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This compound is not intended for human consumption, veterinary use, clinical research involving human subjects, therapeutic use, or diagnostic applications

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The statute authorizes the Secretary to make exceptions to the 2 times rule in unusual cases, such as for low-volume items and services (but the Secretary may not make such an exception in the case of a drug or biological that has been designated as an orphan drug under section 526 of the Federal Food, Drug, and Cosmetic Act)

Common side effects may include headache, facial flushing, nasal congestion, upset stomach, dizziness, or mild vision changes