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U.S. Department of Health and Human Services

Safety

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Suprenza (phentermine hydrochloride) orally dissolving tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2013

Summary View

 

WARNINGS AND PRECAUTIONS

Risk of Allergic Reactions due to Tartrazine
  • Suprenza 15 mg and 30 mg ODT contains FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.