Benzonatate
Generic: BENZONATATE
Basic Information
Manufacturer
RedPharm Drug, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
a2f6acff-70ff-79f1-e053-2a95a90a6005
Indications & Usage
INDICATIONS AND USAGE Benzonatate capsules, USP are 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 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 ).
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.
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.
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.