Label: BENZONATATE capsule

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

Drug Label Information

Updated April 14, 2021

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  • DESCRIPTION

    Benzonatate capsules, USP, 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.

    Structural Formula

    Each benzonatate capsule for oral administration contains 100 mg or 200 mg of benzonatate. In addition, each capsule also contains the following inactive ingredients: gelatin, glycerin, noncrystallising sorbitol solution, methylparaben, propylparaben and purified water.

  • CLINICAL PHARMACOLOGY

    Benzonatate capsules act 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 capsules have no inhibitory effect on the respiratory center in recommended dosage.

  • INDICATIONS AND USAGE

    Benzonatate capsules are indicated for the symptomatic relief of cough.

  • CONTRAINDICATIONS

    Hypersensitivity to benzonatate or related compounds.

  • 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 benzonatate capsules in combination with other prescribed drugs.

    Accidental Ingestion and Death in Children

    Keep benzonatate capsules out of reach of children. Accidental ingestion of benzonatate capsules 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).

  • 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 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 capsules 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 dosage of 600 mg. If you miss a dose of benzonatate capsules, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of benzonatate capsules at one time.

    Usage in Pregnancy

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

    Carcinogenesis, mutagenesis, impairment of fertility

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

    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 Benzonatate Capsules 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 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 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 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 Capsules should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.

  • HOW SUPPLIED

    Benzonatate capsules USP, 100 mg are light yellow-colored, round-shaped soft gelatin capsules, imprinted with "Z" containing pale yellow-colored clear viscous liquid and are supplied as follows:
    Unit dose packages of 100 (10 x 10) NDC 68084-214-01

    Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]

    FOR YOUR PROTECTION: Do not use if blister is torn or broken.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

  • PACKAGING INFORMATION

    American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Zydus Pharmaceuticals (USA) Inc. as follows:
    (100 mg/100 UD) NDC 68084-214-01 packaged from NDC 68382-247

    Distributed by:
    American Health Packaging
    Columbus, OH 43217

    8221401/0321

  • Package/Label Display Panel – Carton – 100 mg

    100 mg Benzonatate Capsules Carton

    NDC 68084- 214-01

    Benzonatate
    Capsules, USP

    100 mg

    100 Capsules (10 x 10) Rx Only

    Each Capsule Contains:
    Benzonatate, USP …………………………………. 10 mg

    Usual Dosage: See package insert for full prescribing
    information.

    Store at 20° to 25°C (68° to 77°F); excursions permitted
    between 15° to 30°C (59° to 86°F) [see USP Controlled
    Room Temperature].

    Keep this and all drugs out of the reach of children.

    FOR YOUR PROTECTION: Do not use if blister is torn or
    broken.

    The drug product contained in this package is from
    NDC # 68382-247, Zydus Pharmaceuticals (USA) Inc.

    Distributed by:
    American Health Packaging
    Columbus, Ohio 43217

    801054
    0224101/0321

  • Package/Label Display Panel – Blister – 100 mg

    100 mg Benzonatate Capsule Blister

    Benzonatate
    Capsule, USP

    100 mg

  • INGREDIENTS AND APPEARANCE
    BENZONATATE 
    benzonatate capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68084-214(NDC:68382-247)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR) BENZONATATE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Coloryellow (LIGHT YELLOW) Scoreno score
    ShapeROUND (ROUND) Size3mm
    FlavorImprint Code Z
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68084-214-0110 in 1 CARTON05/01/2021
    1NDC:68084-214-1110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04059710/03/2011
    Labeler - American Health Packaging (929561009)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Health Packaging929561009repack(68084-214)