Questions and Answers on Guidance for Industry: Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products

On May 4, 2011, the U.S. Food and Drug Administration (FDA) issued a final guidance for industry with the Agency’s recommendations for improving dosage delivery devices, such as cups and droppers, for over-the-counter (OTC) (i.e., non-prescription) orally ingested liquid drug products. The intent of this guidance is to suggest ways manufacturers can improve their labeling in order to minimize the risk of accidental overdose.

The following questions and answers provide background on accidental overdose of OTC liquid drug products and describe the steps manufacturers and consumers can take to reduce medication dosing errors.

Q1. What are over-the-counter (OTC) orally ingested liquid drug products?

Q2. What are dosage delivery devices?

Q3. Why is FDA concerned about over-the-counter (OTC) dosage delivery devices?

Q4. Why did FDA issue a guidance for industry on dosage delivery devices?

Q5. What are the main points of the guidance?

Q6. How will FDA determine if this guidance is effective in minimizing the risk of accidental overdose of over-the-counter (OTC) orally ingested liquid drug products?

Q7. What can consumers do to help assure the safe use of over-the-counter (OTC) orally ingested liquid drug products?

Q1. What are over-the-counter (OTC) orally ingested liquid drug products?

A. Over-the-counter (OTC) drugs are those medications sold without a prescription in drug stores, grocery stores, and other retail establishments. The orally ingested liquid drug products are medications that are in a liquid form; such as a syrup, solution, suspension, or elixir; that are intended to be consumed by swallowing (orally ingested). Examples of these products include the liquid forms of pain relievers, cold medicine, cough syrups, and digestion aids. Liquid oral drug products are often intended for use in children and require careful administration by a parent or adult caregiver using an appropriate dosage delivery device.

Q2. What are over-the-counter (OTC) dosage delivery devices?

A. Calibrated cups, spoons, needleless syringes, and droppers are examples of dosage delivery devices used to administer orally ingested liquid drug products. These dosage devices are generally marked in measured increments such as tablespoons (tbsp), teaspoons (tsp), or milliliters (mL). Dosage delivery devices are intended to assist consumers in measuring the appropriate dose of a liquid oral drug product and should be used only with the products they are packaged with.

Q3. Why is FDA concerned about over-the-counter (OTC) dosage delivery devices?

A. FDA is concerned about over-the-counter (OTC) dosage delivery devices because accidental dosing errors can result from markings on the device that are misleading or inconsistent with the dosage directions listed on the product package. For example, FDA identified and monitored the recall of a potentially unsafe nasal decongestant product where the directions stated, “take 2 teaspoonfuls (tsp) every 4-6 hours.” The dosage delivery device packaged with the product did not display a “2 tsp” marking; rather, it displayed a marking for two tablespoonfuls as “2TBS” instead. Misunderstanding or misreading this device marking could potentially lead to a dangerous three-fold increase in the administered dose.

Accidental overdoses can also occur when patients and caregivers cannot read or understand the markings on the dosage delivery device and may improvise and use household utensils such as spoons to measure teaspoon or tablespoon doses. Since household utensils can vary widely in size, patients and caregivers may be administering an inaccurate dose of medicine and may inadvertently under or overdose themselves or the patient.

FDA believes better dosage devices will help minimize these types of accidental dosing errors.

Q4. Why did FDA issue a guidance for industry on over-the-counter (OTC) dosage delivery devices?

A. FDA issued a guidance on over-the-counter (OTC) dosage delivery devices because of safety concerns about the serious risk of accidental drug overdoses, especially in children. Accidental overdosing can be caused by dosage delivery devices with unclear markings or markings that are inconsistent with the labeled dosing instructions. The guidance for industry is aimed at improving the clarity of the markings on dosing devices and the consistency between product labeling and dosing devices by providing recommendations for making liquid dosage delivery devices that are easier for consumers to use and understand.

Better measuring devices for OTC liquid drug products will help patients, parents, and other caregivers use the right amount of these medications – the safest and most effective dose – especially when administering liquid drug products to children.

Q5. What are the main points of the guidance for industry?

A. The main points of the guidance for industry are as follows:

Dosage delivery devices should be included for all orally ingested OTC products that are liquid formulations.
Dosage devices should be marked with calibrated units of liquid measurement (e.g., teaspoon, tablespoon, or milliliter) that are the same as the units of liquid measure specified in the labeled dosage directions on the product packaging and in any written instructions.
If units of liquid measure are abbreviated on the dosage delivery device, the abbreviation used on the device should be the same abbreviation used in the labeled dosage directions, outside packaging (carton labeling), bottle, and any accompanying written instructions.
Any decimals or fractions included on dosage delivery devices should be listed as clearly as possible.
Dosage delivery devices should not have extraneous measurement markings.
Manufacturers should try to ensure that the dosage delivery devices are only used to administer the product they are packaged with.
Dosage delivery devices should not be significantly larger than the largest single dose allowed and should allow accurate delivery of the smallest dose described in the product labeling.
The liquid measure markings on dosage delivery devices should be clearly visible both before and after a liquid product is added to the device.

Q6. How will FDA determine if this guidance is effective in minimizing the risk of accidental overdose of over-the-counter (OTC) orally ingested liquid drug products?

A. FDA routinely monitors and surveys the over-the-counter (OTC) drug marketplace and will take appropriate measures to address OTC liquid drug products that are packaged with misleading dosage delivery devices and may pose serious safety concerns. FDA expects that widespread industry compliance with this guidance will help consumers better understand how to dispense a correct dose of an OTC medication and thereby help to reduce accidental OTC overdoses.

Q7. What can consumers do to help assure the safe use of over-the-counter (OTC) orally ingested liquid drug products?

A. FDA and the Consumer Healthcare Products Association (CHPA) have developed ten tips for patients, parents, and caregivers who are administering over-the-counter (OTC) liquid oral drug products to children.

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