Changes to OTC Medicine Labeling

This past April the U.S. Food and Drug Administration (FDA) decided that the labels on all OTC medicines, including products like fluoride toothpaste, must have clearer and more consistent information. Medicine labels on OTC products have always contained important information about use and safety, but now this information will be easier to read and understand.

All nonprescription, over-the-counter (OTC) medicine labels now have detailed usage and warning information so consumers can properly choose and use the products. The labels will include:

• Active Ingredient – the therapeutic substance in the medicine and the amount of active ingredient per unit.
• Uses – the symptoms or diseases the product will treat or prevent.
• Warnings – when not to use the product or conditions that may require advice from a doctor before taking the product. Also information about possible interactions or side effects.
• Inactive Ingredients – inert substances such as colors or flavors.
• Purpose – the type of product action or category, such as antihistamine, antacid, or cough suppressant.
• Directions – dosage information.
• Other Information – such as how to store the product properly and required information about certain ingredients (such as the amount of calcium, potassium, or sodium the product contains.)
• The expiration date – date after which you should not use the product.
• Lot or batch code – manufacturer information to help identify the product.
• Manufacturer data – Name and address of manufacturer, packer, or distributor.
• Net quantity of contents – how much of the product is in each package.
• Overdose – what to do if an overdose occurs.

The label gives detailed and important information, including changes that may have been made to the product by the manufacturer. Therefore, it’s critical to take the time to read the label and follow the directions carefully.

Need help keeping up with the changes affecting your labeling? Give us a call at (800) 325-5260.