Label: BENZONATATE- benzonatate capsule 

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

Drug Label Information

Updated 07/14

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  • 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.



    Chemical Structure


    Each soft gelatin capsule, for oral administration, contains 100 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.


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  • 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.

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  • INDICATIONS AND USAGE

    Benzonatate is indicated for the symptomatic relief of cough.

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  • CONTRAINDICATIONS

    Hypersensitivity to benzonatate or related compounds.

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  • 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 in combination with other prescribed drugs.

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  • PRECAUTIONS

    Benzonatate is chemically related to anesthetic agents of the para-aminobenzoic 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.

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  • 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.

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  • 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.

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  • 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 is administered to a nursing woman.

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  • Carcinogenesis, mutagenesis, impairment of fertility:

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

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  • Pediatric Use:

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

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  • 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.

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

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  • 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.

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  • DOSAGE AND ADMINISTRATION

    Adults and Children over 10 years of age: 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.

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  • Benzonatate Pearls 200mg
  • INGREDIENTS AND APPEARANCE
    BENZONATATE 
    benzonatate capsule
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63629-4126(NDC:67877-106)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZONATATE (BENZONATATE) BENZONATATE 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10  
    GELATIN  
    GLYCERIN  
    WATER  
    METHYLPARABEN  
    PROPYLPARABEN  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color yellow Score no score
    Shape CAPSULE Size 19mm
    Flavor Imprint Code ASC;106
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63629-4126-1 30 in 1 BOTTLE
    2 NDC:63629-4126-2 100 in 1 BOTTLE
    3 NDC:63629-4126-3 45 in 1 BOTTLE
    4 NDC:63629-4126-4 20 in 1 BOTTLE
    5 NDC:63629-4126-5 15 in 1 BOTTLE
    6 NDC:63629-4126-6 21 in 1 BOTTLE
    7 NDC:63629-4126-7 60 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040749 07/25/2007
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    Name Address ID/FEI Business Operations
    Bryant Ranch Prepack 171714327 REPACK(63629-4126), RELABEL(63629-4126)
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