FD&C Yellow No. 6 Lake
Excipient (pharmacologically inactive substance)
What is it?
FD&C Yellow No. 6 Lake is a color additive used for drug dosage forms such as tablets and capsules. It is also approved for use in foods and cosmetics. FD&C Yellow No. 6 Lake imparts a reddish-yellow color to medicinal dosage forms.
FDA performs regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. FD&C specifies the color is approved for use in food, drugs and cosmetics. FD&C Yellow No. 6 Lake may be safely used as a color additive when following FDA specifications.
To form lake colors, straight dyes (such as FD&C Yellow No. 6) are mixed with precipitants and salts. Aluminum may be a component. Lakes may be used as color additives for tablet coatings due to their stability. 
 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%3A126.96.36.199.27;idno=21;cc=ecfr#21:188.8.131.52.184.108.40.206
 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
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