Benzonatate

Generic: BENZONATATE

Prescription DrugORAL

Drug Information

Brand Name
Benzonatate
Generic Name
BENZONATATE
Manufacturer
Bryant Ranch Prepack
Product Type
Prescription Drug
Route
ORAL
Application Number
0f91fd98-1a86-42aa-8055-d339bff73015

Pharmacological Class

Non-narcotic Antitussive [EPC]

Indications & Usage

INDICATIONS AND USAGE Benzonatate capsules is indicated for the symptomatic relief of cough.

Warnings

WARNINGS 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 ta...

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WARNINGS 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).

Adverse Reactions

ADVERSE REACTIONS 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. Der m atologic: pruritus; skin eruptions. Other: nasal congestion; sensation of burning in the eyes; vague โ€œchillyโ€ sensation; numbness of th...

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ADVERSE REACTIONS 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. Der m atologic: pruritus; skin eruptions. Other: nasal congestion; sensation of burning in the eyes; vague โ€œchillyโ€ sensation; numbness of the chest; hypersensitivity. Deliberate or accidental overdose has resulted in death, particularly in children.

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare provider before making any decisions about your medications. Data sourced from openFDA.

Benzonatate - Side Effects, Warnings, Uses | FDA Drug Database