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benzonatate 100 mg Capsule, 100-count — NDC 71335-1329-03 package photo

benzonatate 100 mg Capsule, 100-count

by Bryant Ranch Prepack · 100 CAPSULE in 1 BOTTLE (71335-1329-3)
NDC 71335-1329-03
🏷️ FDA NDC (as labeled) 71335-1329-3 billing pads the package segment with a zero
This package
Contains100-count Pack sizes10 compare ↓
Also comes in: 10 capsules 71335-1329-00 14 capsules 71335-1329-08 15 capsules 71335-1329-04 20 capsules 71335-1329-02 30 capsules 71335-1329-01 40 capsules 71335-1329-09 60 capsules 71335-1329-06 90 capsules 71335-1329-07 120 capsules 71335-1329-05
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Benzonatate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Dec 26, 2023 — Superpotent drug: Assay results were slightly above specification at the time zero point. (Amerisource Health Services LLC) · FDA recall D-0257-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 71335-1329-3
Product NDC 71335-1329
11-digit billing NDC 71335132903
RxCUI 197397
UNII 5P4DHS6ENR
Application # ANDA040627
SPL Set ID 143a5ba8-0ee9-43be-a0da-2c455c1a46bd
Established class (EPC) Non-narcotic Antitussive
Physiologic effect Decreased Tracheobronchial Stretch Receptor Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-03-22
Route ORAL
Dosage form CAPSULE
Substance BENZONATATE
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 71335-1329-3 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 71335-1329-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Non-narcotic Antitussive class.

