Active ingredient and purpose on a Drug Facts panel

The first content block below the "Drug Facts" title is the active ingredient section. It is the only part of the panel with a two-column layout: the active ingredient and its amount sit on the left, and a heading called "Purpose" sits at the top right with each ingredient's purpose right-aligned beneath it.

The active ingredient is stated by its established name, followed by the amount in each dosage unit. A common form is "Ibuprofen 200 mg" on the left with "Pain reliever/fever reducer" on the right. Many panels add a qualifier such as "(in each tablet)" or "(in each 5 mL)" after the heading so the amount is unambiguous.

When a product has more than one active ingredient, the heading becomes plural — "Active ingredients" — and each ingredient gets its own left/right line. The purposes still align to the right column so a reader can scan straight down.

The purpose is a short standardized phrase describing what class of drug the ingredient is: "Pain reliever," "Antihistamine," "Antacid," "Cough suppressant," and so on. It is not the same as the "Uses" section, which describes what the product treats.

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.

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Formatting the active ingredient section

  1. Use the established (generic) name of the active ingredient, not a brand name.
  2. State the amount per dosage unit right after the name, e.g. "Cetirizine HCl 10 mg".
  3. Add a unit qualifier after the heading if helpful, e.g. "Active ingredient (in each tablet)".
  4. Put the heading "Purpose" at the top right and right-align each purpose under it.
  5. For multiple actives, pluralize the heading to "Active ingredients" and give each its own line.
  6. Keep purposes to the short standardized drug-class phrases (Pain reliever, Antihistamine, etc.).

Questions

What is the difference between purpose and uses?

Purpose is the drug class of the active ingredient (for example "Antihistamine"). Uses is what the product is labeled to do (for example "temporarily relieves runny nose and sneezing due to hay fever"). They are different headings and both are required.

How do I show the amount for a liquid?

State the amount per dose and the dose volume, for example "Active ingredient (in each 5 mL)" with "Acetaminophen 160 mg" on the line below. This mirrors how the dose is measured in the Directions.

Do inactive ingredients go here too?

No. Inactive ingredients have their own heading near the bottom of the panel and are listed alphabetically. Only active ingredients appear in this two-column section.

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