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FDA
Public Health Advisory
Consumers Should Not Use Triaminic Vapor Patch
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This product is not currently available for purchase in the U.S.
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The U.S. Food and Drug Administration (FDA) is warning consumers not
to use Triaminic Vapor Patch. Triaminic Vapor Patch may cause
serious harm if children accidentally take it in by mouth.
Triaminic Vapor Patch is advertised as a cough
suppressant for children two years of age and older and is available
in two scents, mentholated cherry scent and menthol scent. The patch
contains camphor, eucalyptus oil and menthol. The directions on the
label say that the patch is to be applied to the throat or chest to
allow the vapors to reach the nose and mouth. Once applied, the
patch would be within close reach for a child to remove and put in
their mouth. In addition, the cherry scent could entice a child to
chew or swallow the patch. Swallowing products containing camphor or
eucalyptus oils can cause minor symptoms, such as a burning
sensation in the mouth, headache, nausea and vomiting, and more
severe and life-threatening events, such as seizures.
FDA is aware of one harmful event reported in Canada
associated with the use of the identical version of the Triaminic
Vapor Patch; a two year old child, reported to have had a seizure
after chewing on a Triaminic Vapor Patch.
The manufacturer of Triaminic Vapor Patch, Novartis
Consumer Health, is voluntarily recalling Triaminic Vapor Patch.
Unused Triaminic Vapor Patches should be returned to the place where
they were purchased or discarded it in the trash. Consumers
requiring more information about this recall can contact Novartis
Consumer and Professional Affairs Call Center at 1-800-452-0051.
Any adverse reactions experienced with the use of this product,
and/or quality problems should be reported to the FDA's MedWatch
Adverse Event Reporting program online at
www.fda.gov/MedWatch/report.htm, by phone [1-800-FDA-1088], or
by returning the postage-paid FDA form 3500, which may be downloaded
from
www.fda.gov/MedWatch/getforms.htm, by mail to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787 or fax [1-800-FDA-0178].
FDA
News: FDA Warns Consumers Not to Use Triaminic Vapor Patch:
Possible safety and health risks to children.
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Date created: June 20, 2006, updated July 19, 2007 |
