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Business · 27/09/2001Updated: 10/17/2026 · 1 min read

FDA Final Rule on Cough-Cold Combination Medications with Bronchodilators

Summary

The Food and Drug Administration (FDA) has issued a final rule stating that certain cough-cold combination medications containing bronchodilators are not safe and effective for over-the-counter (OTC) use. These medications, which include products containing analgesics, anticholinergics, antihistamines, and other active ingredients, will be considered misbranded.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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