THE MYSTERY INGREDIENTS - SWEETENERS, FLAVORINGS, DYES, AND PRESERVATIVES IN ANALGESIC ANTIPYRETIC, ANTIHISTAMINE DECONGESTANT, COUGH AND COLD, ANTIDIARRHEAL, AND LIQUID THEOPHYLLINE PREPARATIONS

Objective. Pharmaceutical preparations may contain a variety of excipi ents (''inert ingredients''). These excipients are generally inactive; however, rare adverse effects caused by excipients have been reported . Information about the excipients in a particular preparation is not readily available. Methods. The information about sweeteners, flavorin gs, dyes, and preservatives for the chewable and liquid preparations o f over-the-counter and prescription products of antidiarrhea, cough an d cold, antihistamine/decongestant, analgesic/antipyretic, and liquid theophylline medications was collected. Results. Information about exc ipients in 102 chewable and liquid preparations was compiled. An avera ge preparation contained two sweeteners. Saccharin and sucrose were th e most common sweeteners found-each was present in 52 preparations-fol lowed by sorbitol, glucose, fructose, and others. For 36 of the 102 pr eparations, type of flavoring was not specified. In the remaining prep arations, cherry was the most common flavoring, followed by vanilla an d lemon. Twenty-one different dyes and coloring agents were used. Red dye No. 40 was the most common (42/102), followed by yellow No. 6 (27/ 102). Of the eight preservatives used, sodium benzoate and methylparab ens were present in 42 and 27 of the preparations, respectively. Table s detailing these excipients and adverse effects reported are presente d. Conclusions. The tables should be helpful to physicians in selectin g preparations containing different excipients when an adverse reactio n occurs. The mandatory labeling of excipients in all pharmaceutical p reparations is the only way that physicians and patients can be fully informed.