Benzonatate

Redpharm Drug, Inc.
Human Prescription Drug
NDC 67296-1454

Benzonatate is a human prescription drug labeled by 'Redpharm Drug, Inc.'. National Drug Code (NDC) number for Benzonatate is 67296-1454. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Benzonatate drug includes Benzonatate - 200 mg/1 . The currest status of Benzonatate drug is Active.

Drug Information:

Drug NDC:	67296-1454
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Benzonatate
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Benzonatate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Redpharm Drug, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Capsule
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	BENZONATATE - 200 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	01 May, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	15 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA040682
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2024
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	RedPharm Drug, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	283417
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
NUI:	N0000009010 N0000175796
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	5P4DHS6ENR
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Non-narcotic Antitussive [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Decreased Tracheobronchial Stretch Receptor Activity [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class:	Decreased Tracheobronchial Stretch Receptor Activity [PE] Non-narcotic Antitussive [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
67296-1454-3	30 CAPSULE in 1 BOTTLE (67296-1454-3)	01 May, 2018	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Product Elements:

Benzonatate benzonatate d&c yellow no. 10 gelatin, unspecified glycerin methylparaben sodium propylparaben sodium benzonatate benzonatate a6

Boxed Warning:

Boxed warning 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 to 20 minutes and death has been reported within one hour of ingestion. if accidental ingestion occurs, seek medical attention immediately (see overdosage).

Indications and Usage:

Indications and usage benzonatate is indicated for the symptomatic relief of cough.

Dosage and Administration:

Dosage and 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 should be swallowed whole. benzonatate capsules are not to be broken, chewed, dissolved, cut or crushed.

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 âchillyâ sensation; numbness of the chest; hypersensitivity. deliberate or accidental overdose has resulted in death, particularly in children.

Use in Pregnancy:

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:

Pediatric use: safety and effectiveness in children below the age of 10 has not been established. accidental ingestion resulting in death has been reported in children below age 10. keep out of reach of children.

Overdosage:

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 to 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 refluxes 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.

Description:

Description benzonatate, a non-narcotic 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. benzonatate capsules, usp contain 100 mg or 200 mg of benzonatate, usp. benzonatate capsules also contain: d&c yellow no. 10, gelatin, glycerin, methylparaben sodium and propylparaben sodium. structure

Clinical Pharmacology:

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.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility: carcinogenicity, mutagenicity, and reproduction studies have not been conducted with benzonatate.

How Supplied:

How supplied benzonatate capsules, usp are available as: 100 mg (oval, yellow) soft gelatin capsules with imprint âa5â. ndc 62332-426-31 bottles of 100 ndc 62332-426-71 bottles of 500 200 mg (oblong, yellow) soft gelatin capsules with imprint âa6â. ndc 62332-427-31 bottles of 100 ndc 62332-427-71 bottles of 500 store at 20Â° to 25Â°c (68Â° to 77Â°f); excursions permitted to 15Â° to 30Â°c (59Â° to 86Â°f) [see usp controlled room temperature]. dispense in tight, light-resistant container as defined in the usp. to report suspected adverse reactions, contact alembic pharmaceuticals limited at 1-866-210-9797 or fda at 1-800-fda-1088 or www.fda.gov/medwatch manufactured by: swiss caps ag kirchberg, switzerland manufactured for: alembic pharmaceuticals, inc. bedminster, nj 07921, usa revised: 08/2021

Information for Patients:

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 to 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 dose of 600 Read more...

mg. if you miss a dose of benzonatate, skip that dose and take the next dose at the next scheduled time. do not take 2 doses of benzonatate at one time.

Package Label Principal Display Panel:

Package label.principal display panel - 100 mg ndc 62332- 426 -31 benzonatate capsules, usp 100 mg rx only 100 capsules alembic 100 capsules

Package label.principal display panel - 200 mg ndc 62332- 427 -31 benzonatate capsules, usp 200 mg rx only 100 capsules alembic 100 capsules

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.