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Norflex Warnings, Precautions, Pregnancy, Nursing, Abuse - Orphenadrine Citrate, Aspirin and Caffeine (tablets)

Norflex Warnings, Precautions, Pregnancy, Nursing, Abuse - Orphenadrine Citrate, Aspirin and Caffeine (tablets)

WARNINGS

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. Orphenadrine Citrate, Aspirin and Caffeine 25 mg/385 mg/30 mg and Orphenadrine Citrate, Aspirin and Caffeine 50 mg/770 mg/60 mg Tablets contain aspirin and therefore are not recommended for use in patients with chicken pox, influenza, or flu symptoms.

Orphenadrine Citrate, Aspirin and Caffeine 25 mg/385 mg/30 mg and Orphenadrine Citrate, Aspirin and Caffeine 50 mg/770 mg/60 mg Tablets 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.

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

Usage in Children: The safe and effective use of this drug in children has not been established. Usage of this drug in children under 12 years of age is not recommended.

PRECAUTIONS

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 Orphenadrine Citrate, Aspirin and Caffeine 25 mg/385 mg/30 mg and Orphenadrine Citrate, Aspirin and Caffeine 50 mg/770 mg/60 mg Tablets has not been established; therefore, if Orphenadrine Citrate, Aspirin and Caffeine 25 mg/385 mg/30 mg or Orphenadrine Citrate, Aspirin and Caffeine 50 mg/770 mg/60 mg Tablets is prescribed for prolonged use, periodic monitoring of blood, urine and liver function values is recommended.

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