FD&C Yellow No. 10

Excipient (pharmacologically inactive substance)

What is FD&C Yellow No. 10?

FD&C Yellow No. 10 is not approved as a food color additive in the US, but may be used in products outside the US. D&C Yellow No. 10 is a color additive used for drug dosage forms such as tablets and capsules. FDA performs regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. D&C Yellow No. 10 may be safely used as a color additive when following FDA specifications.[1] [2]

[1] 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=c387334e82029536a53dde1171ba5481;rgn=div5;view=text;node=21%3A1.0.1.1.27;idno=21;cc=ecfr#21:1.0.1.1.27.2.31.35

[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/RegulatoryProcessHistoric

Top Medications Containing FD&C Yellow No. 10

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