EVALUATION OF OVER-THE-COUNTER ANTITUSSIVE AND ANTIHISTAMINE DRUG LEAFLETS ACCORDING TO RDC 47/2009

Abstract

Objective: To evaluate whether the package inserts of over-the-counter antitussives and antihistamines comply with the criteria established by RDC No. 47/2009. Methodology: A documentary study was conducted based on the analysis of electronic package inserts of these medications available in ANVISA’s drug database. Package inserts of medications with active registration during the collection period and intended for patients were included, while those directed to healthcare professionals were excluded. Data collection was carried out in April 2025 using a checklist based on RDC No. 47/2009. Information was classified as “compliant,” “non-compliant,” or “not applicable” and analyzed using descriptive statistics. Results: Of the medications analyzed, 26.9% (n=7) presented at least one non-compliant item, most of which were antihistamines (85.7%). The main criterion not met was “Risk of use by non-recommended route of administration” in 81.2% of antihistamines, followed by “Average time to onset of action” in 10% of antitussives and 18.8% of antihistamines. Conclusion: The electronic package inserts analyzed generally comply with RDC No. 47/2009, but still lack essential information that may compromise the safety and appropriate use of these medications.