FDA Final Guidance for Liquid OTCs with Dispensing Devices
The FDA today released its final guidance to firms that manufacture, market, or distribute over-the-counter
(OTC) liquid drug products packaged with cups, droppers, syringes, and spoons to measure and dispense the
doses of medication. The guidance, titled Dosage Delivery Devices for Orally Ingested OTC Liquid Drug
Products, describes how easy-to-use dosage delivery devices and devices that minimize the risk of
unintentional overdose can be provided for OTC medicines such as liquid pain relievers, cold medicine, cough
syrups, and digestion aids.
The FDA issued the guidance because of ongoing concerns about the potential accidental drug overdoses that
can result from the use of dosage delivery devices with markings that are confusing, unclear or inconsistent
with the labeled dosage directions.
Key recommendations in the guidance include:
Dosage delivery devices should be included for all orally ingested OTC liquid drug products.
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 directions for the product and there should not
be any unnecessary markings.
Manufacturers should ensure that dosage delivery devices are used only with the products they are packaged
Liquid measure markings on dosage delivery devices should be clearly visible and not obscured when the liquid
product is added to the device.
According to the FDA, parents and caregivers should follow 10 tips when giving medicine to an infant or child:
1. Always read and follow the Drug Facts label on your OTC medicine.
2. Know the ‘active ingredient’ in your child’s medicine.
3. Give the right medicine, in the right amount, to your child.
4. Talk to your doctor, pharmacist, or nurse to find out what mixes well and what doesn’t.
5. Use the dosing tool that comes with the medicine, such as a dropper or a dosing cup.
6. Know the difference between a tablespoon and a teaspoon.
7. Know your child’s weight.
8. Prevent a poison emergency by always using a child-resistant cap.
9. Store all medicines in a safe place.
10. Check the medicine three times.
NCPIE encourages healthcare professionals and community groups to foster patient–professional communication about medicines. However, NCPIE does not supervise or endorse the activities of any group or professional. Discussion and action concerning medicines are solely the responsibility of the patient and their healthcare professionals, and not NCPIE.
Please consult a licensed health care professional with questions or concerns about your medication and/or condition.