OTC Drug Facts panel guides
- OTC Drug Facts label requirements — The required content of an OTC Drug Facts label panel under 21 CFR 201.66: active ingredients, purpose, uses, warnings, directions, other information, inactive ingredients, and Questions.
- Active ingredient and purpose on a Drug Facts panel — How to list active ingredients, amounts, and the right-aligned Purpose column on an OTC Drug Facts panel, including how to handle multiple active ingredients.
- The correct order of Drug Facts warnings — The required order of sub-warnings inside the Warnings section of an OTC Drug Facts panel, from Do not use through Keep out of reach of children.
- 21 CFR 201.66 explained — A plain-language explanation of 21 CFR 201.66, the FDA rule that defines the content and graphic format of the OTC Drug Facts label panel.
- Drug Facts panel dimensions and graphic rules — The graphic specification of the Drug Facts panel: minimum type size, the barbell and graded rules, the bounding box, and how to handle small packages and overflow.