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Adverse Reactions/Side Effects The following important adverse reactions are described below and elsewhere in the labeling: Lactic Acidosis [see Boxed Warning and Warnings and Precautions (5.1)] Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions (5.2)] Volume Depletion [see Warnings and Precautions (5.3)] Urosepsis and Pyelonephritis [see Warnings and Precautions (5.4)] Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions (5.5)] Necrotizing Fasciitis of the Perineum (Fourniers Gangrene) [see Warnings and Precautions (5.6)] Vitamin B12 Concentrations [see Warnings and Precautions (5.7)] Genital Mycotic Infections [see Warnings and Precautions (5.8)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice

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It was extracted from dried leaves of green tea according to pre-set standard procedures

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Because the label describes your preparation specifically