Labeling

Our Position

Americans expect and deserve consistent healthcare product labeling, no matter what state they buy or use the items in. It is in every citizen's best interest for the federal government to retain authority over safety labeling standards. Centralized regulation removes variability and guarantees the reliability of health data listed on consumer product packaging from coast to coast.

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Background Summary: Pediatric Acetaminophen Dosing

FDA Announcement of a proposed safety-based Administrative Order (AO) to address dosage strengths of oral, single ingredient, pediatric acetaminophen products. This AO proposal includes the addition of weight and age-based dosing for children under age 12.

three different kinds of dietary supplement capsules

Informed Consumer Decision Making

Voluntary Labeling Program for Dietary Supplements Proposed Pregnancy/Nursing Label Statement

Members of CHPA which market dietary supplements formally initiated a voluntary labeling program on March 22, 2000 which relates to the use of the following label statement on dietary supplement products.

Customer in Store Looking at Label

Transparency

Dietary Supplement Label Database (DSLD)

To address the growing need for more information on dietary supplements available in the market, the Office of Dietary Supplements at the National Institutes of Health has developed the Dietary Supplement Label Database. This valuable resource compiles comprehensive information obtained from the labels of dietary supplement products sold in the United States.

Seniors reading medicine bottle labels in pharmacy
“Flag the Label”

The noteworthy "Flag the Label" program has been adopted by members of the Consumer Healthcare Products Association to aid in alerting consumers to significant changes in nonprescription medicines.

Family with East Asian heritage
Structured Product Labeling

Learn about rules and regulations for structured product labeling of OTC medicines.

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FDA Annual Forecast
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Analysis of Reportability of Changes to NDA OTC Product Labeling

The CHPA Analysis of Reportability of Changes to New Drug Application (NDA) Over-the-Counter (OTC) Product Labeling Table was developed to assess the reportability of changes to OTC products subject to new drug applications.

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FAQs

FAQs About OTC Monograph Reform for Manufacturers
Medicine bottle, syringe, and dosing cup with purple liquid medicine
Background Summary: Risks Associated with Codeine-Containing Cough Medicine

This Proposed Safety Administrative Order addresses the GRASE status of codeine, codeine phosphate, and codeine sulfate as antitussive active ingredients.

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Informed Consumer Decision Making

Disclosure of Added Constituents in Dietary Supplements - Botanical Ingredients

The following information on botanical ingredients should be included in either a bulk botanical raw material specification sheet (for business-to-business transactions) or finished product labeling (when selling directly to consumers).

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