Label: BENZONATATE capsule

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

Drug Label Information

Updated August 7, 2024

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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. Each Benzonatate ...
  • CLINICAL PHARMACOLOGY
    Benzonatate Capsule acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by dampening their activity and thereby reducing the cough ...
  • INDICATIONS AND USAGE
    Benzonatate Capsule 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 ...
  • 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 ...
  • ADVERSE REACTIONS
    Potential Adverse Reactions to Benzonatate Capsules may include: Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia ...
  • 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 ...
  • 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 ...
  • HOW SUPPLIED
    Benzonatate Capsules USP , 100 mg are available as yellow, oval soft gelatin capsules with '1' imprinted in white ink. Bottles of 100: NDC 51224-010-50 - Bottles of ...
  • SPL UNCLASSIFIED SECTION
    Rev. 2616 - Manufactured by: CSPC-NBP Pharmaceutical Co., Ltd. Shijiazhuang, Hebei, China, 052160 - Manufactured for: TAGI Pharma, Inc ...
  • PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label
    NDC 51224-010-50 - Benzonatate - Capsules USP - 100 mg - Rx only - 100 CAPSULES - CSPC - ® tagiPHARMA - That's A Good Idea.
  • PRINCIPAL DISPLAY PANEL - 200 mg Capsule Bottle Label
    NDC 51224-001-50 - Benzonatate - Capsules USP - 200 mg - Rx only - 100 CAPSULES - CSPC - ® tagiPHARMA - That's A Good Idea.
  • INGREDIENTS AND APPEARANCE
    Product Information