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Overview: Codeine/chlorpheniramine is a combination medicine used to reduce coughing and other symptoms from the common cold or allergies. It works by affecting the part of the brain that controls the cough reflex and blocks the effect of a substance in your body called histamine. Common side effects may include constipation and drowsiness. Before using codeine/chlorpheniramine, make sure to tell your healthcare provider about any health conditions or medicines you are taking.

Uses

What is Tuxarin ER used for?

Tuxarin ER (codeine/chlorpheniramine) is commonly used to reduce coughing and other symptoms from allergies or the common cold.

Tuxarin ER may also be used for other conditions as determined by your healthcare provider.

How does Tuxarin ER work (mechanism of action)?

Chlorpheniramine works by blocking certain histamine receptors in the body, which helps to reduce runny nose, congestion, and other symptoms. Codeine reduces the urge to cough by affecting the part of the brain that controls the cough reflex.

How is Tuxarin ER supplied (dosage forms)?

Brands and other names

  • Tuxarin ER

Dosage forms and strengths

  • 54.3 mg/8 mg extended-release oral tablets

How should I store Tuxarin ER?

Tuxarin ER should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. 

Side Effects

What are the most common side effects of Tuxarin ER?

The most common side effects of Tuxarin ER are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Sleepiness or lack of energy
  • Confusion or inability to think clearly
  • Coordination problems or not able to be as physically active as usual
  • Lightheadedness or dizziness
  • Headache
  • Dry mouth
  • Nausea, vomiting, or constipation 
  • Shortness of breath
  • Sweating

There may be other side effects of Tuxarin ER that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Tuxarin ER?

While less common, the most serious side effects of Tuxarin ER are described below, along with what to do if they happen.

Severe Allergic Reactions. Tuxarin ER may cause allergic reactions, which can be serious. Stop taking Tuxarin ER and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Risk of Misuse and Addiction. Misusing Tuxarin ER can lead to serious side effects like coma or death. Misuse means taking a medicine in a way other than how it was prescribed. Take Tuxarin ER exactly as prescribed. Tell your healthcare provider if you feel that Tuxarin ER is not working. Call your healthcare provider right away or go to the nearest emergency room if you have any of the following serious symptoms.

  • Sudden confusion or feeling disoriented
  • Feeling paranoid
  • Suicidal thoughts or actions
  • Seizures
  • Trouble breathing 

Breathing Problems. Tuxarin ER may cause slow or shallow breathing, especially if you have breathing problems from another condition or take other medicines that can slow your breathing. Tell your healthcare provider if you develop severe sleepiness or trouble breathing, especially when you start Tuxarin ER. Get emergency help if you have any of the following symptoms.

  • Changes in the color of your skin, including bluish color to your lips and fingernails
  • Confusion
  • Shortness of breath
  • Feeling dizzy, lightheaded, or fainting
  • Changes in your heart rate or rhythm, such as a fast, slow, pounding or skipping heartbeat
  • Slow or shallow breathing
  • Excessive sleepiness or trouble staying awake

Increased Pain Sensitivity (Hyperalgesia). Tuxarin ER can cause an increased sensitivity to pain. It can cause things that normally cause pain to feel more painful than usual. Tuxarin ER can also cause allodynia. This happens when things that normally do not cause pain, such as wearing glasses or brushing your hair, become painful. If your pain increases, do not take extra doses of Tuxarin ER. This could cause you to overdose or develop other serious side effects. Call your healthcare provider right away if your pain increases, you feel more sensitive to pain, or if you develop pain in other areas of the body. 

Reduced Adrenal Function. Long-term use of Tuxarin ER can cause your body’s adrenal glands to stop making as much cortisol (the stress hormone). This is known as adrenal insufficiency. Adrenal insufficiency can get worse if your body is under stress because of fever, surgery, or trauma. Tell your healthcare provider if you have any of the following symptoms of adrenal insufficiency.

