FDA Issues Guidelines for Liquid OTC Medicines05/04/11
WEDNESDAY, May 4 (HealthDay News) -- U.S. health officials
issued final guidance Wednesday for the production, marketing and
distribution of liquid over-the-counter drug products that are
measured and dispensed with provided devices such as spoons, cups
The U.S. Food and Drug Administration developed the guidance in
response to concerns about the risk of overdoses when using liquid
over-the-counter (OTC) pain relievers, cold medicines, cough syrups
and digestion aids if the dispensing devices included with the
products have markings that are confusing, unclear or inconsistent
with the dosage directions on the label.
Among the main recommendations in the guidance:
- Dosage dispensing devices should be included with all OTC
liquid drug products that are taken by mouth.
- The dispensing devices should be marked with calibrated units
of liquid measurement (such as teaspoon, tablespoon, or milliliter)
that match the units of measurement specified on the label
directions. The devices should not have any unnecessary
- Companies should ensure that dispensing devices are used only
with the intended products.
- The measure markings on dispensing devices should be clearly
visible when the liquid product is added to the device.
"Accidental medication overdose in young children is an increasingly common, but preventable, public health problem," Dr. Karen Weiss, program director for the Center for Drug Evaluation and Research's Safe Use Initiative, said in an FDA news release.
The FDA also outlined 10 tips that should be followed by parents
and caregivers when giving medicine to an infant or child:
- Read and follow the Drug Facts label on OTC medicines.
- Know the active ingredient in the medicine.
- Use the dosing tool that comes with the medicine.
- Know the difference between a tablespoon and a teaspoon.
- Know your child's weight.
- Give the right medicine, in the right amount.
- Check the medicine three times.
- Ask your doctor, pharmacist or nurse which medicines can or
can't be used at the same time.
- Always use child-resistant caps on medicines.
- Store all medicines in a safe place.
The FDA has more about
buying and using medicines safely.
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