Chlorpheniramine is an antihistamine. Codeine is a narcotic cough suppressant.

Chlorpheniramine and codeine is a combination medicine used to treat cough, runny nose, and sneezing caused by allergies or the common cold.

Chlorpheniramine and codeine may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to chlorpheniramine or codeine. You may not be able to use this medicine if you have:

• severe asthma or breathing problems; or
• a stomach or bowel obstruction (including paralytic ileus).

Do not use this medicine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Codeine is not approved for use by anyone younger than 12 years old.

Do not give this medicine to anyone younger than 18 years old who recently had surgery to remove the tonsils or adenoids.

Ask a doctor or pharmacist if this medicine is safe to use if you have ever had:

• breathing problems, sleep apnea;
• cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;
• a blockage in your stomach or intestines;
• glaucoma;
• enlarged prostate, urination problems;
• problems with your thyroid, pancreas, or adrenal glands;
• a seizure, head injury, or brain tumor;
• liver or kidney disease;
• low blood pressure; or
• alcoholism or drug addiction.

If you use this medicine while you are pregnant, your baby could become dependent on codeine. 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 breastfeed. Codeine can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.

Use Tuzistra XR (Chlorpheniramine Codeine) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

Opioid medicine 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 using this medicine and call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• confusion, severe drowsiness;
• a light-headed feeling, like you might pass out;
• severe constipation; or
• adrenal gland problems--nausea, vomiting, loss of appetite, feeling very dizzy, weak, or tired.

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 debilitated.

Common side effects may include:

• dizziness, drowsiness, feeling light-headed;
• feeling short of breath;
• confusion, mood changes, lack of energy,
• feeling nervous, irritable, agitated, or restless;
• sleep problems;
• headache, vision problems;
• tremors, coordination problems;
• dry mouth;
• sweating; or
• nausea, vomiting, constipation, stomach pain, bloating.

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.

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

Avoid driving or hazardous activity until you know how this medicine will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or drowsiness can cause falls, accidents, or severe injuries.