package insert
[ˈpækɪdʒ ˈɪnsɜrt]
nounpl: package inserts
bula
1. An informational document included inside or attached to a medication or pharmaceutical product that provides instructions for use, dosage, side effects, warnings, and other important safety information.
The package insert warned patients about potential allergic reactions to the antibiotic.
A bula alertava os pacientes sobre possíveis reações alérgicas ao antibiótico.
2. Any instructional or informational sheet included with a consumer product or device explaining how to use it safely and effectively.
Read the package insert before assembling the furniture.
Leia a bula antes de montar o móvel.
In Brazil, the 'bula' is a legally required document for all medications sold in pharmacies and is often consulted by patients and healthcare professionals. Brazilian regulations mandate clear, comprehensive bulas in Portuguese. In the US, package inserts for prescription medications are highly regulated by the FDA and contain detailed pharmacological and safety information primarily for healthcare providers, while over-the-counter medications have simpler consumer-facing labels.
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