Public Notification: Triple MiracleZen Plus 1500 mg contains hidden drug ingredients
[12-28-2015] The Food and Drug Administration (FDA) is advising consumers not to purchase or use Triple MiracleZen Plus 1500 mg, a product promoted and sold for sexual enhancement on various websites and in some retail stores.
FDA laboratory analysis confirmed that Triple MiracleZen Plus 1500 mg contains sildenafil, tadalafil and dapoxetine. Sildenafil and tadalafil, the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, are used to treat erectile dysfunction (ED). These undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Dapoxetine is an active ingredient not approved by FDA, and therefore its safety and efficacy have not been established.
- Complete and submit the report online at MedWatch Online Voluntary Reporting Form, or;
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
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