US Drug Label Compliance

An over the counter (OTC) medicine label is a compilation of information about a product written by the manufacturer and approved by the FDA. The FDA regulates drug labels and assures all drugs sold in the US are safe, wholesome, and properly labeled. The label contains information to educate people about what the medicine can do, who can take it, and how to use it. 

The label also contains usage and safety information. As per US Drug Label Compliance, the information available on the label must be easy to read and understand to help people compare and select OTC medicines and follow dosage instructions.

• Name of active ingredients and their amount in each dosage unit
• Purpose of the drug, indications (uses) for the medicine
• Specific warnings, such as when the product should be and should not be used
• Side effects that could occur after taking the medicine
• Substances, ingredients, or activities to avoid
• Dosage instructions-when, how, and how often to use the product
• Information to enable people to avoid ingredients that may cause an allergic reaction

1. It must be safe
2. It must be effective
3. It must be for a health condition that can be managed without being supervised by a health care professional i.e., Advil or Tylenol for pain or Pepto Bismol for well you know.