Label Changes for:
Tessalon (benzonatate) Perles and Capsules
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2011
Accidental Ingestion and Death in Children
- Keep Tessalon out of reach of children. Accidental ingestion......seek medical attention immediately (see OVERDOSAGE)
Information for Patients
- Swallow Tessalon capsules and perles whole......Do not take 2 doses of Tessalon at one time.
- Accidental ingestion...below age 10. Keep out of reach of children.
- Deliberate or accidental overdose has resulted in death, particularly in children.