Ascomp with Codeine

Generic Name: aspirin, butalbital, caffeine, and codeine (AS pir in, bue TAL bi tal, KAF een, and KOE deen)
Brand Name: Ascomp with Codeine, Fiorinal with Codeine

What is Ascomp with Codeine (aspirin, butalbital, caffeine, and codeine)?

Aspirin is a salicylate (sa-LIS-il-ate). It works by reducing substances in the body that cause pain, fever, and inflammation.

Butalbital is a barbiturate. It relaxes muscle contractions involved in a tension headache.

Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

Codeine is an opioid pain medication. An opioid is sometimes called a narcotic.

Aspirin, butalbital, caffeine, and codeine is a combination medicine used to treat tension headaches. This medicine is not for treating headaches that come and go.

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

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

Aspirin may cause stomach or intestinal bleeding, which can be fatal.

You should not use this medication if you have a bleeding or blood clotting disorder, low levels of platelets in blood, nasal polyps, a stomach or intestinal disorder, or porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).

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Medicines that contain codeine should not be given to a child just after surgery to remove the tonsils or adenoids.

Get emergency medical help if a child taking this medication has breathing problems, blue lips, or severe drowsiness, or if you cannot wake the child up from sleep.

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

Aspirin may cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are taking this medicine.

You should not use this medication if you are allergic to aspirin, butalbital, caffeine, or codeine, or if you have:

  • a bleeding or blood clotting disorder;

  • low levels of platelets in blood;

  • liver disease;

  • a severe vitamin K deficiency;

  • nasal polyps;

  • a stomach or intestinal disorder;

  • porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system); or

  • an allergy to an NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

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.

Medicines that contain codeine should not be given to a child just after surgery to remove the tonsils or adenoids.

To make sure this medicine is safe for you, tell your doctor if you have:

  • asthma, COPD, sleep apnea, or other breathing disorders;

  • kidney disease;

  • heart disease;

  • a history of head injury or brain tumor;

  • a thyroid disorder;

  • an enlarged prostate or urination problems;

  • Addison's disease or other adrenal gland disorder; or

  • a history of drug or alcohol addiction.

FDA pregnancy category C. Codeine and butalbital may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Taking aspirin during late pregnancy may cause bleeding in the mother or the baby during delivery. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

This medication can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Aspirin use while breast-feeding could cause bleeding in the infant. Do not breast-feed while taking this medicine.

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children.

Serious side effects may be more likely in older adults and those who are ill or debilitated.

How should I take this medicine?

Follow all directions on your prescription label. Codeine can slow or stop your breathing. Never use aspirin, butalbital, caffeine, and codeine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your headaches.

Butalbital and codeine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away aspirin, butalbital, caffeine, and codeine is against the law.

Do not stop using this medicine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using aspirin, butalbital, caffeine, and codeine.

If you need surgery or medical tests, tell the surgeon ahead of time that you are using this medicine. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Butalbital and codeine are drugs of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since this medicine 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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of butalbital or codeine can be fatal.

Overdose symptoms may include severe drowsiness or insomnia, tremors, pinpoint pupils, vomiting, dark urine, jaundice (yellowing of the skin or eyes), confusion, ringing in your ears, fainting, weak pulse, seizure (convulsions), blue lips, shallow breathing, or no breathing.

What should I avoid while taking this medicine?

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how the medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Many medicines available over the counter contain aspirin or similar medicines. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

This medicine side effects

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

Seek emergency medical attention if a child taking this medication has any of the following life-threatening side effects: noisy breathing, sighing, slow breathing with long pauses between breaths; being unusually sleepy or hard to wake up; blue colored lips.

Call your doctor at once if you have:

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

  • fast or pounding heart rate, muscle twitching;

  • confusion, unusual thoughts or behavior;

  • little or no urinating;

  • symptoms of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or

  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects include:

  • nausea, stomach pain;

  • drowsiness; or

  • mild dizziness.

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.

See also: Side effects (in more detail)

What other drugs will affect Ascomp with Codeine (aspirin, butalbital, caffeine, and codeine)?

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking this medicine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with aspirin, butalbital, caffeine, and codeine, especially:

  • medication to prevent blood clots--dalteparin, desirudin, enoxaparin, fondaparinux, tinzaparin, warfarin, Coumadin; or

  • an NSAID (nonsteroidal anti-inflammatory drug)--ibuprofen (Advil, Motrin), ketorolac.

This list is not complete. Other drugs may interact with aspirin, butalbital, caffeine, and codeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

More about Ascomp with Codeine (aspirin / butalbital / caffeine / codeine)

Consumer resources

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Where can I get more information?

  • Your pharmacist can provide more information about aspirin, butalbital, caffeine, and codeine.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 9.04. Revision Date: 2014-01-29, 11:05:27 AM.

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