Life-threatening and fatal events in infants and young children; Post-marketing cases of seizures, cardiopulmonary arrest, and death in patients under the age of 3 years have been reported with use of Lidocaine 2% Viscous Solution when it was not administered in strict adherence to the dosing and administration recommendations. In the setting of teething pain, Chalocaine Viscous Solution should generally not be used. For other conditions, the use of the product in patients less than 3 years of age should be limited to those situations where safer alternatives are not available or have been tried but failed.
To decrease the risk of serious adverse events with use of Chalocaine Viscous Solution, instruct caregivers to strictly adhere to the prescribed dose and frequency of administration and store the prescription bottle safely out of reach of children.
Not approved for relief of teething pain and discomfort in infants and children; serious adverse (toxic) effects have been reported.
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