  • Nausea and vomiting
  • Weakness, tiredness, or lack of energy
  • Low blood pressure

Low Blood Pressure (Hypotension). Tuxarin ER may cause low blood pressure or sudden drop in blood pressure when standing up from a seated or lying position (orthostatic hypotension). To help prevent this, be careful not to get up too quickly. If you feel faint or dizzy, lie down. Tell your healthcare provider right away if you have any of the following symptoms of low blood pressure.

  • Dizziness, feeling lightheaded, or fainting
  • Confusion
  • Feeling weak or tired

Blockage of the Gut. Some people taking Tuxarin ER may develop severe constipation or a blockage of the gut (bowel obstruction). Stop taking Tuxarin ER and call your healthcare provider right away if you have any of the following symptoms of a blockage in your intestines.

  • Nausea or vomiting
  • Stomach pain or bloating
  • Loss of appetite 
  • Unable to pass gas

Sphincter of Oddi Spasm. The sphincter of Oddi is a muscular valve in your body that controls the flow of bile and digestive juices from the pancreas into the small intestine. When this valve spasms, it may feel like getting a tight muscle cramp, causing pain and blocking the flow of these juices, which can lead to discomfort and digestive problems. This is more likely to happen if you do not have a gallbladder. Stop taking Tuxarin ER and get emergency help if you have new or worse stomach pain or pain in the upper right side of your stomach area that travels to your back or shoulder, with or without nausea and vomiting. 

Warnings & Precautions

Who should not use Tuxarin ER?

Allergies to Ingredients. People who are allergic to any of the following should not take Tuxarin ER.

  • Codeine
  • Chlorpheniramine
  • Tuxarin ER
  • Any other medicine known as an opioid
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Tuxarin ER.

Drug Interactions. Tuxarin ER should not be taken while you are using certain other medicines. Before taking Tuxarin ER, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using or have used recently. See the Interactions section for more details.

Children. Tuxarin ER should not be used in any child younger than 12 years of age or in a child younger than 18 years of age after a surgery to remove their tonsils or adenoids (tonsillectomy and/or adenoidectomy). Slow or shallow breathing that can lead to death may occur. 

Gut Blockage. Tuxarin ER should not be used if you have a blockage of your gut (bowel obstruction) or a narrowing of the stomach or intestines. Tuxarin ER can make these conditions worse. See the Side Effects section for more details.

Slowed Gut Movement. Paralytic ileus is a type of ileus where your intestines are unable to move food through them. Tuxarin ER can make this condition worse.

Lung Problems. Tuxarin ER should not be used if you have severe asthma, trouble breathing, or other lung problems. Tuxarin ER can make these conditions worse.

What should I know about Tuxarin ER before using it?

Do not take Tuxarin ER unless it has been prescribed to you by a healthcare provider. Take it as prescribed.

Do not share Tuxarin ER with other people, even if they have the same condition as you. It may harm them.

Keep Tuxarin ER out of the reach of children. Tuxarin ER is a controlled substance because it can be misused or lead to dependence. Store Tuxarin ER in a safe place to protect it from theft. It is illegal to sell or give away this medicine.

Tuxarin ER can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how Tuxarin ER affects you.

People who are 65 and older can be at greater risk for some side effects from Tuxarin ER. Talk to your healthcare provider about your risks if you are in this age group.

If you have been taking Tuxarin ER on a regular basis, do not stop taking the medicine without talking to your healthcare provider. Stopping too quickly may cause serious side effects. Call your healthcare provider right away if you have any of the following symptoms. 

  • Feeling restless
  • Watery eyes or runny nose
  • Yawning
  • Sweating or chills
  • Muscle, joint, or back pain
  • Dilated pupils 
  • Irritability, anxiety, or trouble sleeping
  • Nausea, vomiting, diarrhea, or loss of appetite
  • Increase in blood pressure, breathing rate, or heart rate

Dispose of expired, unwanted, or unused Tuxarin ER right away by taking your medicine to an authorized DEA-registered collector or drug take back program. If one is not available, you can mix medicine with dirt, coffee grounds, or cat litter, then place the mixture in a sealed plastic bag and throw the bag in the trash. 

