BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE (byoo TAL bi tal; AS pir in; KAF een; KOE deen) is a pain reliever. It is used to treat tension headaches.
Butalbital, Aspirin, Caffeine, Codeine Phosphate may be used for other purposes; ask your health care provider or pharmacist if you have questions
Take this medicine by mouth. Swallow it with a full glass of water. Follow the directions on the prescription label. If the medicine upsets your stomach, take the medicine with food or milk. Do not take more than you are told to take.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. This medicine is not for use in children less than 12 years of age. Do not give this medicine to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
Overdosage: If you think you have taken too much of Butalbital, Aspirin, Caffeine, Codeine Phosphate contact a poison control center or emergency room at once. NOTE: Butalbital, Aspirin, Caffeine, Codeine Phosphate is only for you. Do not share Butalbital, Aspirin, Caffeine, Codeine Phosphate with others.
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
Side effects that you should report to your doctor or health care provider as soon as possible:
-allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
-bleeding (bloody or black, tarry stools; red or dark brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eyes, gums, or nose
-decreased hearing, ringing of the ears
-fast, irregular heartbeat
-kidney injury (trouble passing urine or change in the amount of urine)
-low adrenal gland function (nausea; vomiting; loss of appetite; unusually weak or tired; dizziness; low blood pressure)
-low blood pressure (dizziness; feeling faint or lightheaded, falls; unusually weak or tired)
-rash, fever, and swollen lymph nodes
-redness, blistering, peeling or loosening of the skin, including inside the mouth
-serotonin syndrome (irritable; confusion; diarrhea; fast or irregular heartbeat; muscle twitching; stiff muscles; trouble walking; sweating; high fever; seizures; chills; vomiting)
Side effects that usually do not require medical attention (report to your doctor or health care provider if they continue or are bothersome):
This list may not describe all possible side effects for Butalbital, Aspirin, Caffeine, Codeine Phosphate. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Do not take this medicine with any of the following medications:
This medicine may also interact with the following medications:
-antihistamines for allergy, cough and cold
-certain medicines for anxiety or sleep
-certain medicines for bladder problems like oxybutynin, tolterodine
-certain medicines for blood pressure, heart disease, irregular heart beat
-certain medicines for depression like amitriptyline, fluoxetine, sertraline
-certain medicines for Parkinson''s disease like benztropine, trihexyphenidyl
-certain medicines for seizures like phenobarbital, primidone
-certain medicines for stomach problems like dicyclomine, hyoscyamine
-certain medicines for travel sickness like scopolamine
-certain medicines that treat or prevent blood clots like warfarin, enoxaparin, dalteparin, apixaban, dabigatran, and rivaroxaban
-general anesthetics like halothane, isoflurane, methoxyflurane, propofol
-local anesthetics like lidocaine, pramoxine, tetracaine
-MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
-medicines that relax muscles for surgery
-NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
-other aspirin and aspirin-like medicines
-other narcotic medicines for pain or cough
-phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
They need to know if you have any of these conditions:
-drug abuse or addiction
-hemophilia, von Willebrand''s disease, low platelets, or other bleeding problems
-if you often drink alcohol
-lung disease, asthma, or breathing problems
-stomach or intestinal problems
-taken an MAOI like Marplan, Nardil, or Parnate in the last 14 days
-an unusual or allergic reaction to aspirin or salicylates, butalbital or other barbiturates, caffeine, codeine or other opioid analgesics, other medicines, foods, dyes, or preservatives
-pregnant or trying to get pregnant
Tell your health care provider if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to this medicine. Tolerance means that you will need a higher dose of the medicine for pain relief. Tolerance is normal and is expected if you take this medicine for a long time.
Do not suddenly stop taking your medicine because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a medicine for a nonmedical reason. If you have pain, you have a medical reason to take pain medicine. Your health care provider will tell you how much medicine to take. If your health care provider wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.
If you take other medicines that also cause drowsiness like other narcotic pain medicines, benzodiazepines, or other medicines for sleep, you may have more side effects. Give your health care provider a list of all medicines you use. He or she will tell you how much medicine to take. Do not take more medicine than directed. Get emergency help right away if you have trouble breathing or are unusually tired or sleepy.
Talk to your health care provider about naloxone and how to get it. Naloxone is an emergency medicine used for an opioid overdose. An overdose can happen if you take too much opioid. It can also happen if an opioid is taken with some other medicines or substances, like alcohol. Know the symptoms of an overdose, like trouble breathing, unusually tired or sleepy, or not being able to respond or wake up. Make sure to tell caregivers and close contacts where it is stored. Make sure they know how to use it. After naloxone is given, you must get emergency help right away. Naloxone is a temporary treatment. Repeat doses may be needed.
This medicine will cause constipation. If you do not have a bowel movement for 3 days, call your health care provider.
Check with your health care provider if you have severe diarrhea, nausea, and vomiting, or if you sweat a lot. The loss of too much body fluid may make it dangerous for you to take this medicine.
Do not take other medicines that contain aspirin, ibuprofen, or naproxen with this medicine. Side effects such as stomach upset, nausea, or ulcers may be more likely to occur. Many non-prescription medicines contain aspirin, ibuprofen, or naproxen. Always read labels carefully.
This medicine can cause serious ulcers and bleeding in the stomach. It can happen with no warning. Smoking, drinking alcohol, older age, and poor health can also increase risks. Call your health care provider right away if you have stomach pain or blood in your vomit or stool.
This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your health care provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.
Talk to your health care provider if you are pregnant before taking this medicine. Taking this medicine between weeks 20 and 30 of pregnancy may harm your unborn baby. Your health care provider will monitor you closely if you need to take it. After 30 weeks of pregnancy, do not take this medicine.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effects of this medicine. Avoid alcoholic drinks.
Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your health care provider if the problem does not go away or is severe.
Keep out of the reach of children and pets.
This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.
This medicine may cause accidental overdose and death if it is taken by other adults, children, or pets.
Store at room temperature below 25 degrees C (77 degrees F).
Get rid of any unused medicine after the expiration date.
To get rid of medicines that are no longer needed or have expired:
-Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
-If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.