"The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restricting the use of codeine for cough and cold in children because there is a risk for serious adverse effects, including respiratory"...
Swallow TESSALON (benzonatate) Capsules and Perles whole. Do not break, chew, dissolve, cut, or crush TESSALON (benzonatate) Capsules and Perles. Release of TESSALON (benzonatate) from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of food or liquids until the numbness has resolved. If the symptoms worsen or persist, seek medical attention.
Keep TESSALON (benzonatate) out of reach of children. Accidental ingestion resulting in death has been reported in children. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. Signs and symptoms may include restlessness, tremors, convulsions, coma and cardiac arrest. If accidental ingestion occurs, seek medical attention immediately.
Overdosage resulting in death may occur in adults.
Do not exceed a single dose of 200 mg and a total daily dosage of 600 mg. If you miss a dose of TESSALON (benzonatate), skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of TESSALON (benzonatate) at one time.
Prescribing Document Revised: January 2011This monograph has been modified to include the generic and brand name in many instances.
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