Benzonatate: uses, appearance and warnings

Benzonatate capsules, USP are indicated for the symptomatic relief of cough.

Benzonatate Capsules USP, 100 mg are clear yellow, oval-shaped softgel capsules imprinted with “PC14” and are supplied as follows: NDC 42806-714-01 in bottle of 100 capsules NDC 42806-714-05 in bottle of 500 capsules Benzonatate Capsules USP, 200 mg are clear yellow, oval-shaped softgel capsules imprinted with “PC15” and are supplied as follows: NDC 42806-715-01 in bottle of 100 capsules NDC 42806-715-05 in bottle of 500 capsules Store at 20˚ to 25˚ C (68˚ to 77˚ F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT Dispense in tight (USP), child-resistant containers. Rx Only Distributed by: Epic Pharma, LLC Laurelton, NY 11413 Product of Taiwan. Rev. 06-2025-00 ZLN029

Hypersensitivity to benzonatate or related compounds.

Hypersensitivity Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures. Psychiatric Effects Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking Benzonatate capsules in combination with other prescribed drugs. Accidental Ingestion and Death in Children Keep benzonatate capsules out of reach of children. Accidental ingestion of benzonatate capsules resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE ).

Potential Adverse Reactions to benzonatate capsules may include: Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule. CNS sedation; headache; dizziness; mental confusion; visual hallucinations. GI constipation; nausea; GI upset. Dermatologic pruritus; skin eruptions. Other nasal congestion; sensation of burning in the eyes; vague “chilly” sensation; numbness of the chest; hypersensitivity. Deliberate or accidental overdose has resulted in death, particularly in children. Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.