Excipient (pharmacologically inactive substance)
What is it?
Tartrazine is an azo dye, also known as FD&C Yellow No. 5 and is commonly used as a pharmaceutical colorant. It has been FDA-approved as a drug colorant for internal consumption, external use and around the eye area. In addition to use in pharmaceuticals as a dye, tartrazine is used as a food and cosmetic colorant. FD&C colors are the colors certified for use by the U.S. FDA, in the drug, food and cosmetic industry.
Over-the-counter and prescription drugs that contain tartrazine shall bear statements on the label stating that the product contains FD&C Yellow No. 5 (tartrazine) as a color additive or contains color additives including FD&C Yellow No. 5 (tartrazine). They may also state that FD&C Yellow No. 5 (tartrazine) may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. This warning statement shall appear in the "Precautions" section of the labeling.
Tartrazine hypersensitivity reactions include headaches, asthma attacks, itching or hives, insomnia, and hyperactivity.
Tartrazine is often associated with allergies and hypersensitivity reactions, particularly in patients with asthma or aspirin intolerance. Tartrazine hypersensitivity reactions include headaches, asthma attacks, itching or hives, insomnia, and hyperactivity. The avoidance of tartrazine to prevent allergic asthma in these patients is controversial. A Cochrane Review from 2006 suggests that exclusion of tartrazine from the diets of patients with asthma does not worsen or improve asthma symptoms.  
 Electronic Code of Federal Registers. Title 21: Food and Drugs. Part 74. Listing of color additives subject to certification. Subpart B. Drugs. Accessed online October 19, 2011. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=3cebab99372b0496f3e6d22cefed18da&rgn=div8&view=text&node=21:18.104.22.168.22.214.171.124&idno=21