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Product Summary

PRESCRIPTION REQUIRED

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

BUTALBITAL/ACETAMINOPHEN/CAFFEINE - ORAL

(bue-TAL-bi-tal/a-SEET-a-MIN-oh-fen/KAF-een)

COMMON BRAND NAME(S): Esgic, Fioricet

WARNING: One ingredient in this product is acetaminophen. Taking too much acetaminophen may cause serious (possibly fatal) liver disease. Adults should not take more than 4000 milligrams (4 grams) of acetaminophen a day. If you have liver problems, consult your doctor or pharmacist for a safe dosage of this medication. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Avoid alcohol. Check with your doctor or pharmacist for more information. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting, stomach/abdominal pain, extreme tiredness, or yellowing eyes/skin. Acetaminophen is an ingredient found in many nonprescription products and in some combination prescription medications (such as pain/fever drugs or cough-and-cold products). Carefully check the labels on all your medicines because they may also contain acetaminophen. Ask your pharmacist about using those products safely. Get medical help right away if you have taken more than 4000 milligrams of acetaminophen a day, even if you feel well.

USES: This combination medication is used to treat tension headaches. Acetaminophen helps to decrease the pain from the headache. Caffeine helps increase the effects of acetaminophen. Butalbital is a sedative that helps to decrease anxiety and cause sleepiness and relaxation.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This medication may also be used to treat migraine headaches.

HOW TO USE: See also Warning section. Take this medication by mouth with or without food as directed by your doctor, usually every 4 hours as needed. If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. The dosage is based on your medical condition and response to treatment. This medication works best if it is used as the first signs of a headache occur. If you wait until the headache has worsened, the medication may not work as well. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as nausea/vomiting, mental/mood changes, seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Report any withdrawal reactions immediately. Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction. Tell your doctor if you notice increased use of this medication, a worsening of headaches, an increase in the number of headaches, the medication not working as well, or use of this medication for more than 2 headache episodes a week. Do not take more than recommended. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches.

SIDE EFFECTS: See also Warning section. Nausea, vomiting, abdominal pain, shaking (tremor), shortness of breath, increased urination, lightheadedness, dizziness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To reduce your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes, fainting, seizures, fast/irregular heartbeat. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section. Before taking this medication, tell your doctor or pharmacist if you are allergic to acetaminophen, caffeine, or butalbital; or to other barbiturates (such as phenobarbital) or xanthine derivatives (such as theophylline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe breathing problems (such as bronchopneumonia), a certain enzyme disorder (porphyria), liver disease, kidney disease, personal or family history of regular use/abuse of drugs/alcohol, mental/mood disorders, abdominal/stomach problems (such as stomach ulcer). This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Liquid products may contain alcohol, sugar and/or aspartame. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, seizures, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn. This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also Warning section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: sodium oxybate, drugs affecting liver enzymes that remove this medication from your body (such as macrolide antibiotics including erythromycin, cimetidine, disulfiram, valproic acid, fluvoxamine, MAO inhibitors including isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), isoniazid, lithium, phenothiazines (such as chlorpromazine). This drug can speed up the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs include "blood thinners" (such as warfarin), cyclosporine, doxycycline, estrogen, felodipine, metronidazole, quinidine, theophylline, certain beta blockers such as metoprolol, corticosteroids such as prednisone. Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as certain antihistamines (such as diphenhydramine), anti-seizure drugs (such as carbamazepine), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (such as codeine), psychiatric medicines (such as risperidone, amitriptyline, trazodone). Check the labels on all your medicines (such as cough-and-cold products) because they may contain caffeine or drowsiness-causing ingredients. Also keep in mind that certain beverages (such as coffee, colas, tea, energy drinks) contain caffeine. Ask your pharmacist about using those products safely. This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well. This medication may interfere with certain medical/laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, slow breathing, severe dizziness, persistent nausea/vomiting, unusual sweating.

NOTES: Do not share this medication with others. Massage, hot baths, and other relaxation methods can help with tension headaches. Consult your doctor or pharmacist for more details. Laboratory and/or medical tests (such as liver and kidney function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: Not applicable.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.