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The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours, based upon the above dosage guidance.This medicine is available only under a restricted distribution program called the Opioid Analgesic REMS Risk Evaluation and Mitigation Strategy program.

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Do not use a household spoon because you may not get the correct dose.You may report side effects to FDA at 1-800-FDA-1088.

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