Label: BENZONATATE capsule

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 30, 2008

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  • N/A - Section Title Not Found In Database

  • SPL UNCLASSIFIED SECTION

    Rx Only

  • SPL UNCLASSIFIED SECTION

    P5519-1 01/08

  • 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.

    Image from Drug Label Content

    Each benzonatate capsule contains benzonatate, USP, 100 mg or 200 mg.

    Benzonatate capsules, USP also contain gelatin, glycerin, methyl/propyl paraben blend, purified water, and titanium dioxide.

  • 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.

  • INDICATIONS AND USAGE

    Benzonatate capsules, USP are indicated for the symptomatic relief of cough.

  • CONTRAINDICATIONS

    Hypersensitivity to benzonatate or related compounds.

  • WARNINGS

    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.

    Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking benzonatate capsules, USP in combination with other prescribed drugs.

  • 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

    Release of benzonatate from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. Therefore, the capsules should be swallowed without chewing.

    Usage in Pregnancy – Pregnancy Category C

    Animal reproduction studies have not been conducted with benzonatate capsules, USP. It is also not known whether benzonatate capsules, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzonatate capsules, USP 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 benzonatate capsules, USP are administered to a nursing woman.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with benzonatate capsules, USP.

    Pediatric Use

    Safety and effectiveness in children below the age of 10 have not been established.

  • ADVERSE REACTIONS

    Potential adverse reactions to benzonatate capsules, USP 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.

    Rare instances of deliberate or accidental overdose have resulted in death.

  • OVERDOSAGE

    Overdose may result in death.

    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

    If capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly. CNS stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound CNS depression.

    Treatment

    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: Usual dose is one 100 mg or 200 mg capsule t.i.d. as required. If necessary, up to 600 mg daily may be given.

  • HOW SUPPLIED

    Benzonatate capsules, USP 100 mg are round, white soft gelatin capsules, imprinted in black ink “E,” packaged as follows:

    NDC 58177-091-04 bottle of 100 capsules

    NDC 58177-091-08 bottle of 500 capsules

    NDC 58177-091-11 unit dose package of 100 capsules (10 capsules per blister card)

    Benzonatate capsules, USP 200 mg are oval, white soft gelatin capsules, imprinted in black ink “E2,” packaged as follows:

    NDC 58177-092-04 bottle of 100 capsules

    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 a tight, light resistant container as defined in the USP.

    Manufactured by
    AccuCaps
    Windsor, Ontario, Canada
    for
    ETHEX Corporation
    St. Louis, MO 63044 USA

    P5519-1 01/08

  • INGREDIENTS AND APPEARANCE
    BENZONATATE 
    benzonatate capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:58177-091
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzonatate (UNII: 5P4DHS6ENR) (Benzonatate - UNII:5P4DHS6ENR) 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    gelatin (UNII: 2G86QN327L)  
    glycerin (UNII: PDC6A3C0OX)  
    methyl/propyl paraben blend ()  
    water (UNII: 059QF0KO0R)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (WHITE) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code E
    Contains    
    CoatingfalseSymbolfalse
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58177-091-04100 in 1 BOTTLE
    2NDC:58177-091-08500 in 1 BOTTLE
    3NDC:58177-091-11100 in 1 BLISTER PACK
    BENZONATATE 
    benzonatate capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:58177-092
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzonatate (UNII: 5P4DHS6ENR) (Benzonatate - UNII:5P4DHS6ENR) 200 mg
    Inactive Ingredients
    Ingredient NameStrength
    gelatin (UNII: 2G86QN327L)  
    glycerin (UNII: PDC6A3C0OX)  
    methyl/propyl paraben blend ()  
    water (UNII: 059QF0KO0R)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (WHITE) Scoreno score
    ShapeOVAL (OVAL) Size11mm
    FlavorImprint Code E2
    Contains    
    CoatingfalseSymbolfalse
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58177-092-04100 in 1 BOTTLE
    Labeler - ETHEX Corporation