What is the recommended age group for using Tessalon (benzonatate) as a cough suppressant?

Tessalon (Benzonatate) Age Recommendations

Tessalon (benzonatate) is FDA-approved only for children over 10 years of age and adults, and should never be used in children under 10 due to documented fatal overdoses in this age group. 1

FDA-Approved Age Range

• Approved for children over 10 years of age and adults at a usual dose of one 100 mg or 200 mg capsule three times daily as needed for cough 1
• Maximum daily dose is 600 mg in three divided doses 1
• Safety and effectiveness in children below age 10 have NOT been established 1

Critical Safety Concerns in Young Children

Accidental ingestion in children under 10 years old has resulted in death, with fatal outcomes occurring within 15-20 minutes to one hour of ingestion 1, 2:

• Five fatalities occurred in children 2 years of age and younger from accidental ingestions 2
• Emergency department data captured 12 overdose cases from accidental ingestions in children aged 1-3 years 2
• Signs of overdose include seizures, cardiac arrest, coma, brain edema, apnea, and respiratory arrest—often within 15 minutes 1, 2

Pediatric Exposure Trends

Recent surveillance data (2010-2018) reveals concerning patterns 3:

• Among 4,689 pediatric benzonatate exposure cases, 77% were unintentional exposures 3
• 83% of unintentional exposures involved children 0-5 years old 3
• Rising patterns of both unintentional ingestion in young children and intentional ingestion in adolescents 10-16 years old 3

Clinical Context for Cough Management

Benzonatate should not be first-line therapy even in approved age groups, as current pediatric cough guidelines emphasize treating underlying causes rather than symptomatic suppression 4, 5:

• Over-the-counter cough medications (including antitussives) are not recommended for children under 6 years due to lack of efficacy and safety concerns 4, 5
• For chronic cough in children ≤14 years, treatment should target the underlying etiology rather than using empiric antitussive therapy 4, 5

Essential Safety Warnings

Capsules must be swallowed whole—never broken, chewed, dissolved, cut, or crushed 1:

• Release of benzonatate in the mouth produces temporary local anesthesia of oral mucosa and can cause choking 1
• If numbness or tingling of tongue, mouth, throat, or face occurs, refrain from oral intake until numbness resolves 1

Keep out of reach of children at all times 1, 3