Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; amendment of monograph for OTC nasal decongestant drug products. Final rule.Fed Regist. 2006 Aug 01; 71(147):83358[sic., should be 43358]-63.FR
The Food and Drug Administration (FDA) is issuing a final rule to amend the final monograph (FM) for over-the-counter (OTC) nasal decongestant drug products (drug products used to relieve nasal congestion due to a cold, hay fever, or other upper respiratory allergies) to add phenylephrine bitartrate (PEB), both individually and in combination drug products in an effervescent dosage form, as generally recognized as safe and effective (GRASE). An effervescent dosage form is intended to be dissolved in water before taking by mouth. This final rule is part of FDA's ongoing review of OTC drug products.