Drug Facts Labels of US FDA in Easy Language

Introduction of FDA

The Food and Drug Administration (FDA) is the regulatory, scientific, public health and
consumer protection agency responsible for ensuring all human and animal drugs, medical
devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing
animals, tobacco and radiation emitting devices safe, and effective.

The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential
public health task by making sure that safe and effective drugs are available to improve the 2
health of people in the United States. CDER regulates over the counter and prescription drugs, including biological therapeutics and generic drugs.

The mission of the Office of Compliance (OC) is to shield the public from poor-quality, unsafe
and ineffective drugs through proactive compliance strategies and risk-based enforcement
actions. CDER Compliance strives to be a model of efficiency, innovation, and organizational
excellence. CDER Compliance makes strategic and risk-based decisions that are guided by law
and science to communicate clearly with stakeholders, foster global collaboration, promote
voluntary compliance, and take decisive action.

The mission of the Office of Unapproved Drugs and Labeling Compliance (OUDLC) is to develop and implement policies and compliance strategies for protecting the public health by assuring compliance with the new drug and misbranding requirements of the Federal Food, Drug and Cosmetic Act. OUDLC engages in strategic, risk-based, compliance and regulatory activities to shield patients from poor quality, unsafe and ineffective drugs through proactive compliance strategies and risk-based enforcement actions.

The Drug Facts label

The Drug Facts label is a standardized label format required by the U.S. Food and Drug Administration (FDA) for over-the-counter (OTC) drugs. The label provides consumers with important information about the medicine, including its active ingredients, uses, warnings, and directions for use.

Here are some key components of the Drug Facts label:

1. Active ingredients: The active ingredient is the substance in the medicine that produces its therapeutic effect. This section lists the active ingredient(s) and the amount per dosage unit.
2. Uses: This section describes the intended uses of the drug, such as relieving pain or reducing fever.
3. Warnings: The warnings section lists any potential risks associated with the drug. This can include information about possible side effects, interactions with other drugs or medical conditions, and contraindications (situations in which the drug should not be used).
4. Directions for use: This section provides instructions for how to take the drug, including the recommended dosage, how often to take it, and any special instructions (such as taking with food).
5. Other information: This section may include additional information about the drug, such as storage instructions or how to dispose of unused medication.

It is important for consumers to carefully read and follow the Drug Facts label when using OTC medications to ensure safe and effective use. If you have any questions or concerns about a medication, it is always best to consult with your healthcare provider.

FDA Drug Facts Label Requirements

The label must include the active ingredients, purpose, uses, warnings, directions for use, other information, and inactive ingredients. It must also include a statement warning against overdosing and instructions for what to do in case of overdose.

The FDA’s Drug Facts label requirements are based on regulations designed to ensure that consumers have access to clear, concise, and accurate information about over-the-counter (OTC) drugs.

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These requirements are intended to help consumers make informed decisions about the use of OTC drugs and to promote safe and effective use while minimizing the risk of adverse effects. Manufacturers of OTC drugs are responsible for ensuring that their products comply with FDA regulations, including the Drug Facts labeling requirements. It’s important to note that regulations may change over time, so it’s advisable to consult the most up-to-date FDA guidelines and requirements for accurate information.

Drug Safety-Related Labelling Changes Database

The Drug Safety-related Labeling Changes (SrLC) database includes updates to safety information in labeling for human prescription drugs regulated under NDAs and human prescription biological products regulated under BLAs. Updates are available since January 2016. This database includes labeling changes:

From labeling and efficacy supplement approvals (changes initiated by the company or FDA) and Required by the FDA under Section 505(o)(4) of the FD&C Act [safety labeling changes (SLCs)].  See the guidance for industry: Safety Labeling Changes - Implementation of Section 505(o)(4) of the FD&C Act (June 2013).   

This database does not include updates to safety information in:

1. Other sections of the Prescribing Information (e.g., INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION).  For the most recent FDA-approved labeling, please see Drugs@FDA.
2. Labeling for generic drugs regulated under ANDAs.
3. Labeling for FDA-approved prescription products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products).
4. Labeling for nonprescription (e.g., over-the-counter) drugs

This database also does not include safety information from approved Prescribing \ Information under original NDAs and BLAs (see Drugs@FDA) or safety data prior to January 2016. Data prior to January 2016 are available on the MedWatch website.