Mar-cof CG

You should not take this medicine if you are allergic to codeine or guaifenesin.

In some people, codeine breaks down rapidly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death, especially in a child.

Ask a doctor before giving this medicine to a child younger than 12 years old.

Medicines that contain codeine should not be used in anyone under 18 who recently had surgery to remove the tonsils or adenoids.

To make sure codeine and guaifenesin is safe for you, tell your doctor if you have ever had:

• a cough with mucus;

• asthma, COPD, or other breathing disorder;

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

• a head injury or brain tumor;

• low blood pressure; or

• drug or alcohol addiction.

If you use codeine 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. Codeine can pass into breast milk and may cause drowsiness, breathing problems, or death in a nursing baby. Do not breast-feed.

Since codeine and guaifenesin is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

• If you have an allergy to guaifenesin, codeine, or any other part of Mar-Cof CG.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• 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 mucous.
• If you have a long-term cough caused by smoking or being around smoke, or lung problems like asthma or emphysema.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.
• If you are taking any of these drugs: Linezolid or methylene blue.
• If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
• If you are breast-feeding. Do not breast-feed while you take Mar-Cof CG.

This is not a list of all drugs or health problems that interact with this medicine.

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 Mar-Cof CG with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. 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 use longer than you have been told by the doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Mar-Cof CG affects you.
• 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.
• This medicine may be habit-forming with long-term use.
• Do not take this medicine 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 Mar-Cof CG.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Different brands of Mar-Cof CG (guaifenesin and codeine) may have different doses for children. Talk with the doctor before giving this medicine to a child.
• The chance of very bad side effects may be higher in children. This may be more likely to happen in children who have breathing problems. Deadly breathing problems have happened with the use of codeine in some children. Talk with the doctor.
• 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 Mar-Cof CG, call your doctor right away.
• Using this medicine for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.

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:

• Hard stools (constipation).
• Dizziness.
• Feeling sleepy.
• Upset stomach or throwing up.
• Sweating a lot.
• Feeling tired or weak.

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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Chest pain or pressure or a fast heartbeat.
• Trouble breathing, slow breathing, or shallow breathing.
• Noisy breathing.
• Feeling very sleepy.
• 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.
• Very bad headache.
• Trouble passing urine.
• Shakiness.
• Change in eyesight.
• Very upset stomach or throwing up.
• Very hard stools (constipation).
• Feeling very tired or weak.

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:

• Hard stools (constipation).
• Dizziness.
• Feeling sleepy.
• Upset stomach or throwing up.
• Sweating a lot.
• Feeling tired or weak.

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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.