Learn more about usage, cautions, and possible side effects .
Chemical Name: BUTALBITAL (byoo-TAL-bi-tal), ASPIRIN (AS-pir-in), CAFFEINE (kaf-EEN), and CODEINE (KOE-deen)
This medicine is an analgesic, barbiturate, and stimulant combination used to treat tension headaches.
Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE IF you are taking sodium oxybate (GHB). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anticoagulants (eg warfarin), celecoxib, clopidogrel, heparin, NSAIDs (eg, ibuprofen), benzodiazepines (eg, chlordiazepoxide), cimetidine, HIV protease inhibitors (eg, ritonavir), monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), narcotic analgesics (eg, morphine), sleeping medicines (eg, temazepam), naltrexone, carbonic anhydrase inhibitors (eg, acetazolamide), insulin, meglitinides (eg, repaglinide), methotrexate, quinolone antibiotics (eg, ciprofloxacin), valproic acid, angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril), antipsychotics (eg, clozapine), beta-blockers (eg, atenolol), corticosteroids (eg, prednisone), doxycycline, estrogens (eg, estradiol), metronidazole, oral contraceptives (eg, birth control pills), probenecid, quinidine, sulfinpyrazone, theophylline, or tricyclic antidepressants (eg, amitriptyline). DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including asthma, stomach or intestinal problems (eg, inflammatory bowel disease), liver problems, the flu, nasal polyps, kidney problems, lung or respiratory tract disease, an enlarged prostate, severe heart disease, difficulty urinating, chickenpox, underactive thyroid, vitamin K deficiency, very poor health, allergies, pregnancy, or breast-feeding. Tell your doctor if you have a history of stroke, head injury, growths in the brain, anxiety, substance abuse or dependence, depression, or suicidal thoughts or behaviors. Tell your doctor if you will be having stomach or intestinal surgery. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have von Willebrand disease, the blood disease porphyria, severe stomach or intestinal problems (eg, peptic ulcer, pseudomembranous colitis), blood clotting problems (eg, hemophilia), severe bleeding, severe liver damage, or severe low levels of vitamin K. USE OF THIS MEDICINE IS NOT RECOMMENDED if the patient is a child or teenager who has the flu, chickenpox, or joint problems. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
Follow the directions for using this medicine provided by your doctor. TAKE THIS MEDICINE with food or milk. STORE THIS MEDICINE at room temperature in a tightly-closed container, away from heat and light. IF YOU MISS A DOSE OF THIS MEDICINE and you are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
DO NOT TAKE THIS MEDICINE IF YOU HAVE HAD A SEVERE ALLERGIC REACTION to aspirin or any medicine containing aspirin. DO NOT TAKE THIS MEDICINE IF YOU HAVE HAD A SEVERE ALLERGIC REACTION to codeine, hydrocodone, dihydrocodeine, or oxycodone (such as Tylox, Tylenol with Codeine, Vicodin). A severe allergic reaction includes a severe rash, hives, breathing difficulties, or dizziness. If you have a question about whether you are allergic to this medicine or if a certain medicine contains codeine, hydrocodone, dihydrocodeine, or oxycodone, contact your doctor or pharmacist. IF YOU EXPERIENCE difficulty breathing; tightness of chest; swelling of eyelids, face, or lips; or if you develop a rash or hives, tell your doctor immediately. Do not take any more doses of this medicine unless your doctor tells you to do so. DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit-forming. AVOID ALCOHOL while you are using this medicine. This medicine will add to the effects of alcohol and other depressants. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. THIS MEDICINE CONTAINS ASPIRIN which has been linked to Reye's syndrome. DO NOT GIVE THIS MEDICINE TO CHILDREN OR TEENAGERS during or after chickenpox, flu, or other viral infection without checking with your doctor, nurse, or pharmacist for more information. THIS MEDICINE MAY CAUSE stomach bleeding. If you drink alcohol on a daily basis, do not take this medicine without first discussing it with your doctor. Alcohol use combined with this medicine may increase your risk for stomach bleeding. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. FOR WOMEN TAKING BIRTH CONTROL PILLS, this medicine may decrease the effectiveness of your birth control pills. To prevent pregnancy, use an additional form of birth control. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. THIS MEDICINE IS EXCRETED IN BREAST MILK. DO NOT BREAST-FEED while taking this medicine.
SIDE EFFECTS that may occur while taking this medicine include dizziness; drowsiness; gas; indigestion; lightheadedness; nausea; or stomach pain. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you notice black or bloody stools; confusion; severe drowsiness; shallow breathing; or unusual bruising or bleeding. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; or swelling of the mouth, face, lips, or tongue. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. Check drug interactions
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include unusual drowsiness or dizziness, nausea, vomiting, stomach pain, ringing in the ears, weakness, slow or shallow breathing, fast or irregular heartbeat, and loss of consciousness.
IF YOUR HEADACHE SYMPTOMS do not improve or if they become worse, contact your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.
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