PEDIATRICS Vol. 91 No. 5 May 1993, pp. 927-933
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The Mystery Ingredients: Sweeteners, Flavorings, Dyes, and Preservatives in Analgesic/Antipyretic, Antihistamine/Decongestant, Cough and Cold, Antidiarrheal, and Liquid Theophylline Preparations

Ashir Kumar MD1, Rick D. Rawlings RPh2, and Dana C. Beaman RPh2

1 From the Department of Pediatrics and Human Development, Michigan State University, East Lansing
2 From the Clinical Center Pharmacy, Michigan State University, East Lansing

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 02). 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.

Key Words: inert ingredients • excipients • adverse reactions • sweeteners • flavorings • dyes • coloring agents • preservatives • antihistamines • decongestants • antidiarrheal drugs • antipyretics • analgesics • theophylline • oral medications

Submitted on September 25, 1992
Accepted on December 10, 1992




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