Zonatuss label

Zonatuss

Zonatuss Recall

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Side Effects & Adverse Reactions

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.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

ZONATUSSTM (benzonatate capsules, USP) is indicated for the symptomatic relief of cough.

History

There is currently no drug history available for this drug.

Other Information

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 603.00 (av).

benzonatate chemical structure

C30H53NO11 (av.) 603.00 (av.)

Each capsule, for oral administration, contains 150 mg of benzonatate, USP.

In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose cellulose, hydroxypropyl cellulose, microcrystalline cellulose, and silicon dioxide. Capsule shell is composed of gelatin, titanium dioxide, FD&C Blue #1 and D&C Red #28. Imprinting ink is composed of black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.

Zonatuss Manufacturers

  • Zonatuss | Atley Pharmaceuticals
    No Recall

    Zonatuss | Atley Pharmaceuticals

    Zonatuss | Atley Pharmaceuticals

    Adults and Children over 10: Usual dose is one 150 mg capsule three times daily as required. If necessary, up to 600 mg daily may be given.

  • Vertical Pharmaceuticals, Inc.
    Zonatuss | Vertical Pharmaceuticals, Inc.
    No Recall

    Zonatuss | Vertical Pharmaceuticals, Inc.

    Zonatuss | Vertical Pharmaceuticals, Inc.

    Adults and Children over 10 years of age: Usual dose is one 150 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. ZonatussTM capsules should be swallowed whole. ZonatussTM capsules are not to be broken, chewed, dissolved, cut or crushed.