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the label also warns that rash, hives, or swelling of the face, mouth, lips, or tongue can signal a hypersensitivity reaction requiring emergency care, though no generalized allergic reactions were documented in the original trials Because current supply comes only from compounded preparations rather than an FDA-verified finished product, potency, purity, and sterility can vary by pharmacy, and unregulated online sources carry added contamination or mislabeling risk