Benzonatate 100 mg 100 mg/1
Benzonatate 100 mg · CAPSULE, LIQUID FILLED · MARKSANS PHARMA LIMITED
Benzonatate 100 mg is a capsule, liquid filled containing benzonatate 100 mg at 100 mg/1, taken oral. Manufactured by MARKSANS PHARMA LIMITED.
Key Facts
- Brand Name
- Benzonatate 100 mg
- Generic Name
- Benzonatate 100 mg
- NDC Code (Product)
25000-002- Manufacturer
- MARKSANS PHARMA LIMITED
- Strength
- 100 mg/1
- Dosage Form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA220298
- Drug Class
- Non-narcotic Antitussive [EPC]
- Marketing Start
- 04/10/2026
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS & USAGE Benzonatate capsules are indicated for the symptomatic relief of cough.
Dosage & Administration
DOSAGE & ADMINISTRATION Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate Capsules should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.
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)
Contraindications
CONTRAINDICATIONS Hypersensitivity to benzonatate or related compounds.
Adverse Reactions
ADVERSE REACTIONS Potential Adverse Reactions to benzonatate 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.
Frequently Asked Questions
What is Benzonatate 100 mg used for?
Benzonatate 100 mg contains Benzonatate 100 mg. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.
Is Benzonatate 100 mg a controlled substance?
Benzonatate 100 mg is not classified as a controlled substance by the DEA.
What is the generic name for Benzonatate 100 mg?
The generic name for Benzonatate 100 mg is Benzonatate 100 mg. There are no other listed brand versions of Benzonatate 100 mg.
What is the NDC code for Benzonatate 100 mg 100 mg/1?
The NDC (National Drug Code) for Benzonatate 100 mg 100 mg/1 is 25000-002, listed by MARKSANS PHARMA LIMITED.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)