Excipients are inactive substances required for the preparation of pharmaceutical forms. The efficacy, safety, and quality of syrup formulations depend on their composition, including excipients. Oral H1 antihistamine syrup formulations are most commonly used for pediatric and geriatric populations. Forty-one oral H1 antihistamine syrup formulations were initially identified. Of these, 30 formulations with complete excipient information in their patient information leaflets (PILs) were included in the final analysis, while 11 formulations were excluded due to incomplete excipient data. The frequency of each excipient class was determined. The associations between the sweeteners or preservatives used in the analyzed oral H1 antihistamine syrup formulations and H1 antihistamine classes were observed. These associations are exploratory in nature and do not reflect causal relationships; they should be interpreted with caution because of the small sample size and lack of homogeneity. This assessment is based solely on the available descriptive information, without data on the concentrations of the excipients. In the analyzed oral H1 antihistamine syrup formulations, propylene glycol, sorbitol, sodium benzoate, strawberry flavor, Sunset Yellow FCF, and citric acid/sodium citrate were the most commonly used co-solvent, sweetener, preservative, flavoring agent, colorant, and buffering agent, respectively. The results of this study illustrate the patterns of excipient use only within the formulations that were analyzed.
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