TABLE 3.

Product Adherence to Low Tier Recommendations from the 2011 FDA Voluntary Guidance and 2009 CHPA Voluntary Guideline^a

		Dosing Directions		Dosing Device
Recommendation	Relevant sample	No./Total No.	% of Relevant Sample	No./Total No.	% of Relevant Sample
Standard abbreviations used for volumetric units (e.g., "mL" used instead of "ml")	Products using abbreviations	59/65	91	49/68	72
Abbreviations for volumetric units on dosing device match the directions (e.g., if “mL” used in directions, “mL” used on device)	Products using abbreviations in directions and on dosing device	--	--	52/65	80
Abbreviations for volumetric units defined (e.g., “mL=milliliter”)b	Products using abbreviations	18/68	26	0/68	0
No extraneous numeric doses appear on the dosing device that do not correspond to amounts in the directions	Products with dosing devices	--	--	19/68	28
Statement included that only enclosed dosing device should be used or mechanism used to secure dosing device to the bottlec	Products with dosing devices	33/68	49	32/68	47

Not applicable denoted by (--)

^aLow Tier recommendations maintain conventional standards of abbreviation and capitalization. They improve clarity and consistency but are not directly linked to potential ≥3-fold dosing errors. Products were assessed for adherence to recommendations in "Guidance for Industry: Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products", US Food and Drug Administration (FDA), May 2011 and "Volumetric Measures for Dosing of Over-the-Counter Oral Liquid Drug Products for Children ≤ 12 years of Age", Consumer Healthcare Products Association (CHPA), November 2009.

^bFDA guidance recommends that abbreviations should be defined on the dosing device (e.g., mL = milliliter) or, if they are not, should be defined in the labeled dosing directions, outside packaging, bottle, and any accompanying written instructions.

^cFDA guidance recommends that manufacturers should try to ensure that the dosing devices are used only with the products with which they are included. Possible ways of accomplishing this are to include a related statement on the drug product's bottle and/or carton labeling and, if possible, on the dosing device or to devise a mechanism to secure the dosing device to the drug product.