Codeine is a narcotic cough suppressant. It affects the signals in the brain that trigger cough reflex.

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Lortuss EX is a combination medicine used to treat cough, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

Lortuss EX will not treat a cough that is caused by smoking, asthma, or emphysema.

Lortuss EX may also be used for purposes not listed in this medication guide.

Codeine can slow or stop your breathing, and may be habit-forming. MISUSE OF Lortuss EX CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

This medicine is not for use in anyone under 18.

Taking this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

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

Follow all directions on your prescription label. Codeine can slow or stop your breathing. Never use Lortuss EX in larger amounts, or for longer than prescribed. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Codeine may be habit-forming, even at regular doses. Never share Lortuss EX with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away codeine is against the law.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication.

Do not take for longer than 7 days in a row. Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

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.

Keep track of your medicine. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

You should not use this medicine if you are allergic to codeine, guaifenesin, or pseudoephedrine.

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.

In some people, codeine breaks down rapidly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death, especially in a child.

Do not give this medicine to anyone younger than 18 years old.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• asthma, COPD, or other breathing disorders;

• a cough with mucus;

• heart disease, high blood pressure;

• a stroke, or a blood vessel disorder;

• drug or alcohol addiction;

• glaucoma;

• liver or kidney disease;

• a blockage in your stomach or intestines;

• a head injury, brain tumor, or seizure;

• diabetes;

• Addison's disease (an adrenal gland disorder);

• a thyroid disorder; or

• enlarged prostate and urination problems.

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. Tell your doctor if you are pregnant or plan to become pregnant.

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

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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, confusion, hallucinations, cold and clammy skin, pinpoint pupils, and fainting.

Lortuss EX may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Do not drink alcohol while you are taking medicine that contains codeine. Dangerous side effects or death could occur.

Ask a doctor or pharmacist before using any other cold, allergy, or cough medicine. Many combination medicines contain decongestants or cough suppressants. Taking certain products together can cause you to get too much of a certain drug.

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

Like other narcotic medications, codeine can slow your breathing. Death may occur if breathing becomes too weak.

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;

• severe drowsiness, hallucinations;

• fast, slow, or uneven heart rate;

• a seizure;

• nervousness, tremors; or

• little or no urination.

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

Common side effects of Lortuss EX may include:

• dizziness, drowsiness, weakness;

• headache;

• nausea, constipation;

• sleep problems (insomnia); or

• feeling nervous, anxious, or restless.

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.

Ask a doctor or pharmacist before using this medicine if you are also using any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are listed in this medication guide.

Taking Lortuss EX with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.