What goes in the Overdosage section, and where do wrong words hide?
21 CFR 201.57 says the Overdosage section must give the signs, symptoms and laboratory findings of overdosage, possible complications, the amounts in a single dose that ordinarily cause symptoms and that are likely to be life threatening, whether the drug is dialyzable, and recommended treatment. Our view: wrong words hide in the symptom names, the treatment steps and the yes-or-no statements. In our experience, the section is short and seldom revised, so a correctly spelled wrong word there can survive many label updates. Spellcheck passes it.
This page is general information, not legal or regulatory advice.
For the other sections, see how to proofread a drug label for meaning, section by section. This page covers the prescription Overdosage section.
What the section covers
21 CFR 201.57 says the section must be based on human data, with animal and in vitro data used if human data are unavailable. It must give:
- Signs, symptoms and laboratory findings associated with overdosage.
- Complications that can occur, such as organ toxicity.
- Concentrations in biologic fluids associated with toxicity or death, and factors that influence excretion and the dose response.
- The amount in a single dose ordinarily associated with symptoms of overdosage, and the amount likely to be life threatening.
- Whether the drug is dialyzable.
- Recommended general treatment procedures and specific measures for support of vital functions.
The rule also says unqualified recommendations for which data are lacking for the specific drug or class must not be stated.
Symptom words and treatment steps
Our view: the symptom list is a list of clinical names, and many have look-alike twins. The treatment steps are short instructions where the verb carries the action. A swapped symptom name sends a clinician looking for the wrong sign; a swapped verb changes what they do.
The yes-or-no lines
Our view: whether the drug is dialyzable is a yes-or-no statement. So is a line saying an antidote exists. A dropped or swapped negation flips the answer and the sentence still reads. For reading negations, see wrong words in Contraindications.
Made-up example: an Overdosage line lists "hypotension" among the signs, while the treatment line beside it advises measures for "hypertension". Both words are real, and the section now contradicts itself in the place a clinician reads fastest.
Why rarely revised sections carry errors forward
In our experience, reviewers spend their time on the sections a change touches. A section that hasn't been edited in a long time gets the lightest read, so a wrong word that got in once can be copied forward with it.
A read routine for short, static sections
Practice advice:
- Read the section in full at each label update, even when the update didn't touch it.
- Read each symptom name on its own and confirm it's the sign you'd expect to see.
- Read each yes-or-no line aloud and ask which answer it gives.
- Check that treatment steps agree with the signs listed above them.
- To audit labels already published, see how to audit published labels for wrong words.
This is our reading of public guidance, not legal or regulatory advice.
Sources
Last reviewed: October 18, 2026
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FAQ
What's in the Overdosage section?
21 CFR 201.57 says it must give signs and symptoms of overdosage, complications, threshold amounts, whether the drug is dialyzable, and recommended treatment.
Why do wrong words last in Overdosage?
In our experience, the section is short and seldom edited, so it gets the lightest read at each update.
Which lines in Overdosage are most error-prone?
In our view: symptom names with look-alike twins, treatment verbs, and yes-or-no lines such as whether the drug is dialyzable.
How do I proofread an Overdosage section?
Practice advice: read it in full at each update, check each symptom name and yes-or-no line, and confirm the treatment steps fit the signs.