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FDA Issues Final Guidance for Liquid OTC Drug Products With Dispensing Devices
Date:5/4/2011

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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.  

The FDA recommends that anyone with questions about dosage delivery devices or how to measure liquid OTC medicines contact a physician, pharmacist, or other health care professional.

Health care professionals and patients are encouraged to report adverse events, side effects, or product quality problems to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 800-FDA-0178

For more information:

Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products

Kids Aren't Just Small Adults

FDA's Saf
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SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

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