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What is APAP/butalbital/caffeine/codeine?

Codeine is in a group of drugs called narcotic pain relievers.

Acetaminophen is a less potent pain reliever that increases the effects of codeine.

Butalbital is in a group of drugs called barbiturates. 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.

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

Acetaminophen, butalbital, caffeine, and codeine may also be used for purposes other than those listed in this medication guide.

Precautions

Instructions

Side Effects

Interactions

Precautions

Do not use this medication if you are allergic to acetaminophen (Tylenol) or codeine, or if you have porphyria.

Codeine and butalbital may be habit-forming and should be used only by the person it was prescribed for. This medication should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have:

• asthma, COPD, sleep apnea, or other breathing disorders;
• liver or kidney disease;
• a history of head injury or brain tumor;
• low blood pressure;
• a stomach or intestinal disorder;
• curvature of the spine;
• mental illness; or
• a history of drug or alcohol addiction.

If you have any of these conditions, you may not be able to use acetaminophen, butalbital, caffeine, and codeine, or you may need a dosage adjustment or special tests during treatment.

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Acetaminophen, butalbital, caffeine, and codeine 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. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more sensitive to the effects of this medicine.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Do not use any other cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP”) is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP.

Avoid drinking alcohol while taking acetaminophen, butalbital, caffeine, and codeine. Alcohol may increase your risk of liver damage while taking acetaminophen.

While you are taking this medication, avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of acetaminophen, butalbital, caffeine, and codeine can be fatal.

Overdose symptoms may include extreme drowsiness or insomnia, restless feeling, tremors, fast heart rate, sweating, pinpoint pupils, nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes), confusion, fainting, weak pulse, coma, blue lips, shallow breathing, or no breathing.

Since acetaminophen, butalbital, caffeine, and codeine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

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Side Effects

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

Call your doctor at once if you have any of these serious side effects:

• shallow breathing, slow heart rate;
• fast or pounding heart rate, feeling short of breath;
• feeling light-headed, fainting;
• confusion, unusual thoughts or behavior;
• muscle twitching;
• easy bruising or bleeding; or
• nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects include:

• feeling dizzy or drowsy, shaky or agitated;
• mild nausea, vomiting, upset stomach, constipation, diarrhea;
• increased appetite;
• mood changes, sleep problems (insomnia);
• sweating, urinating more than usual;
• blurred vision; or
• dry mouth.

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 report side effects to FDA at 1-800-FDA-1088.

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Interactions

Before taking this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by butalbital or codeine.

Also tell your doctor if you are using any of the following drugs:

• glycopyrrolate (Robinul);
• mepenzolate (Cantil);
• ciprofloxacin (Cipro);
• atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
• bladder or urinary medications such as darifenacin (Enablex), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
• a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva);
• irritable bowel medications such as dicyclomine (Bentyl) or hyoscyamine (Anaspaz, Cystospaz, and others); or
• an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

This list is not complete and there may be other drugs that can interact with acetaminophen, butalbital, caffeine, and codeine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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