Narcotic Analgesics and Acetaminophen (Systemic)

Precautions While Using This Medicine

If you will be taking this medicine for a long time (for example, for several months at a time), or in high doses, your doctor should check your progress at regular visits.

Check the labels of all nonprescription (over-the-counter [OTC]) and prescription medicines you now take . If any contain acetaminophen or a narcotic be especially careful, since taking them while taking this medicine may lead to overdose. If you have any questions about this, check with your medical doctor, dentist, or pharmacist.

The narcotic analgesic in this medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your medical doctor or dentist before taking any of the medicines listed above, while you are using this medicine .

Too much use of the acetaminophen in this combination medicine together with certain other medicines may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. If your doctor directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take this medicine together with any of the following medicines for more than a few days, unless your doctor has directed you to do so and is following your progress:

• Aspirin or other salicylates
• Diclofenac (e.g., Voltaren)
• Diflunisal (e.g., Dolobid)
• Etodolac (e.g., Lodine)
• Fenoprofen (e.g., Nalfon)
• Floctafenine (e.g., Idarac)
• Flurbiprofen, oral (e.g., Ansaid)
• Ibuprofen (e.g., Motrin)
• Indomethacin (e.g., Indocin)
• Ketoprofen (e.g., Orudis)
• Ketorolac (e.g., Toradol)
• Meclofenamate (e.g., Meclomen)
• Mefenamic acid (e.g., Ponstel)
• Nabumetone (e.g., Relafen)
• Naproxen (e.g., Naprosyn)
• Oxaprozin (e.g., Daypro)
• Phenylbutazone (e.g., Butazolidin)
• Piroxicam (e.g., Feldene)
• Sulindac (e.g., Clinoril)
• Tenoxicam (e.g., Mobiflex)
• Tiaprofenic acid (e.g., Surgam)
• Tolmetin (e.g., Tolectin)

This medicine may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded .

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.

Nausea or vomiting may occur, especially after the first couple of doses. This effect may go away if you lie down for a while. However, if nausea or vomiting continues, check with your medical doctor or dentist. Lying down for a while may also help relieve some other side effects, such as dizziness or lightheadedness, that may occur.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Narcotic analgesics may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

If you have been taking this medicine regularly for several weeks or more, do not suddenly stop taking it without first checking with your doctor . Your doctor may want you to reduce gradually the amount you are taking before stopping completely, to lessen the chance of withdrawal side effects. This will depend on which of these medicines you have been taking, and the amount you have been taking every day.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once . Taking an overdose of this medicine or taking alcohol or CNS depressants with this medicine may lead to unconsciousness or death. Signs of overdose of narcotics include convulsions (seizures), confusion, severe nervousness or restlessness, severe dizziness, severe drowsiness, shortness of breath or troubled breathing, and severe weakness. Signs of severe acetaminophen overdose may not occur until several days after the overdose is taken.