Pharmacologic class Non-narcotic Antitussive
Drug family (ATC) Other cough suppressants
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerBryant Ranch Prepack
Application holderTHEPHARMANETWORK LLC
FDA applicationANDA040627 (ANDA)
Labeler code71335
First marketedMar 2017
Product typeHuman Prescription Drug
Portfolio4,431 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Benzonatate is used to relieve cough. Benzonatate is in a class of medications called antitussives (cough suppressants). It works by reducing the cough reflex in the lungs and air passages.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It works by numbing tiny nerve sensors in your airways and lungs that trigger the urge to cough. Think of it like a local anesthetic for your respiratory system — it quiets those s...
  • What is benzonatate actually doing to stop my cough?
  • This is genuinely one of the most important rules with benzonatate. If you chew, crush, or suck on the capsule, the medication gets released directly in your mouth and throat. It t...
  • Why does my pharmacist keep saying I must swallow it whole?
📖 Read our full Benzonatate guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color yellow
ShapeCapsule
Imprint105
Size19 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 capsules 14 capsules 15 capsules 20 capsules 30 capsules 40 capsules 60 capsules 90 capsules 120 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Benzonatate 100 mg 00904-6564-60 Major 100 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 00904-7153-61 Major 100 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 23155-0898-01 Heritage 100 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 31722-0956-01 Camber 100 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 42806-0714-01 Epic 100 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 62135-0440-31 Chartwell 300 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 64380-0712-06 Strides 100 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 64980-0634-01 Rising 100 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 67877-0573-01 Ascend 100 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 68084-0214-01 American 100 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 68382-0247-01 Zydus 100 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 69452-0143-20 Bionpharma 100 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 51224-0010-50 TAGI 100 capsules $0.083 AA FDA listed —
Benzonatate 100 mg 00615-8403-39 NCS 30 capsules — AA FDA listed —
Benzonatate 100 mg 25000-0002-03 MARKSANS 30 capsules — AA FDA listed —
Benzonatate 100 mg 42291-0091-01 AvKARE 100 capsules — AA FDA listed —
Benzonatate 100 mg 50090-4968-00 A-S 15 capsules — AA FDA listed —
Benzonatate 100 mg 50090-4969-00 A-S 20 capsules — AA FDA listed —
Benzonatate 100 mg 50090-5409-00 A-S 20 capsules — AA FDA listed —
Benzonatate 100 mg 50090-5986-00 A-S 15 capsules — AA FDA listed —
Benzonatate 100 mg 50090-6387-00 A-S 20 capsules — AA FDA listed —
Benzonatate 100 mg 50090-6850-00 A-S 15 capsules — AA FDA listed —
Benzonatate 100 mg 51655-0754-20 Northwind 20 capsules — AA FDA listed —
Benzonatate 100 mg 55154-3372-00 Cardinal 10 capsules — AA FDA listed —
Benzonatate 100 mg 60429-0927-01 Golden 100 capsules — AA FDA listed —
Benzonatate 100 mg 60760-0700-30 St. 30 capsules — AA FDA listed —
Benzonatate 100 mg 60760-0869-15 St. 15 capsules — AA FDA listed —
Benzonatate 100 mg 61919-0400-20 DIRECT 20 capsules — AA FDA listed —
Benzonatate 100 mg 63187-0076-14 Proficient 14 capsules — AA FDA listed —
Benzonatate 100 mg 63187-0799-14 Proficient 14 capsules — AA FDA listed —
benzonatate 100 mg 63187-0928-10 Proficient 10 capsules — AA FDA listed —
Benzonatate 100 mg 63629-2473-01 Bryant 500 capsules — AA FDA listed —
Benzonatate 100 mg 63629-2474-01 Bryant 100 capsules — AA FDA listed —
Benzonatate 100 mg 63629-9189-01 Bryant 500 capsules — AA FDA listed —
Benzonatate 100 mg 65162-0536-10 Amneal 100 capsules — AA FDA listed —
Benzonatate 100 mg 65841-0614-01 Zydus 100 capsules — AA FDA listed —
Benzonatate 100 mg 67046-1484-03 Coupler 30 capsules — AA FDA listed —
Benzonatate 100 mg 67046-1629-03 Coupler 30 capsules — AA FDA listed —
Benzonatate 100 mg 67296-2194-01 Redpharm 15 capsules — AA FDA listed —
Benzonatate 100 mg 67296-2207-01 Redpharm 15 capsules — AA FDA listed —
Benzonatate 100 mg 68071-5083-03 NuCare 30 capsules — AA FDA listed —
Benzonatate 100 mg 68071-5105-04 NuCare 4 capsules — AA FDA listed —
Benzonatate 100 mg 68071-5156-02 NuCare 20 capsules — AA FDA listed —
Benzonatate 100 mg 68071-5223-04 NuCare 4 capsules — AA FDA listed —
Benzonatate 100 mg 68094-0798-50 Precision 100 capsules — AA FDA listed —
Benzonatate 100 mg 68788-7607-00 Preferred 9 capsules — AA FDA listed —
Benzonatate 100 mg 70518-2873-00 REMEDYREPACK 10 capsules — AA FDA listed —
Benzonatate 100 mg 70518-4558-00 REMEDYREPACK 30 capsules — AA FDA listed —
Benzonatate 100 mg 71205-0067-10 Proficient 10 capsules — AA FDA listed —
Benzonatate 100 mg 71205-0632-10 Proficient 10 capsules — AA FDA listed —
Benzonatate 100 mg 71205-0699-10 Proficient 10 capsules — AA FDA listed —
Benzonatate 100 mg 71205-0853-00 Proficient 100 capsules — AA FDA listed —
benzonatate 100 mg 71205-0971-00 Proficient 100 capsules — AA FDA listed —
Benzonatate 100 mg 71335-0091-00 Bryant 10 capsules — AA FDA listed —
benzonatate 100 mg 71335-0688-00 Bryant 10 capsules — AA FDA listed —
benzonatate 100 mgthis 71335-1329-03 Bryant 100 capsules — AA FDA listed —
Benzonatate 100 mg 71335-1544-00 Bryant 10 capsules — AA FDA listed —
Benzonatate 100 mg 71335-1927-00 Bryant 10 capsules — AA FDA listed —
Benzonatate 100 mg 71335-1968-00 Bryant 10 capsules — AA FDA listed —
Benzonatate 100 mg 71335-2672-01 Bryant 500 capsules — AA FDA listed —
Benzonatate 100 mg 71335-3068-00 Bryant 10 capsules — AA FDA listed —
Benzonatate 100 mg 71610-0692-30 Aphena 30 capsules — AA FDA listed —
Benzonatate 100 mg 72162-1561-01 Bryant 100 capsules — AA FDA listed —
Benzonatate 100 mg 72189-0194-20 DIRECT 20 capsules — AA FDA listed —
Benzonatate 100 mg 72789-0230-06 PD-Rx 6 capsules — AA FDA listed —
Benzonatate 100 mg 72789-0231-15 PD-Rx 15 capsules — AA FDA listed —
Benzonatate 100 mg 72865-0117-01 XLCare 100 capsules — AA FDA listed —
Benzonatate 100 mg 76420-0803-01 Asclemed 100 capsules — AA FDA listed —
Benzonatate 100 mg 85766-0066-01 Sportpharm 100 capsules — AA FDA listed —
Benzonatate 100 mg 85766-0089-01 Sportpharm 100 capsules — AA FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2017
On the market since
Mar 2017
📍
2026
Currently FDA-listed
9 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Benzonatate — the program that covers self-administered drugs. 12 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Benzonatate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$654.6K
Claims incl. refills
49.4K
Beneficiaries
42.4K
Spend / beneficiary
$15.42
Spend / claim
$13.25
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71335-1329-00 10 CAPSULE in 1 BOTTLE (71335-1329-0) 2017-03-22 Active
71335-1329-01 30 CAPSULE in 1 BOTTLE (71335-1329-1) 2017-03-22 Active
71335-1329-02 20 CAPSULE in 1 BOTTLE (71335-1329-2) 2017-03-22 Active
71335-1329-03 You're viewing this 100 CAPSULE in 1 BOTTLE (71335-1329-3) 2017-03-22 Active
71335-1329-04 15 CAPSULE in 1 BOTTLE (71335-1329-4) 2017-03-22 Active
71335-1329-05 120 CAPSULE in 1 BOTTLE (71335-1329-5) 2017-03-22 Active
71335-1329-06 60 CAPSULE in 1 BOTTLE (71335-1329-6) 2017-03-22 Active
71335-1329-07 90 CAPSULE in 1 BOTTLE (71335-1329-7) 2017-03-22 Active
71335-1329-08 14 CAPSULE in 1 BOTTLE (71335-1329-8) 2017-03-22 Active
71335-1329-09 40 CAPSULE in 1 BOTTLE (71335-1329-9) 2017-03-22 Active

