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One ingredient in this product is acetaminophen. People with liver problems and children should take less 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. Ask your doctor or pharmacist how much acetaminophen is safe to take.
This product may contain inactive ingredients, which can cause allergic reactions or other problems. Before taking this medication, l 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. Talk to your pharmacist for more details.
Report any withdrawal reactions right away. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. To prevent withdrawal reactions, your doctor may reduce your dose gradually. In such cases, withdrawal symptoms (such as nausea/vomiting, mental/mood changes, seizures ) may occur if you suddenly stop using this medication.
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.
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Do not share this medication with others.
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A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else.
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You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. Call your doctor for medical advice about side effects.
Consult your doctor or pharmacist for more details. Massage, hot baths, and other relaxation methods can help with tension headaches.
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This medication works best if it is used as the first signs of a headache occur. The dosage is based on your medical condition, age, and response to treatment. If you wait until the headache has worsened, the medication may not work as well.
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.
Some products that may interact with this drug include: darunavir, 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).
Older adults may be more sensitive to the side effects of this drug, especially drowsiness and trouble falling asleep. These side effects can increase the risk of falling.
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Overdose symptoms may include nausea, vomiting, loss of appetite, sweating, stomach / abdominal pain, extreme tiredness, yellowing eyes / skin, and dark urine. Get medical help right away if you take too much acetaminophen (overdose), even if you feel well.
Do not take more than recommended. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches. l 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.
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.
Canada residents can call a provincial poison control center. US residents can call their local poison control center at. Symptoms of overdose may include: severe drowsiness, slow/shallow breathing, severe dizziness, nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, dark urine. If overdose is suspected, contact a poison control center or emergency room right away.
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In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at.
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Consult your pharmacist or local waste disposal company. 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.
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.
Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior ( addiction ). Take this medication exactly as prescribed to lessen the risk of addiction. This risk may be increased if you have abused alcohol or drugs in the past.
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Check the labels on all your medicines (such as cough-and-cold products) because they may contain caffeine or drowsiness-causing ingredients. Ask your pharmacist about using those products safely. Also keep in mind that certain beverages (such as coffee, colas, tea, energy drinks) contain caffeine.
Daily alcohol use, especially when combined with acetaminophen, may damage your liver. Avoid alcohol.
See also Warning section.
Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. This could cause pregnancy. This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. Also l your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.
Make sure laboratory personnel and all your doctors know you use this drug. This medication may interfere with certain medical/laboratory tests, possibly causing false test results.
l 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).
Take this medication by mouth with or without food as directed by your doctor, usually every 4 hours as needed.
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Before having surgery or certain medical procedures (such as a heart stress test or a procedure to restore a normal heart rhythm if you have an unusually fast heartbeat), l your doctor or dentist that you use this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Nausea, vomiting, abdominal pain, constipation, dry mouth, shaking (tremor), shortness of breath, increased urination, lightheadedness, dizziness, drowsiness, or trouble sleeping may occur. If any of these effects persist or worsen, l your doctor or pharmacist promptly.
2016 First Databank, Inc. Information last revised March 2016.
This document does not contain all possible drug interactions. Drug interactions may change how your medications work or increase your risk for serious side effects. 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.
To reduce your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Before using this medication, l 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 ).
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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. Not applicable. Consult your doctor for more details.
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. Liquid products may contain alcohol, sugar and/or aspartame.
This medication may also be used to treat migraine headaches.
In the US.
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.
Check the labels on all your medicines to see if they contain acetaminophen, and ask your pharmacist if you are unsure. Do not use with any other drug containing acetaminophen without asking your doctor or pharmacist first. Acetaminophen is in many nonprescription and prescription medications (such as pain/fever drugs or cough -and-cold products).
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If you notice other effects not listed above, contact your doctor or pharmacist. This is not a complete list of possible side effects.
See also Warning section.
Acetaminophen helps to decrease the pain from the headache. Caffeine helps increase the effects of acetaminophen. This combination medication is used to treat tension headaches. Butalbital is a sedative that helps to decrease anxiety and cause sleepiness and relaxation.
This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
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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. l your doctor right away if you notice any of these symptoms in your newborn. During pregnancy, this medication should be used only when clearly needed. 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.
Keep all medications away from children and pets. Store at room temperature away from light and moisture. Do not store in the bathroom.
See also Warning section.
l your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes, fainting, seizures, fast/ irregular heartbeat.
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), doxycycline, estrogen, felodipine, quinidine, theophylline, certain beta blockers such as metoprolol, corticosteroids such as prednisone.Fioricet