Reye's Syndrome may develop in individuals who have chicken pox, influenza, or flu symptoms. Some studies suggest a possible association between the development of Reye's Syndrome and the use of medicines containing salicylate or aspirin. Norgesic and Norgesic Forte contain aspirin and therefore are not recommended for use in patients with chicken pox, influenza, or flu symptoms.

Norgesic and Norgesic Forte may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients should therefore be cautioned accordingly.

Aspirin should be used with extreme caution in the presence of peptic ulcers and coagulation abnormalities.

Children- Do not give a medicine containing aspirin to a child or a teenager with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child's doctor. This is very important because aspirin may cause a serious illness called Reye's syndrome in children with fever caused by a virus infection, especially flu or chickenpox. Children who do not have a virus infection may also be more sensitive to the effects of aspirin, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating. This may increase the chance of side effects during treatment.

There is no specific information about the use of orphenadrine in children.

Confusion, anxiety and tremors have been reported in a few patients receiving propoxyphene and orphenadrine concomitantly. As these symptoms may be simply due to an additive effect, reduction of dosage and/or discontinuation of one or both agents is recommended in such cases.

Safety of continuous long term therapy with Norgesic and Norgesic Forte has not been established; therefore, if Norgesic or Norgesic Forte is prescribed for prolonged use, periodic monitoring of blood, urine and liver function values is recommended.

For diabetic patients:

• The aspirin in this combination medicine may cause false urine sugar test results if you are regularly taking 6 or more of the regular-strength tablets or 3 or more of the double-strength tablets of this medicine a day. Smaller doses or occasional use of aspirin usually will not affect urine sugar tests. If you have any questions about this, check with your health care professional especially if your diabetes is not well controlled.

Do not take this medicine for 5 days before any surgery, including dental surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems.

Usage in Pregnancy

Since safety of the use of this preparation in pregnancy, during lactation, or in the childbearing age has not been established, use of the drug in such patients requires that the potential benefits of the drug be weighed against its possible hazard to the mother and child.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

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