Zonatuss Recall
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Questions & Answers
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.
Legal Issues
There is currently no legal information available for this drug.
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).
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.
Sources