Safety Alerts & Recalls
What does this mean?
This alert is a good reminder for parents to read the directions carefully when giving over-the-counter medicines to their children and infants. 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.
If you have questions about dosage delivery devices or how to measure liquid OTC medicines, please contact a physician, pharmacist, or other healthcare professional.
FDA Provides Guidance for Dispensing Devices and Drugmakers Remove OTC Infant Acetaminophen Drops
The U.S. Food and Drug Administration (FDA) released final recommendations to drugmakers and distributors describing standards for dosage delivery devices such as droppers and dosage cups. These standards will help promote ease-of-use and minimize the risk of unintentional overdose from over-the-counter (OTC) liquid drug products, such as liquid pain relievers, cold medicine, cough syrups, and digestion aids.
Several drugmakers have also announced they will discontinue over-the-counter (OTC) infant drops of medicines containing acetaminophen in an effort to avoid confusion that can lead to dangerous overdoses. Acetaminophen is a key ingredient in Tylenol, Nyquil, and many other OTC medicines sold to combat pain and fever.
Right now, the infant formulations on store shelves contain half of the amount of acetaminophen that is found in regular children’s formula. Parents can accidentally give infants too much of the ingredient if they do not read the instructions carefully or use the dropper with a different formulation of the drug.
The phase out is expected to begin later this year. At that time, the OTC makers will only sell a single concentration for all children under the age of 12, which will contain 160 milligrams per 5 milliliters.
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