chlorpheniramine, hydrocodone, and pseudoephedrine

Pronunciation: KLOR fe NEER a meen, HYE droe KOE done, SOO doe ee FED rin

Brand: Hydron PCS, Zutripro

What is the most important information I should know about this medicine?

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

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

What is chlorpheniramine, hydrocodone, and pseudoephedrine?

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.

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

Chlorpheniramine, hydrocodone, and pseudoephedrine is a combination medicine used to treat runny or stuffy nose, sneezing, cough, and sinus congestion caused by allergies or the common cold.

Chlorpheniramine, hydrocodone, and pseudoephedrine may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking this medicine?

You should not use this medicine if you are allergic to chlorpheniramine, hydrocodone, or pseudoephedrine, or if you have:

  • severe asthma or breathing problems;
  • a stomach or bowel obstruction (including paralytic ileus);
  • severe or uncontrolled high blood pressure;
  • severe coronary artery disease (clogged arteries);
  • narrow-angle glaucoma; or
  • if you are unable to urinate.

This medicine is not approved for use by anyone younger than 18 years old.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Tell your doctor if you have ever had:

  • lung disease or breathing problems;
  • a head injury, brain tumor, or seizure;
  • constipation, a bowel obstruction, or stomach problems;
  • problems with your bile duct or pancreas;
  • an enlarged prostate;
  • urination problems;
  • liver or kidney disease;
  • low blood pressure;
  • heart disease, a blood vessel disorder;
  • a drug addiction;
  • an adrenal gland disorder; or
  • if you have a fever and cough with mucus.

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.

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

How should I take this medicine?

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 this medicine is against the law.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon). Rinse after each use.

Call your doctor if your symptoms do not improve after 5 days, or if you also have a fever.

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.

Do not keep leftover medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Read and carefully follow the instructions provided with this medicine about how to safely dispose of any unused portion.

What happens if I miss a dose?

Since this medicine 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.

What happens if I overdose?

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.

What should I avoid while taking this medicine?

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

What are the possible side effects of this medicine?

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, 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 taking this medicine and call your doctor at once if you have:

  • noisy breathing, sighing, shallow breathing;
  • a slow heart rate or weak pulse;
  • fast heartbeats, dizziness, weakness, tremors, trouble sleeping;
  • a seizure;
  • a light-headed feeling, like you might pass out;
  • severe constipation;
  • little or no urination; or
  • adrenal gland problems -- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

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 overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects may include:

  • drowsiness, dizziness;
  • lack of energy, coordination problems;
  • headache, confusion;
  • dry mouth, nausea, vomiting, constipation;
  • tremors, fast or irregular heart rate; or
  • feeling anxious, restless, nervous, or irritable.

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.

What other drugs will affect this medicine?

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.

Tell your doctor about all your current medicines. Many drugs can affect chlorpheniramine, hydrocodone, and pseudoephedrine, especially:

  • other cough, cold, or allergy medicines;
  • asthma medication;
  • an antibiotic, antiviral, or antifungal medicine;
  • pain medicine or a muscle relaxer;
  • medicine to treat depression, anxiety, mood disorders, or mental illness;
  • heart or blood pressure medication;
  • a diuretic or "water pill";
  • bladder or urinary medicines;
  • seizure medication; or
  • medicine to treat stomach problems.

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

Where can I get more information?

Your pharmacist can provide more information about chlorpheniramine, hydrocodone, and pseudoephedrine.

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