Lortuss EX

Codeine is a narcotic cough suppressant. It changes the signals in the brain that cause you to cough.

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

Pseudoephedrine is a decongestant that narrows blood vessels in the nasal passages. Enlarged blood vessels can lead to 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 caused by smoking, asthma, or emphysema.

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

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 go away.

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 keep your throat moist 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.

Codeine can slow or stop your breathing, and it may lead to addiction. MISUSE OF Lortuss EX CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or anyone using the medicine without a prescription.

This medicine is not for anyone under 18.

Using this medicine during pregnancy may cause serious withdrawal symptoms in the newborn.

Fatal side effects can happen if you take this medicine with alcohol or other drugs that make you sleepy or slow your breathing.

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

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

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

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

To ensure 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 lead to life-threatening withdrawal symptoms in the baby after birth. 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.

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.

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

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. A codeine overdose can be deadly, especially in a child or anyone 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 affect your thinking or reactions. Avoid driving or using machinery until you know how this medicine affects you. Dizziness or severe drowsiness can lead to falls or other accidents.

Do not drink alcohol while taking medicine that contains codeine. Serious side effects or death could happen.

Ask a doctor or pharmacist before using any other cold, allergy, or cough medicine. Many combination medicines include decongestants or cough suppressants. Taking certain products together can lead to getting too much of a specific drug.

Ask a doctor or pharmacist before using this medicine if you are also taking 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.