Label: TESSALON- benzonatate capsule 

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated 08/13

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  • 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.

    tessalon-01.jpg

    Each TESSALON Perle contains:

    Benzonatate, USP 100 mg

    TESSALON Perles (capsules) also contain: D&C Yellow 10, gelatin, glycerin, methylparaben and propylparaben.

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  • 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.

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  • INDICATIONS AND USAGE

    TESSALON is indicated for the symptomatic relief of cough.

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  • CONTRAINDICATIONS

    Hypersensitivity to benzonatate or related compounds.

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  • 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 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).

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  • 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.

    Usage in Pregnancy

    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.

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  • 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.

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  • 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.

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  • 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.

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  • HOW SUPPLIED

    Perles, 100 mg (yellow);

    bottles of 100

    NDC 0069-0122-01

    Imprint: T.

    Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

    PROTECT FROM LIGHT
    Dispense in tight (USP), child-resistant containers.

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  • SPL UNCLASSIFIED SECTION

    Mfd by

    Catalent Pharma Solutions

    St. Petersburg, Florida 33716

    Dist. by

    Pfizer

    Madison, New Jersey 07940

    ©2013 Pfizer Inc.

    LBL-00000397
    Version 5.0

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  • PRINCIPAL DISPLAY PANEL - 100 mg Bottle Label

    NDC 0069-0122-01

    Pfizer

    Tessalon®
    (benzonatate, USP)
    perles

    100 mg

    100 Perles
    Rx only

    PRINCIPAL DISPLAY PANEL - 100 mg Bottle Label
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  • INGREDIENTS AND APPEARANCE
    TESSALON 
    benzonatate capsule
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0069-0122
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZONATATE (BENZONATATE) BENZONATATE 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10  
    GELATIN  
    GLYCERIN  
    METHYLPARABEN  
    PROPYLPARABEN  
    Product Characteristics
    Color YELLOW Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code T
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0069-0122-01 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA011210 02/10/1958
    Labeler - Pfizer Laboratories (134489525)
    Establishment
    Name Address ID/FEI Business Operations
    Catalent Pharma Solutions, LLC 051762268 ANALYSIS(0069-0122), MANUFACTURE(0069-0122), PACK(0069-0122), REPACK(0069-0122)
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