Aspirin, ASA; Butalbital; Caffeine tablets and capsules

What is this medicine?

ASPIRIN; BUTALBITAL; CAFFEINE (AS pir in; byoo TAL bi tal; KAF een) is a pain reliever. It is used to treat tension headaches.

How should I use this medicine?

Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. If the medicine upsets your stomach, take the medicine with food or milk. Do not take more than you are told to take.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. Caution should be used in children, especially teenagers, that have the chicken pox or flu.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• confusion

• feeling faint or lightheaded, falls

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• dizziness

• drowsiness

• nausea, vomiting

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• alcohol or medicines that contain alcohol

• cidofovir

• furazolidone

• methotrexate

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• probenecid

• procarbazine

• voriconazole

• warfarin

This medicine may also interact with the following medications:

• antidepressants

• antihistamines

• benzodiazepines

• heparin and heparin like drugs including enoxaparin, dalteparin, and tinzaparin

• medicines for pain

• muscle relaxants

• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

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 medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

This medicine may cause accidental overdose and death if it taken by other adults, children, or pets. Mix any unused medicine with a substance like cat litter or coffee grounds. Then throw the medicine away in a sealed container like a sealed bag or a coffee can with a lid. Do not use the medicine after the expiration date.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F).

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• drink more than 3 alcohol containing drinks per day

• drug abuse or addiction

• heart or circulation problems

• hemophilia, von Willebrand's disease, low platelets, or other bleeding problems

• kidney disease or problems going to the bathroom

• liver disease

• lung disease like asthma or emphysema

• peptic ulcer disease

• porphyria

• an unusual or allergic reaction to aspirin or salicylates, butalbital or other barbiturates, caffeine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Tell your doctor or health care professional 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 medicine. Tolerance means that you will need a higher dose of the medicine for pain relief. Tolerance is normal and is expected if you take the medicine for a long time.

Do not suddenly stop taking your medicine because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a non-medical reason. If you have pain, you have a medical reason to take pain medicine. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

You may get drowsy or dizzy when you first start taking the medicine or change doses. Do not drive, use machinery, or do anything that may be dangerous until you know how the medicine affects you. Stand or sit up slowly.

Too much aspirin can be very dangerous. Do not take aspirin or medicines that contain aspirin with this medicine. Many non-prescription medicines contain aspirin. Always read the labels carefully.