FDA's Guidance for Liquid OTC Drug Products


Yesterday, the U.S. Food and Drug Administration released its final guidance to firms that manufacture, market, or distribute over-the-counter (OTC) liquid drug products.

Liquid OTC are a potential source for unintentional (accidental) overdoses, especially in children. OTC medications are involved in approximately one-third of ED visits among children under the age of 12. Over 80% of ED visits among children under the age of 12 are due to unsupervised children taking medications on their own and 10% of ED visits in this age group are due to medication errors.

Karen Weiss, M.D., program director for the Center for Drug Evaluation and Research’s Safe Use Initiative, stated “Accidental medication overdose in young children is an increasingly common, but preventable public health problem.”

The FDA guidance, titled Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products, focuses on improved delivery devices which are clearly marked.


OTC medication which come in liquid form include liquid pain relievers, cold medicine, cough syrups, and digestion aids.

Key recommendations in the guidance include:

  1. Dosage delivery devices should be included for all orally ingested OTC liquid drug products.
  2. 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.
  3. Manufacturers should ensure that dosage delivery devices are used only with the products they are packaged with.
  4. Liquid measure markings on dosage delivery devices should be clearly visible and not obscured when the liquid product is added to the device.

Other recommendations are directed at the parents and caregivers who are using the devices to give the medication. The health illiteracy rate among caregivers is high. As many as a third are not health literate. As many as 60% wrongly interpret the instructions on labels.

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.

Food and Drug Administration: Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products Guidance
Centers for Disease Control and Prevention
Many paid caregivers lack health literacy skills; Kevin B. O'Reilly; amednews, May 4, 2011.