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U.S. Department of Health and Human Services Office of Disease Prevention and Health Promotion

Guidance for Industry-Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products

About this resource:

Non-Systematic Review

Source: Food and Drug Administration

Last Reviewed: 2011

Workgroups: Medical Product Safety Workgroup

Measuring the correct dose of an over the counter (OTC) medicine helps make sure the medicine works as intended and helps prevent accidental overdoses. In this guidance for industry, the U.S. Food and Drug Administration (FDA) offers recommendations for drug manufacturers on labeling dosage delivery devices for OTC liquid drug products. For example, labelling on dosage devices should:

  • Clearly correspond to the medicine’s dosage directions
  • Use language consistent with the dosage directions (for example, “teaspoon” vs. “tsp”)
  • Contain all necessary liquid measure markings, but avoid markings that aren’t part of the dosage directions
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Objectives related to this resource (1)

Reduce emergency department visits for medication overdoses in children under 5 years — MPS‑01
Little or no detectable change

Suggested Citation

1.

Food and Drug Administration. (2011). Guidance for Industry-Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products. Retrieved from https://www.fda.gov/media/78087/download.