Acetaminophen, butalbital, and caffeine

Generic name: Acetaminophen, Butalbital, And Caffeine
Drug class: Analgesic combinations

Usage of Acetaminophen, butalbital, and caffeine

Acetaminophen is a pain reliever and fever reducer.

Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache.

Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

Acetaminophen, butalbital, and caffeine is a combination medicine used to treat tension headaches that are caused by muscle contractions.

Acetaminophen, butalbital, and caffeine may also be used for purposes not listed in this medication guide.

Acetaminophen, butalbital, and caffeine side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking acetaminophen, butalbital, and caffeine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

This medicine may cause serious side effects. Stop using this medicine and call your doctor at once if you have:

confusion, a seizure;

shortness of breath;

a light-headed feeling, like you might pass out; or

nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of acetaminophen, butalbital, and caffeine may include:

drowsiness, dizziness;

feeling light-headed;

nausea, vomiting, stomach pain;

drunk feeling; or

shortness of breath.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Acetaminophen, butalbital, and caffeine

Do not use acetaminophen, butalbital, and caffeine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

You should not use acetaminophen, butalbital, and caffeine if you are allergic to it, if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other opioids.

Tell your doctor if you have ever had:

liver disease, cirrhosis, a history of alcoholism or drug addiction, or if you drink more than 3 alcoholic beverages per day;

kidney disease;

stomach ulcer or bleeding;

a history of skin rash caused by any medication; or

a history of mental illness or suicidal thoughts.

It is not known whether this medicine will harm an unborn baby. If you use butalbital while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

This medicine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breastfeeding a baby.

Not approved for use by anyone younger than 12 years old.

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How to use Acetaminophen, butalbital, and caffeine

Usual Adult Dose for Headache:

Butalbital 50 mg/acetaminophen 300 mg/caffeine 40 mg: 1 or 2 capsules orally every 4 hours as needed not to exceed 6 capsules per day Butalbital 50 mg/acetaminophen 325 mg/caffeine 40 mg: 1 or 2 capsules or tablets orally every 4 hours as needed not to exceed 6 capsules or tablets per day Butalbital 50 mg/acetaminophen 325 mg/caffeine per 15 mL oral liquid: 15 to 30 mL orally every 4 hours as needed not to exceed 90 mL per day Comments: -Due to high rate of physical dependence, the extended use of this drug is not recommended.-The safety and efficacy of treating multiple recurrent headaches with this product is not known. Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

Usual Pediatric Dose for Headache:

12 years or older:Butalbital 50 mg/acetaminophen 300 mg/caffeine 40 mg: 1 or 2 capsules orally every 4 hours as needed not to exceed 6 capsules per day Butalbital 50 mg/acetaminophen 325 mg/caffeine 40 mg: 1 or 2 capsules or tablets orally every 4 hours as needed not to exceed 6 capsules or tablets per day Butalbital 50 mg/acetaminophen 325 mg/caffeine per 15 mL oral liquid: 15 to 30 mL orally every 4 hours as needed not to exceed 90 mL per day Comments: -Due to high rate of physical dependence, the extended use of this drug is not recommended.-The safety and efficacy of treating multiple recurrent headaches with this product is not known. Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

Warnings

Do not use this medcine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

What other drugs will affect Acetaminophen, butalbital, and caffeine

Taking acetaminophen, butalbital, and caffeine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking acetaminophen, butalbital, and caffeine with a sleeping pill, opioid pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may affect acetaminophen, butalbital, and caffeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

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