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U.S. Department of Health and Human Services

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Public Health Advisory: Consumers Should Not Use Triaminic Vapor Patch

This product is not currently available for purchase in the U.S.

6/20/2006

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 MedWatch Reports, by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500, which may be downloaded, by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or fax [1-800-FDA-0178].

 

Contact FDA

1-800-332-1088
1-800-FDA-0178 Fax
Report a Serious Problem

MedWatch Online

Regular Mail: Use postage-paid FDA Form 3500

Mail to: MedWatch 5600 Fishers Lane

Rockville, MD 20857