Aspirin is in a class of drugs called salicylates. Aspirin works reducing substances in the body that cause pain and inflammation. It is used to reduce pain, inflammation, and fever.

Caffeine is used in this combination to increase the pain relieving effects of aspirin and orphenadrine.

Orphenadrine is a muscle relaxant. It works by blocking nerve impulses (or pain sensations) that are sent to the brain.

Norgesic (aspirin/caffeine/orphenadrine) is used, along with rest and physical therapy, to treat injuries and other painful muscular conditions.

This medicine may also be used for purposes other than those listed in this medication guide.

Use caution when driving, operating machinery, or performing other hazardous activities. Norgesic may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking Norgesic. Also, in combination with aspirin, alcohol can be damaging to the stomach.

Call your doctor immediately if you experience a rash, itching, a fever, or nasal congestion during treatment with this medicine.

Watch for bloody, black, or tarry stools or bloody vomit. This could indicate damage to the stomach.

Do not take more of this medication than is prescribed. If the pain is not being adequately treated, talk to your doctor.

Who should not take Norgesic?

Before taking this medication, tell your doctor if you have

• kidney disease,

• liver disease,

• a stomach or intestinal ulcer or obstruction,

• a bleeding or blood clotting disorder,

• glaucoma,

• an enlarged prostate or a blockage of the urinary tract (difficulty urinating), or

• myasthenia gravis.

You may not be able to take Norgesic, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether this medicine will be harmful to an unborn baby. Do not take Norgesic without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether Norgesic passes into breast milk. Do not take this medicine without first talking to your doctor if you are breast-feeding a baby.

Norgesic is not approved for use by children younger than 12 years of age. Do not use any medication that contains aspirin to treat a child or teenager who has a fever, flu symptoms, or chicken pox without first talking to a doctor. In children younger than 20 years of age, aspirin may increase the risk of Reye's syndrome, a rare but often fatal condition.

Take Norgesic exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Do not take more of this medication than is prescribed. If the pain is not being adequately treated, talk to your doctor.

Store Norgesic at room temperature away from moisture and heat.

Before taking this medication, tell your doctor if you have

• kidney disease,

• liver disease,

• a stomach or intestinal ulcer or obstruction,

• a bleeding or blood clotting disorder,

• glaucoma,

• an enlarged prostate or a blockage of the urinary tract (difficulty urinating), or

• myasthenia gravis.

You may not be able to take Norgesic, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether this medicine will be harmful to an unborn baby. Do not take Norgesic without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether Norgesic passes into breast milk. Do not take this medicine without first talking to your doctor if you are breast-feeding a baby.

Norgesic is not approved for use by children younger than 12 years of age. Do not use any medication that contains aspirin to treat a child or teenager who has a fever, flu symptoms, or chicken pox without first talking to a doctor. In children younger than 20 years of age, aspirin may increase the risk of Reye's syndrome, a rare but often fatal condition.

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

Seek emergency medical attention.

Symptoms of an Norgesic (aspirin/caffeine/orphenadrine) overdose include headache; ringing in the ears; nausea; vomiting; diarrhea; dry mouth; weakness; confusion; decreased breathing; seizures; cold, clammy skin; and unconsciousness.

Use caution when driving, operating machinery, or performing other hazardous activities. Norgesic may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking Norgesic. Also, in combination with aspirin, alcohol can be damaging to the stomach.

Do not take other over-the-counter and prescription products that contain aspirin. Too much aspirin could be dangerous. Talk to your doctor or pharmacist before taking any over-the-counter preparations.

If you experience any of the following serious side effects, stop taking Norgesic and seek emergency medical attention or contact your doctor immediately:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• an irregular or a very fast heartbeat;

• confusion, hallucinations, or abnormal behavior;

• red, black, or bloody stools; or

• blood in vomit.

Other, less serious side effects may be more likely to occur. Continue to take Norgesic and talk to your doctor if you experience

• drowsiness or dizziness;

• headache;

• tremor;

• blurred vision or large pupils;

• difficulty urinating;

• hiccups;

• faint ringing in the ears; or

• nausea, vomiting, or constipation.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Drowsiness or dizziness caused by orphenadrine may be increased by other drugs such as antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), other pain relievers, anxiety medicines, and muscle relaxants. Together, these medicines may cause dangerous sedation, possibly resulting in unconsciousness and death. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor.

Do not take Norgesic without first talking to your doctor if you are taking any of the following medicines:

• an anticoagulant such as warfarin (Coumadin), heparin, enoxaparin (Lovenox), dalteparin (Fragmin), danaparoid (Orgaran), ardeparin (Normiflo), or tinzaparin (Innohep);

• a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil, Nuprin, others), ketoprofen (Orudis, Orudis KT, Oruvail), naproxen (Naprosyn, Anaprox, Aleve), diclofenac (Voltaren, Cataflam), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), sulindac (Clinoril), or tolmetin (Tolectin); or

• another salicylate such as aspirin (Acuprin, Ecotrin, Ascriptin, Bayer, others); choline salicylate and/or magnesium salicylate (Magan, Doan's, Bayer Select Backache Pain Formula, Mobidin, Arthropan, Trilisate, Tricosal), or salsalate (Disalcid).

You may not be able to take Norgesic, or you may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with Norgesic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.