Butalbital/acetaminophen/caffeine (By mouth)

Introduction

Acetaminophen (a-seet-a-MIN-oh-fen), Butalbital (bue-TAL-bi-tal), Caffeine (KAF-een)

Treats tension (or muscle contraction) headaches. This medicine contains a barbiturate.

Brand Name(s)

Fioricet, Esgic-Plus, Dolgic Plus, Orbivan, Esgic, Pacaps, Anolor 300, Alagesic, Capacet, Margesic, Zebutal, Alagesic LQ, Nonbac, Repan

When This Medicine Should Not Be Used

How to Use This Medicine

Capsule, Liquid, Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This combination medicine contains acetaminophen (Tylenol(R)). Carefully check the labels of all other medicines you are using because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• Take this medicine with food or milk if it upsets your stomach.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using an MAO inhibitor (such as Eldepryl®, Marplan®, Nardil®, or Parnate®) or a tranquilizer (such as chlordiazepoxide or Librium®).
• Many combination medicines contain acetaminophen, including products with brand names such as Alka-Seltzer Plus®, Comtrex®, Drixoral®, Excedrin Migraine®, Midol®, Sinutab®, Sudafed®, Theraflu®, and Vanquish®. Carefully check the labels of all other medicines you are using to be sure they do not contain acetaminophen.
• Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
• Do not drink alcohol while you are using this medicine. Large doses of acetaminophen can damage your liver. Alcohol can also increase this risk. Tell your doctor if you drink 3 or more alcoholic drinks a day.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney or liver disease, or a stomach disorder. Tell your doctor if you have a history of alcohol or drug abuse.
• This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
• Tell your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, or yellow eyes or skin. These could be symptoms of a serious liver problem.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Long-term use of this medicine is not recommended.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Dark-colored urine or pale stools
• Nausea, vomiting, loss of appetite, or pain in the upper stomach
• Trouble breathing
• Unusual bleeding, bruising, or weakness
• Yellowing of your skin or the whites of your eyes

If you notice these less serious side effects, talk with your doctor:

• Confusion, trouble concentrating, unsteadiness
• Mild dizziness, sleepiness, or tiredness
• Mild nausea, vomiting
• Rapid heartbeat, irritability, or tremors

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088