Tessalon label

Tessalon

Tessalon Recall

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Side Effects & Adverse Reactions

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 TESSALON in combination with other prescribed drugs.

Accidental Ingestion and Death in Children

Keep TESSALON out of reach of children. Accidental ingestion of TESSALON 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).

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

TESSALON is indicated for the symptomatic relief of cough.

History

There is currently no drug history available for this drug.

Other Information

TESSALON, 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.

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Each TESSALON Perle contains:

Benzonatate, USP 100 mg

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

Tessalon Manufacturers

  • Pfizer Laboratories
    Tessalon | Pfizer Laboratories
    No Recall

    Tessalon | Pfizer Laboratories

    Tessalon | Pfizer Laboratories

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