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

Hycodan contains an opioid cough medicine and may be habit-forming.

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

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.

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 have a fever, rash, or headaches.

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.

You should not use Hycodan if you are allergic to homatropine or hydrocodone, 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.

Do not give this medicine to anyone younger than 6 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, pancreas, or adrenal gland;

• an enlarged prostate;

• urination problems;

• liver or kidney disease;

• low blood pressure;

• heart disease, a blood vessel disorder;

• a drug addiction; or

• if you have a fever and cough with mucus.

If you use opioid medicine 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 opioids may need medical treatment for several weeks.

Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Since Hycodan 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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An opioid overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

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

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

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

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or 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 Hycodan and call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing;

• extreme drowsiness, confusion, feeling weak or limp;

• a seizure;

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

• severe constipation, stomach pain;

• little or no urination;

• adrenal gland problems--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or

• high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects of Hycodan 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.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

• other opioids--opioid pain medicine or prescription cough medicine;

• a sedative like Valium--diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;

• drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness;

• drugs that affect serotonin levels in your body--a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may affect Hycodan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.