Benzonatate 100 mg
Drug Details
- Generic Name
- Benzonatate 100 mg
- Brand Names
- Benzonatate 100 mg
- Application Number
- ANDA220298
- Sponsor
- MARKSANS PHARMA LIMITED
- NDC Codes
- 1
- Dosage Forms
- CAPSULE, LIQUID FILLED
- Routes
- ORAL
- Active Ingredients
- BENZONATATE
Indications and Usage
INDICATIONS & USAGE Benzonatate capsules 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 in combination with other prescribed drugs. Accidental Ingestion and Death in Children Keep benzonatate capsules out of reach of children. Accidental ingestion of benzonatate 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)