Long-term use of Tuxarin ER may affect your ability to become pregnant or get a partner pregnant. Talk with your healthcare provider if you have any concerns.

Tell your healthcare provider if your cough does not get better after five days of taking Tuxarin ER. They will need to check to see if something else is causing the cough. 

What should I tell my healthcare provider before using Tuxarin ER?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Tuxarin ER is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following. 

  • Head injury or brain problems, such as brain tumors or increased pressure around the brain
  • Seizures
  • Liver, kidney, or adrenal gland problems
  • Stomach, bowel, pancreas, or gallbladder problems
  • Breathing problems, such as asthma or chronic obstructive pulmonary disease (COPD)
  • Obstructive sleep apnea
  • Problems peeing 
  • Prostate problems 
  • Low blood pressure
  • Diabetes
  • Substance use disorder or live with someone with this problem
  • Alcohol use disorder 
  • Mental health problems
  • Fever and coughing up mucus
  • Upcoming surgery 

Pregnancy. Tuxarin ER may cause harm to an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should take Tuxarin ER while you are pregnant or trying to get pregnant. If you take Tuxarin ER on a regular basis during pregnancy, your baby may have withdrawal symptoms that can be life-threatening. Tell your healthcare provider if you took Tuxarin ER during your pregnancy, especially near the end of your pregnancy.

Breastfeeding. Tuxarin ER passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should stop breastfeeding or stop Tuxarin ER.

How can I get more information about Tuxarin ER?

For more information about Tuxarin ER, you can visit the manufacturer’s website at www.mainpointepharmaceuticals.com or call them at 502-709-7544.

Interactions

Does Tuxarin ER interact with foods or drinks?

There are no known interactions between Tuxarin ER and foods or non-alcoholic drinks.

Do not drink alcohol or use prescription or over-the-counter (OTC) medicines that contain alcohol. Using alcohol while taking Tuxarin ER can cause you to overdose and die.

Does Tuxarin ER interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Tuxarin ER.

  • A monoamine oxidase inhibitor (MAOI) within the past two weeks, which is a medicine usually used for depression or Parkinson’s disease
  • A benzodiazepine, such as clonazepam (Klonopin), diazepam (Valium and others), or lorazepam (Ativan and others), which is a medicine used for anxiety, muscle spasms, or seizures
  • A muscle relaxant, such as carisoprodol (Soma), cyclobenzaprine, metaxalone, or tizanidine (Zanaflex)
  • A macrolide antibiotic, such as clarithromycin or erythromycin (Ery-Tab and others), which is a medicine used for bacterial infections
  • Ketoconazole, itraconazole (Sporanox, Tolsura), posaconazole (Noxafil), fluconazole (Diflucan), or voriconazole (Vfend), which is a medicine used for fungal infections
  • A protease inhibitor, such as ritonavir (Norvir) or nelfinavir (Viracept), which is a medicine commonly used to treat HIV
  • Rifampin, which is a medicine commonly used to treat an infection called tuberculosis
  • Carbamazepine (Carbatrol, Tegretol, and others) or phenytoin (Dilantin, Phenytek, and others), which is a medicine used for seizures
  • A diuretic, also called a water pill, which is a medicine used to reduce edema (fluid retention) and blood pressure
  • An anticholinergic medicine, which includes antihistamines, such as diphenhydramine (Benadryl), and medicines commonly used for overactive bladder, Parkinson’s disease, or stomach problems
  • A cough suppressant, such as dextromethorphan
  • Any medicine that affects serotonin in your body, such as medicines for depression, anxiety, or certain mental health conditions, some migraine medicines, and some medicines for nausea and vomiting
  • Any other medicine that causes dizziness and sleepiness, such as prescription pain medicines, sleep medicines, and medicines for anxiety

Many other medicines may alter the blood levels of Tuxarin ER. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Tuxarin ER. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Tuxarin ER?

If you or someone else has used too much Tuxarin ER, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Tuxarin ER?

If you miss a dose, skip the missed dose and only take the next dose at your usual time. Do not take double or extra doses.