Chapter Updates

Content Update for Chapter 11, "Disorders Related to Cold and Allergy"

FDA Approval of OTC Phenylephrine Bitartrate

The following information supplements and updates text in Chapter 11, "Disorders Related to Cold and Allergy," in the Handbook of Nonprescription Drugs, 15th Edition.

Phenylephrine Bitartrate

Phenylephrine bitartrate (PEB) has been approved as a generally recognized as safe and effective (GRASE) active ingredient for nonprescription nasal decongestant drug products. The Food and Drug Administration (FDA) based this decision on its review of in vitro and in vivo studies that demonstrated comparability of PEB and phenylephrine HCl, an approved nonprescription active ingredient, and on reports for PEB products marketed in other countries. FDA amended the final monograph for over-the-counter nasal decongestant drug products to include PEB as an effervescent dosage form, which can be produced as an individual or combination drug product.1 The final rule became effective August 31, 2006. As of June 26, 2007, no nonprescription decongestant products containing PEB were on the market.

Dosage and Dosage Formulations  In addition to PEB as the active ingredient, the effervescent dosage form will contain a mixture of acids (citric acid, tartaric acid) and sodium bicarbonate as inactive ingredients. When dissolved with water, the inactive ingredients interact to release carbon dioxide. The FDA definition of “effervescent dosage form” allows the product to be formulated as a tablet, granule, or powder.1

The table below provides dosage guidelines. (See Chapter 11 for additional information on the properties of nonprescription nasal decongestants.)


Dosage Guidelines for Nonprescription Phenylephrine Bitartrate1
  Dosage (Maximum Daily Dosage)
Drug Adults/Children 12 Years or Older Children 6 to <12 Years Children <6 Years
Phenylephrine bitartrate
 15.6 mg q4h (62.4 mg) 7.8 mg q4h (31.2 mg) Ask a doctor


Reference

  1. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; amendment of monograph for OTC nasal decongestant drug products—final monograph. Federal Register. August 1, 2006;71:43358-63. Available at: http://www.gpoaccess.gov/fr/index.html. Accessed June 26, 2007.