Label Changes for:

Tessalon (benzonatate) Perles and Capsules

January 2011

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

 

WARNINGS

Accidental Ingestion and Death in Children
  • Keep Tessalon out of reach of children. Accidental ingestion......seek medical attention immediately (see OVERDOSAGE)

PRECAUTIONS

Information for Patients
  • Swallow Tessalon capsules and perles whole......Do not take 2 doses of Tessalon at one time.
Pediatric Use
  • Accidental ingestion...below age 10. Keep out of reach of children.

ADVERSE REACTIONS

Other
  • Deliberate or accidental overdose  has resulted in death, particularly in children. 
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