Drug Facts panel dimensions and graphic rules
Beyond the words, 21 CFR 201.66 controls how the Drug Facts panel looks. Getting the graphics right — the box, the rules, the type sizes — is as much a part of compliance as the content, and it is where a lot of DIY labels go wrong.
The panel is enclosed. A bounding box (or a barbell arrangement of heavy rules top and bottom) frames the whole thing so it reads as a single block distinct from the rest of the label. Inside, the sections are separated by horizontal rules of three graded weights: a heavy bar directly under the "Drug Facts" title, medium rules between the top-level headings, and hairline rules between sub-parts such as the individual warnings.
Type size is regulated with minimums, not fixed values. Most body text has a minimum of 6 point, headings are larger and bold, and the title is the largest element of all. Leading (line spacing) also has minimums so lines do not crowd. The safest approach is to set your text no smaller than the floor and let the layout expand as needed.
For small packages, the rule allows a horizontal, side-by-side layout, and for any panel that does not fit its space, the content continues under a "Drug Facts (continued)" title with the same box and rules. This is why a well-built generator flows overflow onto additional panels automatically rather than shrinking the type below the legal minimum.
Drug Facts Panel Maker lays out your content in the 21 CFR 201.66 format. It is a drafting aid, not regulatory, legal, or medical advice, and does not verify that your dosing, uses, warnings, or claims are correct. Verify every panel with a qualified regulatory person before compliance use.
Build a Drug Facts panel — free draft
The graphic checklist
- Enclose the panel in a bounding box or barbell rules.
- Place a heavy bar directly under the "Drug Facts" title.
- Use medium-weight rules between top-level headings.
- Use hairline rules between sub-parts (e.g. individual warnings).
- Make headings bold and full width; make the title the largest element.
- Keep all text at or above the 6 point minimum — never shrink below it to fit.
- Use high contrast: black text on white.
- Continue overflow under a "Drug Facts (continued)" title instead of shrinking type.
Questions
Can I shrink the type to make everything fit?
Not below the minimum. The type-size floor is a hard requirement. If the content does not fit, the correct fix is a larger panel, a horizontal layout, or a continuation panel — not smaller type. Drug Facts Panel Maker enforces a 6 point floor and flows overflow onto a continued page.
What are the three rule weights for?
They signal hierarchy: the heavy bar sets off the title, medium rules separate the major sections, and hairlines separate the sub-parts within a section. Using a single weight everywhere flattens the structure the format relies on.
Do I have to use a box, or are the barbell rules enough?
The regulation permits a bounding box or the barbell rule arrangement. This tool renders both a bounding box and heavy top/bottom caps so the panel is clearly enclosed either way. Confirm the exact approach for your package with a regulatory professional.