Aspirin, butalbital, and caffeine is a combination medicine used to treat symptoms of tension (muscle contraction) headaches. aspirin, butalbital, and caffeine is not for treating multiple headaches that come and go.

Aspirin, butalbital, and caffeine may also be used for purposes not listed in this medication guide.

aspirin, butalbital, and caffeine may be habit-forming. Misuse can cause addiction, overdose, or death.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the lowest effective dose for your condition.

Butalbital may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication where others cannot get to it. Selling or giving away aspirin, butalbital, and caffeine is against the law.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using aspirin, butalbital, and caffeine.

This medicine is usually prescribed for short-term use only. You may have withdrawal symptoms if you stop using the medicine suddenly after long-term use. Ask your doctor before stopping the medicine.

Store tightly closed at room temperature, away from moisture, heat, and light. Keep your medicine in a place where no one can use it improperly.

Usual Adult Dose for Pain:

1 or 2 capsules orally every 4 hours as needed not to exceed 6 capsules per day

Comments:
-Due to high rate of physical dependence, the extended use of this drug is not recommended.
-The safety and efficacy of treating multiple recurrent headaches with this product is not known.

Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

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

• a bleeding or blood clotting disorder such as hemophilia, von Willebrand's disease, low platelets;

• severe vitamin K deficiency;

• severe liver disease;

• a severe allergic reaction (sneezing, runny or stuffy nose, wheezing) after taking aspirin or another NSAID (nonsteroidal anti-inflammatory drug) such as ibuprofen, celecoxib, diclofenac, indomethacin, meloxicam, naproxen, Advil, Motrin, Aleve, and others;

• a stomach ulcer; or

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

Not approved for use by anyone younger than 18 years old. Using this medicine in a child or teenager with flu symptoms or chickenpox can cause a serious or fatal condition called Reye's syndrome.

Tell your doctor if you have ever had:

• liver or kidney disease;

• bleeding problems;

• a head injury or brain tumor;

• a stomach or intestinal disorder;

• underactive thyroid;

• allergies;

• an enlarged prostate or urination problems; or

• Addison's disease (an adrenal gland disorder).

Do not use this medicine during pregnancy unless your doctor tells you to. Using butalbital during pregnancy may cause withdrawal symptoms in the newborn. Using aspirin in the last 20 weeks can harm the unborn baby or cause pregnancy complications.

Do not breastfeed.

This medicine is used when needed. If you are on a dosing schedule, skip any missed dose. Do not use two doses at one time.

Do not take more than 6 tablets or capsules in 24 hours.

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

Overdose may cause severe drowsiness, confusion, feeling restless, insomnia, tremors, fast or pounding heartbeats, vomiting, stomach pain, rapid breathing, feeling hot, ringing in your ears, weak or shallow breathing, bruising or bleeding, seizure (convulsions), fainting, or coma.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Aspirin, butalbital, and caffeine may cause an upset stomach. Take this medicine with food or milk.

Avoid driving or hazardous activity until you know how aspirin, butalbital, and caffeine will affect you. Your reactions could be impaired.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to aspirin (such as ibuprofen, ketoprofen, or naproxen).

Avoid drinking alcohol.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop taking this medicine and seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Aspirin, butalbital, and caffeine may cause serious side effects. Call your doctor at once if you have:

• bloody or tarry stools;

• coughing up blood or vomit that looks like coffee grounds; or

• any bleeding that will not stop.

Common side effects of aspirin, butalbital, and caffeine may include:

• drowsiness; or

• 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.

Using this medicine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• mercaptopurine;

• methotrexate;

• probenecid;

• a blood thinner such as warfarin, Coumadin, Jantoven;

• insulin or oral diabetes medicine;

• steroid medicine such as prednisone;

• an MAO inhibitor--isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others; or

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

This list is not complete. Other drugs may affect aspirin, butalbital, and caffeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor.

Do not let anyone else take your medication. This medication is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.