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Limited Use
[what does this mean?]
Generic drug name:
benzonatate
(ben ZONE a tate)
Brand name(s):
TESSALON
GENERIC:
not available
FAMILY:
Cough Suppressants
Find the drug label by
searching at DailyMed.
Pregnancy and Breast-feeding Warnings [top]
Pregnancy Warning
No animal studies were done. Thus, it is not known whether this drug would cause harm to developing fetuses. Use during pregnancy only for clear medical reasons. Tell your doctor if you are pregnant or thinking of becoming pregnant before you take this drug.
Breast-feeding Warning
No information is available from either human or animal studies. It is likely that this drug is excreted in human milk. You should consult with your doctor if you are planning to nurse.
Facts About This Drug [top]
Benzonatate (TESSALON) was first marketed in the U.S. in 1958 and is approved by the Food and Drug Administration (FDA) for the symptomatic relief of cough in patients over 10 years of age. The safety and effectiveness of benzonatate in children under 10 years of age have not been established[1]. The drug is chemically related to anesthetic agents such as procaine and tetracaine.[2]
In the absence of convincing published research on the value of benzonatate in the management of cough due...
Benzonatate (TESSALON) was first marketed in the U.S. in 1958 and is approved by the Food and Drug Administration (FDA) for the symptomatic relief of cough in patients over 10 years of age. The safety and effectiveness of benzonatate in children under 10 years of age have not been established[1]. The drug is chemically related to anesthetic agents such as procaine and tetracaine.[2]
In the absence of convincing published research on the value of benzonatate in the management of cough due to upper respiratory tract infection (URI), we do not recommend it for this use. The best therapeutic role for this drug may be in the management of cough due to pulmonary cancers.[3] Severe hypersensitivity reactions that include cardiovascular collapse have been reported when the benzonatate capsule is sucked or chewed instead of swallowed. Also, because of the drug’s local anesthetic effect, choking can occur when the capsule is sucked or chewed.[2]
You should not use benzonatate or any other drug to treat a mucus-producing cough, because that is the body’s way of ridding itself of secretions and decreasing infection. If you have this kind of cough, drinking lots of liquids, especially soup and other hot drinks, as well as inhaling steam from hot showers and warm baths, will help to loosen secretions and clean and soothe mucous membranes. For more information on treating coughs, see "Cough and Cold" and "Allergy and Hayfever."
Regulatory actions surrounding benzonatate:
2010: In December 2010, the FDA issued a warning to the public concerning the use of benzonatate in children under the age of 10. The warning stated that accidental ingestion of benzonatate by children in this age group could result in death from overdose. Signs and symptoms of overdose of benzonatate include restlessness, tremors, convulsions, coma and cardiac arrest. The advisory further stated that these symptoms can occur rapidly after ingestion (within 15-20 minutes) and that deaths in children have been reported within hours of accidental ingestion[1].
Before You Use This Drug [top]
Tell your doctor if you have or have had:
Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.
When You Use This Drug [top]
How to Use This Drug [top]
Interactions with Other Drugs [top]
Some other drugs that you may be taking (either over-the-counter or prescription) can interact with this one, causing adverse effects. Ask your doctor what these drugs are and let him or her know if you are taking any of them.
Adverse Effects [top]
Call your doctor immediately if you experience:
Call your doctor if these symptoms continue:
Signs of overdose:
If you suspect an overdose, call this number to contact your poison control center: (800) 222-1222.
last reviewed August 31, 2024
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