Tussionex PennKinetic is an extended release oral suspension containing a combination of of chlorpheniramine and hydrocodone.

Chlorpheniramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

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

Tussionex PennKinetic is used to treat runny nose, sneezing, itching, watery eyes, and cough caused by allergies, the common cold, or the flu.

MISUSE OF Tussionex PennKinetic CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction.

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

To be sure you get the correct dose, measure this medicine carefully with a marked measuring spoon or syringe, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not give Tussionex PennKinetic to a child younger than 18 years old.

Before you take Tussionex PennKinetic, tell your doctor if you have asthma or another breathing disorder, a history of head injury or brain tumor, stomach or intestinal problems, liver or kidney disease, glaucoma, urination problems or an enlarged prostate, Addison's disease, or underactive thyroid.

Take Tussionex PennKinetic exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides. Never use Tussionex PennKinetic in larger amounts, or for longer than prescribed.

Never share Tussionex PennKinetic 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 Tussionex PennKinetic is against the law.

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

Do not mix the oral suspension with any other liquids or medicines.

Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.

Call your doctor if your symptoms do not improve after 5 days of treatment, or if you have a fever with a headache or skin rash.

If you need surgery, tell the surgeon ahead of time that you are using Tussionex PennKinetic.

Store at room temperature away from moisture and heat. Do not freeze.

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

Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using the medicine.

Usual Adult Dose for Cough and Cold Symptoms:

Extended-release Oral Suspension: 5 mL orally every 12 hours
Maximum dose: 2 doses (10 mL) in 24 hours

Use: For the symptomatic relief of cough and upper respiratory symptoms associated with allergy or a cold.

Comments:
-Oral suspension must be measured with an accurate milliliter measuring device; do not use a household teaspoon.

You should not use Tussionex PennKinetic if you are allergic to chlorpheniramine or hydrocodone.

Do not use Tussionex PennKinetic 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.

Do not give this medicine to a child younger than 6 years old. Tussionex PennKinetic is not approved for use by anyone younger than 18 years old.

Tell your doctor if you have ever had:

• asthma or other breathing problems;

• seizures, or a head injury or brain tumor;

• a blockage in your digestive tract (stomach or intestines);

• enlarged prostate, urination problems;

• low blood pressure;

• liver or kidney disease;

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

• problems with your thyroid, gallbladder, or pancreas; or

• alcoholism or drug addiction.

If you use hydrocodone 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.

You should not breast-feed while using Tussionex PennKinetic.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A hydrocodone 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 operating machinery until you know how Tussionex PennKinetic will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Ask a doctor or pharmacist before using other cough or cold medicines that may contain similar ingredients.

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

Like other narcotic medications, hydrocodone 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 using this medicine and call your doctor at once if you have:

• severe drowsiness;

• noisy breathing, sighing, shallow breathing;

• severe constipation;

• a light-headed feeling, like you might pass out;

• a slow heart rate or weak pulse;

• confusion; or

• adrenal gland problems - nausea, vomiting, loss of appetite, dizziness, feeling weak or tired.

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

Common Tussionex PennKinetic side effects may include:

• trouble breathing;

• drowsiness;

• confusion;

• nausea, vomiting; or

• little or no urination.

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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Using Tussionex PennKinetic with other drugs that slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• an antibiotic or antifungal medicine;

• antiviral medicine to treat hepatitis or HIV;

• asthma medication;

• bladder or urinary medicines;

• blood pressure medication;

• a diuretic or "water pill";

• medicine to treat a stomach ulcer, motion sickness, or irritable bowel syndrome;

• medicine to treat Parkinson's disease; or

• seizure medicine.

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