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 excipients ("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, flavorings, dyes, and preservatives for the chewable and liquid preparations of over-the-counter and prescription products of antidiarrhea, cough and cold, antihistamine/decongestant, analgesic/antipyretic, and liquid theophylline medications was collected.


RESULTS
Information about excipients in 102 chewable and liquid preparations was compiled. An average preparation contained two sweeteners. Saccharin and sucrose were the most common sweeteners found--each was present in 52 preparations--followed by sorbitol, glucose, fructose, and others. For 36 of the 102 preparations, type of flavoring was not specified. In the remaining preparations, cherry was the most common flavoring, followed by vanilla and 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 methylparabens were present in 42 and 27 of the preparations, respectively. Tables detailing these excipients and adverse effects reported are presented.


CONCLUSIONS
The tables should be helpful to physicians in selecting preparations containing different excipients when an adverse reaction occurs. The mandatory labeling of excipients in all pharmaceutical preparations is the only way that physicians and patients can be fully informed.
Kumar
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A
Dept of Pediatrics and Human Development, Michigan State University, East Lansing 48824-1317.
Rawlings
R D
RD
Beaman
D C
DC
D000700:Analgesics / Q000737:chemistry*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000737:chemistry; D000930:Antidiarrheals / Q000737:chemistry*; D004396:Coloring Agents / Q000009:adverse effects / Q000032:analysis; D004342:Drug Hypersensitivity / Q000209:etiology; D005421:Flavoring Agents / Q000009:adverse effects / Q000032:analysis; D006634:Histamine H1 Antagonists / Q000737:chemistry*; D006801:Humans; D014663:Nasal Decongestants / Q000737:chemistry*; D011310:Preservatives, Pharmaceutical / Q000009:adverse effects / Q000032:analysis; D013549:Sweetening Agents / Q000737:chemistry; D013806:Theophylline / Q000737:chemistry*
D000700:Analgesics; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000930:Antidiarrheals; D004396:Coloring Agents; D005421:Flavoring Agents; D006634:Histamine H1 Antagonists; D014663:Nasal Decongestants; D011310:Preservatives, Pharmaceutical; D013549:Sweetening Agents; D013806:Theophylline