Uses of Hydrocodone, Pseudoephedrine, and Guaifenesin:

• It is used to treat nose stuffiness.
• It is used to thin mucus so it can be taken from the body by coughing.
• It is used to relieve coughing.

Children:

• The use of hydrocodone in children younger than 6 years has led to deadly breathing problems. Talk with the doctor.
• This medicine is not for use in children younger than 18 years of age. The benefits of taking hydrocodone, pseudoephedrine, and guaifenesin for a cough due to allergies, a cold, or other infection do not outweigh the risks in children. If your child has been given hydrocodone, pseudoephedrine, and guaifenesin or if you have any questions, talk with your child's doctor.

What do I need to tell my doctor BEFORE I take Hydrocodone, Pseudoephedrine, and Guaifenesin?

• If you are allergic to hydrocodone, pseudoephedrine, and guaifenesin; any part of hydrocodone, pseudoephedrine, and guaifenesin; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Glaucoma, heart disease, high blood pressure, or trouble passing urine.
• If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
• If you have a cough with a lot of mucus.
• If you have a long-term cough caused by smoking or being around smoke, or lung problems like asthma or emphysema.
• If you have had a recent head injury, brain injury or tumor, or raised pressure in the brain.
• If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.
• If you are taking any of these drugs: Linezolid or methylene blue.
• If you are breast-feeding. Do not breast-feed while you take hydrocodone, pseudoephedrine, and guaifenesin.

This is not a list of all drugs or health problems that interact with hydrocodone, pseudoephedrine, and guaifenesin.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take hydrocodone, pseudoephedrine, and guaifenesin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Hydrocodone, Pseudoephedrine, and Guaifenesin?

• Tell all of your health care providers that you take hydrocodone, pseudoephedrine, and guaifenesin. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take hydrocodone, pseudoephedrine, and guaifenesin for longer than you were told by your doctor.
• Avoid driving and doing other tasks or actions that call for alertness while you take hydrocodone, pseudoephedrine, and guaifenesin.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• If you have been taking hydrocodone, pseudoephedrine, and guaifenesin on a regular basis and you stop it all of a sudden, you may have signs of withdrawal. Do not stop taking hydrocodone, pseudoephedrine, and guaifenesin all of a sudden without calling your doctor. Tell your doctor if you have any bad effects.
• Do not take hydrocodone, pseudoephedrine, and guaifenesin with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take hydrocodone, pseudoephedrine, and guaifenesin.
• This medicine may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking hydrocodone, pseudoephedrine, and guaifenesin.
• Long-term use of an opioid drug may lead to lower sex hormone levels. Call your doctor if you have a lowered interest in sex, fertility problems, no menstrual period (women), or change in sex ability (men).
• If you are 65 or older, use hydrocodone, pseudoephedrine, and guaifenesin with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking hydrocodone, pseudoephedrine, and guaifenesin, call your doctor right away.

How is this medicine (Hydrocodone, Pseudoephedrine, and Guaifenesin) best taken?

• Use hydrocodone, pseudoephedrine, and guaifenesin as ordered by your doctor. Read all information given to you. Follow all instructions closely.
• Take with or without food. Take with food if it causes an upset stomach.
• Take by mouth only.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
• Measure liquid doses carefully. Use the measuring device that comes with hydrocodone, pseudoephedrine, and guaifenesin. If there is none, ask the pharmacist for a device to measure hydrocodone, pseudoephedrine, and guaifenesin.
• Do not use a household teaspoon or tablespoon to measure hydrocodone, pseudoephedrine, and guaifenesin. Doing so could lead to the dose being too high.
• Rinse the measuring device with water after each use.

What do I do if I miss a dose?

• If you take hydrocodone, pseudoephedrine, and guaifenesin on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times hydrocodone, pseudoephedrine, and guaifenesin is taken on an as needed basis. Do not take more often than told by the doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Chest pain or pressure or a fast heartbeat.
• Trouble breathing, slow breathing, or shallow breathing.
• Feeling confused.
• A heartbeat that does not feel normal.
• Hallucinations (seeing or hearing things that are not there).
• Mood changes.
• Seizures.
• Very bad belly pain.
• Trouble passing urine.
• Shakiness.
• Change in eyesight.
• Very upset stomach or throwing up.
• Very bad constipation.
• Feeling very tired or weak.
• Feeling very sleepy.
• Anxiety.
• Taking an opioid drug like hydrocodone, pseudoephedrine, and guaifenesin may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.
• A severe and sometimes deadly problem called serotonin syndrome may happen if you take hydrocodone, pseudoephedrine, and guaifenesin with certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or severe headache.

What are some other side effects of Hydrocodone, Pseudoephedrine, and Guaifenesin?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.
• Headache.
• Constipation.
• Feeling sleepy.
• Upset stomach or throwing up.
• Sweating a lot.
• Feeling tired or weak.
• Dry mouth.
• Restlessness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Hydrocodone, Pseudoephedrine, and Guaifenesin?

• Store at room temperature.
• Keep lid tightly closed.
• Protect from heat and sunlight.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time hydrocodone, pseudoephedrine, and guaifenesin is refilled. If you have any questions about hydrocodone, pseudoephedrine, and guaifenesin, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.