The correct order of Drug Facts warnings
The Warnings section is the most detailed part of a Drug Facts panel, and its internal order is fixed. After any general warnings (such as an allergy alert or a "For external use only" statement), the sub-warnings appear under bold sub-headings in a specific sequence set by 21 CFR 201.66.
The sequence is: "Do not use," then "Ask a doctor before use if," then "Ask a doctor or pharmacist before use if," then "When using this product," then "Stop use and ask a doctor if," then any pregnancy/breast-feeding warning, and finally — always — "Keep out of reach of children."
Not every sub-warning applies to every product, so you include only the ones relevant to your formulation. But when they do apply, they must appear in this order, and the Keep out of reach of children statement is required on every OTC drug panel regardless of the other warnings.
Sub-warnings are separated from each other by hairline rules, while the Warnings heading itself sits below a medium rule that separates it from the Uses section above. This graded system of rules is part of what makes the panel scannable.
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 fixed warning sequence
- General warnings first (e.g. "Allergy alert", "For external use only", flammability).
- Do not use — absolute contraindications.
- Ask a doctor before use if you have — conditions that warrant caution.
- Ask a doctor or pharmacist before use if you are — drug interaction cautions.
- When using this product — what to expect or avoid during use.
- Stop use and ask a doctor if — signs that use should end.
- If pregnant or breast-feeding — the pregnancy/nursing statement, when applicable.
- Keep out of reach of children — always required, with the overdose instruction.
Questions
Is Keep out of reach of children always required?
Yes. Every OTC drug Drug Facts panel must include the Keep out of reach of children statement, typically paired with overdose instructions directing the consumer to a Poison Control Center. Drug Facts Panel Maker adds it automatically and flags input that omits it.
Where do allergy alerts go?
An allergy alert is a general warning and appears near the top of the Warnings section, before the sub-headed warnings like Do not use. Some ingredients (for example ibuprofen or acetaminophen) have specific allergy-alert wording.
Can I combine two sub-warnings under one heading?
No. Each applicable sub-warning uses its own standardized heading in the fixed order. Combining them changes the structure the regulation requires.