FD&C Yellow No. 6

Excipient (pharmacologically inactive substance)

What is FD&C Yellow No. 6?

FDA has regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. FD&C Yellow No. 6 (also known as sunset yellow) is a colorant used in drug dosage forms such as tablets and capsules. It is also approved for use in foods and cosmetics. FD&C Yellow No. 6, a water-soluble, monoazo dye, imparts a reddish-yellow color to medicinal dosage forms. Animals studies have not reported a carcinogenic (cancer-causing) potential for FD&C Yellow No. 6.[1] [2]

[1] Huff J.Environ. Health Perspect. FD&C Yellow No. 6. 1982.45:209-10. Accessed 10/20/2011. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1569019/?page=2

[2] U.S. Food and Drug Administration. Color Additives: FDA's Regulatory Process and Historical Perspectives. Accessed 10/20/2011. http://www.fda.gov/ForIndustry/ColorAdditives/RegulatoryProcessHistoricalPerspectives/default.htm

Top Medications Containing FD&C Yellow No. 6