Fioricet is available as hard-gelatin capsules for oral administration. Each capsule contains the active ingredients Butalbital (50 mg), Acetaminophen (300 mg), and Caffeine (40 mg). Butalbital is a barbiturate, Acetaminophen is an analgesic and antipyretic, and Caffeine is a central nervous system stimulant. Key inactive ingredients include FD&C blue # 1, gelatin, and microcrystalline cellulose.

How should I use this medication?

Take this medication by mouth with a full glass of water. Follow the directions on the prescription label. If the medication upsets your stomach, take the medication with food or milk. Do not take more than you are told to take. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children. This medication can be abused. Keep your medication in a safe place to protect it from theft. Do not share this medication with anyone. Selling or giving away this medication is dangerous and against the law. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it or it is expired. You can do this in two ways: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake -Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue -Redness, blistering, peeling, or loosening of the skin, including inside the mouth Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Dizziness -Drowsiness -Nausea -Stomach pain -Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Frequently drink alcohol -Heart or circulation problems -Kidney disease or trouble passing urine -Liver disease -Lung or breathing disease, such as asthma -Porphyria -Substance use disorder -An unusual or allergic reaction to acetaminophen, butalbital or other barbiturates, caffeine, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

-Alcohol or medications that contain alcohol -Antidepressants, especially MAOIs, such as isocarboxazid, phenelzine, tranylcypromine, selegiline -Antihistamines -Benzodiazepines -Carbamazepine -Isoniazid -Medications for pain, such as pentazocine, buprenorphine, butorphanol, nalbuphine, tramadol, propoxyphene -Muscle relaxants -Naltrexone -Phenobarbital, phenytoin, and fosphenytoin -Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine -Voriconazole

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to the medication. Tolerance means that you will need a higher dose of the medication for pain relief. Tolerance is normal and is expected if you take the medication for a long time. Do not suddenly stop taking your medication because you may develop a severe reaction. Your body becomes used to the medication. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a medication for a non-medical reason. If you have pain, you have a medical reason to take pain medication. Your care team will tell you how much medication to take. If your care team wants you to stop the medication, the dose will be slowly lowered over time to avoid any side effects. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects. Do not take other medications that contain acetaminophen with this medication. Always read labels carefully. If you have questions, ask your care team or pharmacist. If you take too much acetaminophen, get medical help right away. Too much acetaminophen can be very dangerous and cause liver damage. Even if you do not have symptoms, it is important to get help right away.

What are the most serious risks of this medication?

This medication has acetaminophen in it. Taking too much acetaminophen can cause serious liver injury and death. It is important that you do not take more than 4,000 mg of acetaminophen in one day. Many medications for pain and fever contain acetaminophen. It is important to check package labels. Do not take more than one medication that has acetaminophen in it at the same time. Talk to your care team about all the medications you take, both prescription and over-the-counter. They can help you make sure you are not taking too much. Liver problems and alcohol use while taking acetaminophen can increase the risk of liver injury. Seek medical help right away if you think you have taken too much acetaminophen. It is important even if you do not have symptoms. Symptoms of liver injury include feeling weak or tired, pain in the right upper side of the belly, loss of appetite, nausea, and yellowing of the skin or eyes.