benzonatate
Pharmaranks rates Benzonatate 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Benzonatate is a non-narcotic antitussive used to treat Cough, Hiccup.
Non-Narcotic Antitussive · by Bionpharma
Generic of Tessalon
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Benzonatate
- Drug class
- Non-Narcotic Antitussive
- Form
- Capsule
- Strength
- Benzonatate 100MG · Benzonatate 200MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Bionpharma
- What the pharmacy pays
- ~$2.16 for 30 — not your price
- FDA application
- ANDA081297
What is Benzonatate?
From the FDA label:Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p (butylamino) benzoate; with a molecular weight of 603.7. Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg benzonatate USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, glycerin, and purified water. Structural Formula
How to use
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 should be swallowed whole. BENZONATATE Capsules are not to be broken, chewed, dissolved, cut or crushed.
Side effects
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. To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma at 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Warnings
Important safety information
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 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).
Who should not take Benzonatate
Hypersensitivity to benzonatate or related compounds.
Overdose — what happens if you take too much
Intentional and unintentional overdose may result in death, particularly in children. The drug is chemically related to tetracaine and other topical anesthetics and shares various aspects of their pharmacology and toxicology. Drugs of this type are generally well absorbed after ingestion. Signs and Symptoms: The signs and symptoms of overdose of benzonatate have been reported within 15-20 minutes. If capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly, which may cause choking and airway compromise. CNS stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound CNS depression. Convulsions, coma, cerebral edema and cardiac arrest leading to death have been reported within 1 hour of ingestion. Treatment: In case of overdose, seek medical attention immediately. Evacuate gastric contents and administer copious amounts of activated charcoal slurry. Even in the conscious patient, cough and gag reflexes may be so depressed as to necessitate special attention to protection against aspiration of gastric contents and orally administered materials. Convulsions should be treated with a short-acting barbiturate given intravenously and carefully titrated for the smallest effective dosage. Intensive support of respiration and cardiovascular-renal function is an essential feature of the treatment of…
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Drug class
May treat (source: NIH RxClass)
Dosage forms
Capsule
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Benzonatate treat?
- Benzonatate (Benzonatate) may be used to treat cough, hiccup, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Benzonatate rated?
- pharmaranks gives Benzonatate a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Benzonatate cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $2.16 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Benzonatate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Benzonatate. To pay less, Benzonatate is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Benzonatate?
- Benzonatate is marketed by Bionpharma. You can see Bionpharma's full profile, rating, and other products on pharmaranks.
- Is Benzonatate a brand-name or generic drug?
- Benzonatate is a generic medication; its active ingredient is Benzonatate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Benzonatate available over the counter?
- No. Benzonatate is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Benzonatate come in?
- Benzonatate is currently marketed as capsule, per the FDA's National Drug Code Directory.
- What class of drug is Benzonatate?
- Benzonatate is classified as non-narcotic antitussive, per the FDA's Established Pharmacologic Class.
- Is Benzonatate FDA-registered?
- Benzonatate is on record with the U.S. FDA under application number ANDA081297. You can verify this on its official FDA label.
- Has Benzonatate been recalled by the FDA?
- Benzonatate has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Benzonatate safe?
- There's no single safe-or-not verdict. pharmaranks gives Benzonatate a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Benzonatate?
- Benzonatate's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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benzonatate
70/100