines;

• seizure medication; or

• medicine to treat stomach problems.

This list is not complete and many other drugs may affect codeine, phenylephrine, and promethazine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.