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FD&C Yellow No. 6

Excipient (pharmacologically inactive substance)

Medically reviewed by Drugs.com. Last updated on Jan 29, 2019.

What is it?

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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