What is the approved age range for benzonatate?

Approved Age Range for Benzonatate

Benzonatate is FDA-approved for use in adults and children 10 years of age and older. 1

FDA-Approved Age Indication

• Minimum age: 10 years and older 1
• Safety and effectiveness in children below the age of 10 have not been established 1
• The FDA drug label explicitly states that benzonatate should not be used in children under 10 years of age 1

Critical Safety Considerations

Accidental ingestion in young children can be fatal, with death reported within one hour of ingestion. 1

• Fatal overdoses have been documented in children under 10 years old, particularly in those aged 2 years and younger 2
• Signs and symptoms of overdose can appear within 15-20 minutes and include restlessness, tremors, convulsions, coma, and cardiac arrest 1
• The majority of unintentional exposures (83%) occur in children 0-5 years old 3

Dosing for Approved Age Group

For adults and children over 10 years of age: 1

• Usual dose: 100 mg or 200 mg capsule three times daily as needed for cough 1
• Maximum daily dose: 600 mg in three divided doses 1
• Capsules must be swallowed whole—they should not be broken, chewed, dissolved, cut, or crushed 1

Storage and Handling Warning

Benzonatate must be kept out of reach of children at all times. 1

• Release of benzonatate from the capsule in the mouth can produce temporary local anesthesia of the oral mucosa and choking 1
• If numbness or tingling of the tongue, mouth, throat, or face occurs, patients should refrain from oral ingestion until numbness resolves 1