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.

NARCOTIC ANALGESIC/APAP/CAFFEINE/BUTALBITAL - ORAL

Uses

This combination medication contains a narcotic pain reliever, acetaminophen (a non-aspirin pain reliever), caffeine and butalbital. Caffeine is used to enhance pain relief, especially in certain types of headaches. Butalbital provides a calming effect. This combination medication is used to relieve moderate to severe pain.

How To Use

Take this by mouth with food or milk if stomach upset occurs. Take this medication exactly as prescribed. Do not increase the dose, take it more often than directed or continue taking this for longer than prescribed. This medication contains acetaminophen. Do not take more acetaminophen than recommended (see Side Effects section).

Side Effects

Stomach upset, headache, blurred vision, constipation, drowsiness, dizziness or lightheadedness may occur. If any of these effects persist or worsen, inform your doctor. Notify your doctor immediately if you develop: rapid heart rate, fainting, breathing difficulties, mood changes, depression, irritability, nervousness. 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 if you have a history of: asthma or other breathing disorders, kidney disease, liver disease, drug dependency, allergies (especially drug allergies). Use caution performing tasks requiring alertness if this medication causes you to feel drowsy or dizzy. 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. To avoid dizziness and lightheadedness when rising from a seated or lying position, get up slowly. Also limit your intake of alcoholic beverages which will aggravate these effects. The elderly and children may be more susceptible to the effects of this medication. Use this with caution. This medication should be used during pregnancy only if clearly needed. Discuss the risks and benefits with your doctor. It is not known if this medication appears in breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Tell your doctor of any over-the-counter or prescription medication you may take including: medication for depression or seizures, other narcotic pain relievers, sleeping pills, sedatives, cimetidine, quinidine. This drug may interfere with the effectiveness of birth control pills. Discuss using other methods of birth control with your doctor. 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). Avoid the use of alcohol while taking this medication. 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, excessive drowsiness or dizziness, slow or shallow breathing, cold or clammy skin, rapid or irregular heartbeat, seizures, loss of consciousness, severe nausea, yellowing eyes or skin, dark urine, stomach pain, extreme fatigue.

Notes

Long-term or excessive use of narcotic analgesics may lead to dependency. It is important that you follow your dosing schedule as prescribed. If the dose prescribed does not provide pain relief, contact your doctor.

Missed Dose

If you miss a dose, take it as soon as remembered; do not take it if it is near the 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 between 59 and 86 degrees F (15 and 30 degrees C) away from heat and light. Do not store in the bathroom.