IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

BUTALBITAL W/ACETAMINOPHEN - ORAL

(byou-TAL-bih-tall WITH uh-seet-uh-MEE-no-fen)

COMMON BRAND NAME(S): Phrenilin

USES: This medication is a pain reliever and sedative. It is used to relieve tension headaches.

OTHER USES: This medication may also be used to treat pain when a calming effect is also needed.

HOW TO USE: To prevent upset stomach, take this medication with food or milk. Sustained-release preparations must be swallowed whole. Do not crush or chew them as this will destroy the long action and may increase side effects. Pain medications work best in preventing pain before it occurs. Once the pain becomes intense, the medication is not as effective in relieving it. This medication contains acetaminophen. Do not take more acetaminophen than recommended (see Side Effects section). Take this as prescribed. Do not increase your dose or take it more frequently without your doctor's approval.

SIDE EFFECTS: May cause lightheadedness, dizziness, drowsiness, stomach upset, nausea, and sleeping disturbances the first few days as your body adjusts to the medication. If these symptoms persist or become bothersome, inform your doctor. If you do not have liver problems, the adult maximum dose of acetaminophen is 4 grams per day (4000 milligrams). If you take more than the maximum daily amount, it may cause serious (possibly fatal) liver disease. Tell your doctor immediately if you have any of the following symptoms of liver damage: severe nausea, yellowing eyes or skin, dark urine, stomach pain, extreme fatigue. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Tell your doctor your medical history, especially of: liver disease, alcohol or narcotic dependence, emotional/mental problems, any allergies. To prevent oversedation, avoid using alcohol and other sedative type medications while taking this. This product contains acetaminophen. Acetaminophen may cause liver damage. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Check with your doctor or pharmacist for more information. This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages. Long-term use of this medication can lead to addiction. Do not take this more often or for longer than prescribed. Follow your doctor's instructions. This medication should be used during pregnancy only if clearly needed. Small amounts of this medication appear in breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription drugs you may use, especially of: "blood thinners" (e.g., warfarin). Tell your doctor or pharmacist of all prescription and nonprescription drugs you may use that cause drowsiness such as: medicine for sleep (e.g., sedatives), tranquilizers, anti-anxiety drugs (e.g., diazepam), narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine, or tricyclics such as amitriptyline), anti-seizure drugs (e.g., carbamazepine), muscle relaxants, antihistamines that cause drowsiness (e.g., diphenhydramine). Acetaminophen is an ingredient in many nonprescription products and in some combination prescription medications. Read the labels carefully before taking other pain relievers, fever reducers, or cold products to see if they also contain acetaminophen. Consult your pharmacist if you are uncertain if your other prescription or nonprescription products contain acetaminophen. (Also see adult maximum daily dose information in Side Effects section.) This drug may interfere with the effectiveness of birth control pills. Discuss using other methods of birth control with your doctor. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include vomiting, extreme drowsiness, lack of feeling alert, slow or shallow breathing, cold or clammy skin, loss of consciousness, severe nausea, yellowing eyes or skin, dark urine, stomach pain, extreme fatigue.

NOTES: Do not share this product with others.

MISSED DOSE: If you miss a dose, take it as soon as remembered; do not take if it is almost time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up.

STORAGE: Store at room temperature away from moisture and sunlight. Do not store in the bathroom.

Developed by First DataBank, Inc., San Bruno, CA
Copyright 2004 by First DataBank, Inc.