US Drug Label Compliance

Stay fully compliant using our US drug label compliance solutions for over-the-counter drugs and homeopathic medicines. Get updates about changes to labeling requirements. As a leading compliance consulting firm, we help you adhere to US drug labeling requirements.

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. Drug labels contain 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 requirements, the information available on the label must be easy to read and understand to help people compare and select OTC medicines that are right for them, and to help follow dosage instructions.

Information that should be present on a US Drug Label:

  • 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
US Drug Label Compliance Regulations

We Can Help You Comply With US Drug Label Regulations

At Quality Smart Solutions, you will be fully supported by dedicated former FDA officials, who are proficient in helping you adhere to the US Drug Label regulations. We help:

  • Review compliance requirements to confirm no change is needed for your packages/labels
  • Consider consumers and the environment of use to determine if additional directions for use or warning are required
  • Prepare mock-ups of drug packaging and labeling if required

Frequently Asked Questions

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.
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