Codeine has a risk for abuse and addiction, which can lead to overdose and death. Codeine may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of codeine that works, and take it for the shortest possible time. See also How to Use section for more information about addiction.
The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you take the wrong dose/strength. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Also, other medications can affect the removal of codeine from your body, which may affect how codeine works. Be sure you know how to take this medication and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.
Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this medication, get medical help right away.
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. People with liver problems and children should take less acetaminophen. Ask your doctor or pharmacist how much acetaminophen is safe to take.
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). Check the labels on all your medicines to see if they contain acetaminophen, and ask your pharmacist if you are unsure.
Get medical help right away if you take too much acetaminophen (overdose), even if you feel well. Overdose symptoms may include nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, and dark urine.
Daily alcohol use, especially when combined with acetaminophen, may damage your liver. Avoid alcohol.
Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn't stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.
Children younger than 12 years should not use products that contain codeine. Children between 12 and 18 years old should not use codeine after certain surgeries (including tonsil/adenoid removal). Also, codeine use is not recommended for children between 12 and 18 years old who are obese or have breathing problems. Some children are more sensitive to codeine and have had very serious (rarely fatal) breathing problems such as slow/shallow breathing (see also Side Effects section). Talk with your doctor or pharmacist about the risks and benefits of this medication.Who should not take BUTALB-CAFF-ACETAMINOPH-CODEIN?
See also Warning section.
This combination medication is used to treat tension headaches. Codeine is an opioid (narcotic) pain reliever that acts on certain centers in the brain to give you pain relief. Acetaminophen helps to decrease the pain from the headache. Caffeine helps increase the effects of acetaminophen. Butalbital is a sedative which helps to decrease anxiety and cause sleepiness and relaxation.
See also Warning section.
Take this medication by mouth with or without food, usually every 4 hours as needed or as directed by your doctor. Do not take more than 6 capsules in a 24-hour period. If you have nausea, you may take this medication with food. Ask your doctor or pharmacist about other ways to decrease nausea (such as lying down for 1-2 hours with as little head movement as possible).
The dosage is based on your medical condition, age, and response to therapy. 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.
Do not increase your dose or use this drug more often or for longer than prescribed, because your risk of side effects may increase. Properly stop the medication when so directed.
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 runny nose, watery eyes, mental/mood changes, seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.
Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.
Inform 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.
See also Warning section.
Nausea, vomiting, abdominal pain, shaking (tremor), shortness of breath, constipation, dry mouth, lightheadedness, dizziness, drowsiness, or trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).
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 you have any serious side effects, including: mental/mood changes, fast/irregular heartbeat, increased thirst/urination, signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, difficulty urinating, signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss).
Codeine is changed into a strong opioid drug (morphine) in your body. In some people, this change happens faster and more completely than usual, which increases the risk of very seriousside effects. Get medical help right away if you notice any of the following: slow/shallow breathing, severe drowsiness/difficulty waking up, confusion.
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 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
See also Warning section.
Before taking this medication, tell your doctor or pharmacist if you are allergic to acetaminophen, caffeine, codeine, or butalbital; or to other barbiturates (e.g., phenobarbital), xanthine derivatives (e.g., theophylline) or opioid pain medications (e.g., morphine); 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: a certain enzyme disorder (porphyria), brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), breathing problems (e.g., asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), disease of the pancreas (e.g., pancreatitis), heart disease (e.g., irregular heartbeat, recent heart attack), liver disease, kidney disease, a certain spinal problem (kyphoscoliosis), gallbladder disease, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), mental/mood disorders, obesity, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus, stomach ulcer, colitis), adrenal gland problem (e.g., Addison's disease), difficulty urinating (e.g., due to enlarged prostate or urethral stricture), underactive thyroid (hypothyroidism), recent bowel/abdominal surgery.
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), tell your doctor or dentist that you use this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Some children may be more sensitive to very serious side effects of the codeine in this product, such as extreme sleepiness, confusion, or slow/shallow/noisy breathing. (See also Warning section.)
Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, slow/shallow breathing, and trouble falling asleep. Confusion, dizziness, drowsiness, and trouble falling asleep can increase the risk of falling.
During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.
This medication passes into breast milk and may rarely have undesirable effects on a nursing infant, such as unusual sleepiness, difficulty feeding, trouble breathing, or unusual limpness. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
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.
Some products that may interact with this drug include: anticholinergic medications (e.g., scopolamine), darunavir, drugs affecting liver enzymes that remove this medication from your body (such as cimetidine, disulfiram, valproic acid, fluvoxamine), isoniazid, lithium, MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine), methoxyflurane, naltrexone, other medications for pain (e.g., pentazocine, nalbuphine, morphine), phenothiazines (e.g., chlorpromazine), sodium oxybate.
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), corticosteroids (such as prednisone), estrogen, felodipine, quinidine, certain beta-blockers (such as metoprolol), theophylline, doxycycline.
The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as morphine, hydrocodone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).
Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain caffeine or ingredients that cause drowsiness. Certain beverages (such as coffee, colas, tea) may also contain caffeine. Ask your pharmacist about using those products safely.
Other medications can affect the removal of this product from your body, which may affect how this product works. Examples include azole antifungals (such as ketoconazole), bupropion, fluoxetine, macrolide antibiotics (such as erythromycin), HIV medications (such as ritonavir), paroxetine, quinidine, rifamycins (such as rifabutin, rifampin), certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others.
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 (including urine 5-HIAA levels, urine VMA levels, urine catecholamine levels, amylase and lipase levels, dipyridamole-thallium imaging tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, give them naloxone if available, then call 911. If the person is awake and has no symptoms, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness/dizziness, slow/shallow breathing, very small pupils, nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, dark urine, coma.
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.Information last revised July 2017. Copyright(c) 2017 First Databank, Inc.
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