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FDA Guidance for Industry: Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery



This guidance applies to single-ingredient aspirin, buffered aspirin, and aspirin in combination with an antacid, labeled with cardiovascular related imagery marketed under the Tentative Final Monograph (TFM) for Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) Drug Products for OTC Human Use (53 FR 46204, November 16, 1988).

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