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.

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

Do not give this medicine to anyone younger than 12 years old, or anyone under 18 who recently had surgery to remove the tonsils or adenoids.

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. Cold or cough medicine is only for short-term use 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 chlorpheniramine and codeine is against the law.

Shake the oral suspension (liquid) before you measure a dose. Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

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

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

Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag throw the bag in the trash.

Usual Adult Dose for Allergic Rhinitis:

Immediate-release (suspension, liquid, tablets):
1 dose orally every 4 to 6 hours as needed
-Chlorpheniramine: Single dose: up to 4 mg; Maximum dose: 24 mg/24 hours
-Codeine: Single dose: up to 20 mg; Maximum dose: 120 mg/24 hours
Maximum doses should not exceed maximum dose of either of the single ingredient doses

Extended-release suspension: chlorpheniramine polistirex 2.8 mg/codeine polistirex 14.7 mg per 5 mL (equivalent to chlorpheniramine maleate 4 mg/codeine phosphate 20 mg per 5 mL)
10 mL orally every 12 hours
Maximum dose: 20 mL/24 hours

Comments:
-Liquid preparations should be measured with an accurate milliliter measuring device.
-Shake oral suspensions well before measuring dose.

Uses: For the temporary relief of cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants; temporarily decreases runny nose and reduces sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.

Usual Adult Dose for Cough and Nasal Congestion:

Immediate-release (suspension, liquid, tablets):
1 dose orally every 4 to 6 hours as needed
-Chlorpheniramine: Single dose: up to 4 mg; Maximum dose: 24 mg/24 hours
-Codeine: Single dose: up to 20 mg; Maximum dose: 120 mg/24 hours
Maximum doses should not exceed maximum dose of either of the single ingredient doses

Extended-release suspension: chlorpheniramine polistirex 2.8 mg/codeine polistirex 14.7 mg per 5 mL (equivalent to chlorpheniramine maleate 4 mg/codeine phosphate 20 mg per 5 mL)
10 mL orally every 12 hours
Maximum dose: 20 mL/24 hours

Comments:
-Liquid preparations should be measured with an accurate milliliter measuring device.
-Shake oral suspensions well before measuring dose.

Uses: For the temporary relief of cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants; temporarily decreases runny nose and reduces sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.

You should not use chlorpheniramine and codeine 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.

Since chlorpheniramine and codeine 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.

Do not take extended-release chlorpheniramine and codeine more than 2 times in 24 hours.

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 hazardous activity until you know how chlorpheniramine and codeine 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.

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.

chlorpheniramine and codeine may cause serious side effects. Stop using chlorpheniramine and codeine 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 of chlorpheniramine and codeine 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.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

• other narcotic medications--opioid pain medicine or prescription cough medicine;

• a sedative like Valium--diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;

• drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or

• drugs that affect serotonin levels in your body--a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

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