Poly-Tussin AC

Brompheniramine is an antihistamine that lowers the effects of histamine, a natural chemical in the body. Histamine can cause symptoms like sneezing, itching, watery eyes, and a runny nose.

Codeine is a narcotic cough suppressant. It influences the brain signals that cause the cough reflex.

Phenylephrine is a decongestant that narrows blood vessels in the nasal passages. Widened blood vessels can lead to nasal congestion (stuffy nose).

Poly-Tussin AC is a combination medicine used to relieve a runny or stuffy nose, sneezing, itching, watery eyes, cough, and sinus congestion due to allergies, the common cold, or the flu.

Poly-Tussin AC will not treat a cough caused by smoking, asthma, or emphysema.

Poly-Tussin AC may also be used for other purposes not mentioned in this medication guide.

Follow all instructions on your prescription label. Codeine can slow or stop your breathing. Never use Poly-Tussin AC 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 Poly-Tussin AC with anyone else, 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 anyone using the medicine without a prescription. Selling or giving away codeine is against the law.

You should not use antihistamine medication to make a child sleepy.

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.

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. Do not freeze.

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 may lead to dependence. MISUSE OF Poly-Tussin AC CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or anyone using the medicine without a prescription.

This medicine is not for use by anyone under 18.

You should not use this medicine if you are allergic to codeine, phenylephrine, or brompheniramine.

Do not use this medicine if you have taken an MAO inhibitor in the last 14 days. A dangerous drug interaction 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 than normal levels in the body. This can cause dangerously slow breathing and may lead to 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:

• asthma, COPD, bronchitis, or other breathing disorders;
• a cough with mucus;
• heart disease, high blood pressure;
• glaucoma;
• diabetes;
• 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. Brompheniramine may decrease breast milk production.

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;
• a slow heart rate or weak pulse;
• nervousness, trouble sleeping;
• severe constipation; 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 Poly-Tussin AC may include:

• drowsiness; or
• feeling restless or excited (especially in children).

Side effects such as dry mouth, constipation, and confusion may be more likely in older adults.

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 regular 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 dose, skip the missed dose. Do not take extra medicine to make up for 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 another 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.

Poly-Tussin AC may affect your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can result in 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, cough, or sleep medicine. Many combination medicines contain antihistamines, decongestants, or cough suppressants. Taking certain products together can lead to getting too much of a certain 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 taken together. Not all possible interactions are listed in this medication guide.

Taking Poly-Tussin AC 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.