Medications and Drugs

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Brand Names: Bupap, Cephadyn, Marten-Tab, Phrenilin, Phrenilin Forte, Promacet, Sedapap

Generic Name: acetaminophen and butalbital (Pronunciation: a SEET a MIN oh fen and bue TAL bi tal)

• What is acetaminophen and butalbital (Bupap, Cephadyn, Marten-Tab, Phrenilin, Phrenilin Forte, Promacet, Sedapap)?
• What are the possible side effects of acetaminophen and butalbital?
• What is the most important information I should know about acetaminophen and butalbital?
• What should I discuss with my healthcare provider before taking acetaminophen and butalbital?
• How should I take acetaminophen and butalbital?
• What happens if I miss a dose?
• What happens if I overdose?
• What should I avoid while taking acetaminophen and butalbital?
• What other drugs will affect acetaminophen and butalbital?
• Where can I get more information?

What is acetaminophen and butalbital (Bupap, Cephadyn, Marten-Tab, Phrenilin, Phrenilin Forte, Promacet, Sedapap)?

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.

The combination of acetaminophen and butalbital is used to treat tension headaches. This medicine is not for treating headaches that come and go.

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

Axocet

white, imprinted with LOGO, 0198

Cephadyn

oblong, blue, imprinted with 110, AP

Phrenilin Forte

purple, imprinted with C, 8656

Phrenilin Forte-VAL

lavender, imprinted with VALEANT, PF 0844

Phrenilin-VAL

round, lavender, imprinted with 50, A

Promacet 650mg-50 mg

oblong, green, imprinted with PROMACET, MCR 524

Sedapap 650 mg-50 mg

oblong, imprinted with MP 392

What are the possible side effects of acetaminophen and butalbital?

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

Call your doctor at once if you have a serious side effect such as:

• fast or pounding heart rate, feeling short of breath;
• feeling like you might pass out;
• confusion, depression;
• feeling restless, excited, or agitated;
• seizure (convulsions); or
• nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects include:

• headache, dizziness, drowsiness, shaky feeling;
• drunk feeling;
• vomiting, constipation;
• heartburn, trouble swallowing;
• numbness or tingly feeling;
• dry mouth;
• sweating or urinating more than usual;
• leg pain, tired muscles;
• stuffy nose, ear pain, ringing in your ears; or
• mild itching.

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.

What is the most important information I should know about acetaminophen and butalbital?

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen.

Before you take acetaminophen and butalbital, tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease, a stomach or intestinal disorder, or a history of drug or alcohol addiction.

Butalbital may be habit-forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

Tell your doctor if the medicine seems to stop working as well in relieving your pain.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

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