Label: BENZONATATE capsule

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

Drug Label Information

Updated July 15, 2021

If you are a consumer or patient please visit this version.

  • 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

    C30H53NO11        

    Each BENZONATATE Perle contains:
    Benzonatate, USP 100 mg

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

  • 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 is 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 in combination with other prescribed drugs.

    Accidental Ingestion and Death in Children

    Keep BENZONATATE out of reach of children. Accidental ingestion of BENZONATATE 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 BENZONATATE Perles whole. Do not break, chew, dissolve, cut, or crush BENZONATATE Perles. 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 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 BENZONATATE, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of BENZONATATE at one time.

    Usage in Pregnancy

    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.

    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.

    Carcinogenesis, mutagenesis, impairment of fertility

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

    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 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. BENZONATATE should be swallowed whole. BENZONATATE Perles are not to be broken, chewed, dissolved, cut or crushed.

  • HOW SUPPLIED

    Perles, 100 mg (yellow);
    bottles of 100
    NDC 59762-1122-1
    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.

  • SPL UNCLASSIFIED SECTION

    Mfd. by:
    Catalent Pharma Solutions
    St. Petersburg, Florida 33716

    This product's label may have been updated. For current full prescribing information, please visit www.greenstonellc.com.

    Logo

    For more information, call 1-800-438-1985.

    LAB-1416-1.0

    Revised: November 2019

  • PRINCIPAL DISPLAY PANEL - 100 mg Perles Bottle Label

    NDC 59762-1122-1
    100 Perles

    GREENSTONE® BRAND

    benzonatate,
    USP
    perles

    100 mg

    Rx only

    PRINCIPAL DISPLAY PANEL - 100 mg Perles Bottle Label
  • INGREDIENTS AND APPEARANCE
    BENZONATATE 
    benzonatate capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59762-1122
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR) BENZONATATE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59762-1122-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01121001/06/2020
    Labeler - Greenstone LLC (825560733)