You're viewing one of 10 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71335-1329-03?
NDC 71335-1329-03 is a 100-count package — 100 capsule in 1 bottle.
What is the difference between NDC 71335-1329-03 and NDC 71335-1329-00?
Both are benzonatate 100 mg Capsule — the drug itself is identical. NDC 71335-1329-03 is the 100-count package, while NDC 71335-1329-00 is the 10 capsules package.
What NDC number is used to bill for this package of benzonatate 100 mg Capsule?
Bill NDC 71335-1329-03 — the 11-digit billing format is 71335132903. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 71335-1329-3, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71335-1329-03, written without dashes as 71335132903. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71335-1329-03, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (1329) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 9 other package presentations of this same product, including 10 capsules (71335-1329-00), 14 capsules (71335-1329-08), 15 capsules (71335-1329-04). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Bryant Ranch Prepack is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 13 words ▾

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

⏱️ Dosage and Administration 65 words ▾

DOSAGE AND ADMINISTRATION Adults and Children over 10 years of age: Usual dose is one 100 mg, 150 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.

⛔ Contraindications 7 words ▾

CONTRAINDICATIONS Hypersensitivity to benzonatate or related compounds.

⚠️ Warnings 130 words ▾

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 ).

🤒 Adverse Reactions 72 words ▾

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.

🤰 Pregnancy 49 words ▾

Usage in Pregnancy PREGNANCY CATEGORY C Animal reproduction studies have not been conducted with benzonatate. It is also not known whether benzonatate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzonatate should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 35 words ▾

Pediatric Use Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.

🆘 Overdosage 207 words ▾

OVERDOSAGE 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 severe intoxication from overdosage.

Do not use CNS stimulants.

🧬 Clinical Pharmacology 61 words ▾

CLINICAL PHARMACOLOGY Benzonatate acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by dampening their activity and thereby reducing the cough reflex at its source. It begins to act within 15 to 20 minutes and its effect lasts for 3 to 8 hours. Benzonatate has no inhibitory effect on the respiratory center in recommended dosage.

📦 How Supplied / Storage and Handling 74 words ▾

HOW SUPPLIED Product: 71335-1329 NDC: 71335-1329-0 10 CAPSULE in a BOTTLE NDC: 71335-1329-1 30 CAPSULE in a BOTTLE NDC: 71335-1329-2 20 CAPSULE in a BOTTLE NDC: 71335-1329-3 100 CAPSULE in a BOTTLE NDC: 71335-1329-4 15 CAPSULE in a BOTTLE NDC: 71335-1329-5 120 CAPSULE in a BOTTLE NDC: 71335-1329-6 60 CAPSULE in a BOTTLE NDC: 71335-1329-7 90 CAPSULE in a BOTTLE NDC: 71335-1329-8 14 CAPSULE in a BOTTLE NDC: 71335-1329-9 40 CAPSULE in a BOTTLE

📋 Description 66 words ▾

DESCRIPTION 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, 150 mg or 200 mg of benzonatate USP. Benzonatate Capsules, USP also contain the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, purified water, methylparaben, propylparaben and titanium dioxide Chemical Structure

💬 Information for Patients 188 words ▾

Information for Patients Swallow benzonatate capsules whole. Do not break, chew, dissolve, cut, or crush Benzonatate Capsules. Release of benzonatate from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur.

If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of food or liquids until the numbness has resolved. If the symptoms worsen or persist, seek medical attention. Keep benzonatate out of reach of children.

Accidental ingestion resulting in death has been reported in children. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. Signs and symptoms may include restlessness, tremors, convulsions, coma and cardiac arrest.

If accidental ingestion occurs, seek medical attention immediately. Overdosage resulting in death may occur in adults. Do not exceed a single dose of 200 mg and a total daily dosage of 600 mg.

If you miss a dose of benzonatate capsule, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of benzonatate at one time.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.