What key warnings should I know about before taking this medicine?

This medicine does not mix well with some medicines. Serious reactions may occur. Check all medicines with child's healthcare provider.

Reasons not to take this medicine

• If you have an allergy to butalbital, aspirin, caffeine, codeine, or any other part of this medicine.

• Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved.

• If you have any of the following conditions: Bleeding problems, nasal polyps, porphyria, or ulcer disease.

What is this medicine used for?

• This medicine is used to treat tension headaches.

How does it work?

• Butalbital calms the brain.

• Aspirin blocks production and release of chemicals that cause pain and inflammation.

• Caffeine relieves pain.

• Codeine binds to brain receptors, relieving pain. It decreases the feeling of pain and a person's response to pain.

How is it best taken?

• Take this medicine with food.

• Drink plenty of noncaffeine-containing liquid unless told to drink less liquid by healthcare provider.

What do I do if I miss a dose? (does not apply to patients in the hospital)

• Take a missed dose as soon as possible.

• Do not take a double dose or extra doses.

• Many times this medicine is taken on an as needed basis. Do not take more than 6 capsules per day.

What are the precautions when taking this medicine?

• This medicine may be habit-forming with long-term use.

• If you are 65 or older, use this medicine with caution. You could have more side effects.

• If you have lung disease, you may be more sensitive to this medicine.

• You may bleed more easily. Be careful. Avoid injury. Use soft toothbrush, electric razor.

• Check medicines with healthcare provider. This medicine may not mix well with other medicines.

• Talk with healthcare provider before using other aspirin-containing products, other pain medicines, blood thinners, garlic, ginseng, ginkgo, or vitamin E.

• Avoid alcohol (includes wine, beer, and liquor) or other medicines and natural products that slow your actions and reactions. These include sedatives, tranquilizers, mood stabilizers, antihistamines, and other pain medicine.

• You may not be alert. Avoid driving, doing other tasks or activities until you see how this medicine affects you.

• Birth control pills and other hormone-based birth control may not work to prevent pregnancy. Use another form of birth control while taking this medicine.

• Tell healthcare provider if you are pregnant or plan on getting pregnant.

• Tell healthcare provider if you are breast-feeding.

What are some possible side effects of this medicine?

• Feeling lightheaded, sleepy, having blurred vision, or a change in thinking clearly. Avoid driving, doing other tasks or activities that require you to be alert or have clear vision until you see how this medicine affects you.

• Feeling dizzy. Rise slowly over several minutes from sitting or lying position. Be careful climbing.

• Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help.

• Belly pain.

What should I monitor?

• Change in condition being treated. Is it better, worse, or about the same?

• Keep a diary of your headaches.

• Follow up with healthcare provider.

Reasons to call healthcare provider immediately

• If you suspect an overdose, call your local poison control center or emergency department immediately.

• Signs of a life-threatening reaction. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; or swelling of face, lips, tongue, or throat.

• Chest pain or pressure.

• Difficulty breathing.

• Significant change in balance.

• Significant change in thinking clearly and logically.

• Very nervous and excitable.

• Feeling extremely tired or weak.

• Unusual bruising or bleeding.

• Ringing in ears.

• Severe nausea or vomiting.

• Severe constipation.

• Any rash.

• No improvement in condition or feeling worse.

How should I store this medicine?

• Store at room temperature.

• Protect from light.

• Protect from moisture. Do not store in a bathroom or kitchen.

General statements

• If you have a life-threatening allergy, wear allergy identification at all times.

• Do not share your medicine with others and do not take anyone else's medicine.

• Keep all medicine out of the reach of children and pets.

• Most medicines can be thrown away in household trash after mixing with coffee grounds or kitty litter and sealing in a plastic bag.

• Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant).

• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or in Canada to Health Canada's Canada Vigilance Program at 1-866-234-2345.

• Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins.