NDC 0069-0122 Tessalon

Benzonatate

NDC Product Code 0069-0122

NDC CODE: 0069-0122

Proprietary Name: Tessalon What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Benzonatate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat coughs caused by the common cold and other breathing problems (e.g., pneumonia, bronchitis, emphysema, asthma). It works by reducing the reflex in the lungs that causes the urge to cough. Use of this medication is not recommended in children younger than 10 years. Discuss the risks and benefits with your doctor.

Product Characteristics

Color(s):
YELLOW (C48330)
Shape: ROUND (C48348)
Size(s):
7 MM
Imprint(s):
T
Score: 1

NDC Code Structure

  • 0069 - Pfizer Laboratories Div Pfizer Inc

NDC 0069-0122-01

Package Description: 100 CAPSULE in 1 BOTTLE

NDC Product Information

Tessalon with NDC 0069-0122 is a a human prescription drug product labeled by Pfizer Laboratories Div Pfizer Inc. The generic name of Tessalon is benzonatate. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Pfizer Laboratories Div Pfizer Inc

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Tessalon Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BENZONATATE 100 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Decreased Tracheobronchial Stretch Receptor Activity - [PE] (Physiologic Effect)
  • Non-narcotic Antitussive - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Pfizer Laboratories Div Pfizer Inc
Labeler Code: 0069
FDA Application Number: NDA011210 What is the FDA Application Number?
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.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 02-10-1958 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Benzonatate

Benzonatate is pronounced as (ben zoe' na tate)

Why is benzonatate medication prescribed?
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 lung...
[Read More]

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Tessalon Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

TESSALON, 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 TESSALON Perle contains:Benzonatate, USP 100 mgTESSALON Perles (capsules) also contain: D&C Yellow 10, gelatin, glycerin, methylparaben and propylparaben.

Clinical Pharmacology

TESSALON 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. TESSALON has no inhibitory effect on the respiratory center in recommended dosage.

Indications And Usage

TESSALON is indicated for the symptomatic relief of cough.

Contraindications

Hypersensitivity to benzonatate or related compounds.

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 TESSALON in combination with other prescribed drugs.

Accidental Ingestion And Death In Children

Keep TESSALON out of reach of children. Accidental ingestion of TESSALON 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).

Precautions

Benzonatate is chemically related to anesthetic agents of the para-amino-benzoic acid class (e.g. procaine; tetracaine) and has been associated with adverse CNS effects possibly related to a prior sensitivity to related agents or interaction with concomitant medication.

Information For Patients

Swallow TESSALON Perles whole. Do not break, chew, dissolve, cut, or crush TESSALON Perles. Release of TESSALON 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 TESSALON 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 TESSALON, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of TESSALON at one time.

Pregnancy Category C

Animal reproduction studies have not been conducted with TESSALON. It is also not known whether TESSALON can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TESSALON should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when TESSALON is administered to a nursing woman.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with TESSALON.

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.

Adverse Reactions

Potential Adverse Reactions to TESSALON 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.

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.

Dosage And Administration

Adults and Children over 10 years of age: Usual dose is one 100 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. TESSALON should be swallowed whole. TESSALON Perles are not to be broken, chewed, dissolved, cut or crushed.

How Supplied

Perles, 100 mg (yellow);bottles of 100NDC 0069 0122 01Imprint: T.

Storage And Handling

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].PROTECT FROM LIGHTDispense in tight (USP), child-resistant containers.

Other

Mfd. by:Catalent Pharma SolutionsSt. Petersburg, Florida 33716Dist. by:PfizerMadison, New Jersey 07940©2013 Pfizer Inc.LBL-00000397 version 5.0 July 201311969401

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