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The Food and Drug Administration on May 4 issued a final guidance to manufacturers and distributors of over-the-counter liquid drugs, addressing an ongoing concern over unclear directions on dosing delivery devices such as spoons, cups, and syringes.
According to a written statement, the FDA issued the guidance titled "Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products" to combat accidental drug overdoses, particularly in children. The guidance "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 key recommendations include:
- All oral OTC liquid drug products should have dosage delivery devices included in their packaging.
- All devices should be marked with calibrated units of liquid measurement (e.g., teaspoon, tablespoon, or mL) 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 with which 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.
The FDA also offered information resources highlighting its Safe Use Initiative, as well as a brochure for parents and caregivers titled "Kids Aren’t Just Small Adults," and a 10-item tip sheet on how to prevent an accidental overdose.
The Food and Drug Administration on May 4 issued a final guidance to manufacturers and distributors of over-the-counter liquid drugs, addressing an ongoing concern over unclear directions on dosing delivery devices such as spoons, cups, and syringes.
According to a written statement, the FDA issued the guidance titled "Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products" to combat accidental drug overdoses, particularly in children. The guidance "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 key recommendations include:
- All oral OTC liquid drug products should have dosage delivery devices included in their packaging.
- All devices should be marked with calibrated units of liquid measurement (e.g., teaspoon, tablespoon, or mL) 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 with which 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.
The FDA also offered information resources highlighting its Safe Use Initiative, as well as a brochure for parents and caregivers titled "Kids Aren’t Just Small Adults," and a 10-item tip sheet on how to prevent an accidental overdose.
The Food and Drug Administration on May 4 issued a final guidance to manufacturers and distributors of over-the-counter liquid drugs, addressing an ongoing concern over unclear directions on dosing delivery devices such as spoons, cups, and syringes.
According to a written statement, the FDA issued the guidance titled "Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products" to combat accidental drug overdoses, particularly in children. The guidance "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 key recommendations include:
- All oral OTC liquid drug products should have dosage delivery devices included in their packaging.
- All devices should be marked with calibrated units of liquid measurement (e.g., teaspoon, tablespoon, or mL) 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 with which 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.
The FDA also offered information resources highlighting its Safe Use Initiative, as well as a brochure for parents and caregivers titled "Kids Aren’t Just Small Adults," and a 10-item tip sheet on how to prevent an accidental overdose.
FROM THE FDA