US Drug Label Compliance

Stay fully compliant with the US Drug Label Compliance for homeopathic medicines. Get updates about changes in labelling compliance. As a leading compliance consulting firm, we help you adhere to US drug labelling laws.

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. 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 easier to read and understand to help people compare and select OTC medicines and follow dosage instructions.

Information To Be Available on Drugs Label in US

  • 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

How We Help Meet US Drug Label Compliance Regulations

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

  • Review compliance to confirm no change is needed for package or label 
  • Evaluate human factors methods 
  • Consider consumers and the environment of use 
  • Prepare mock-ups of drug package and labelling 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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