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FD&C Red No. 40 Aluminium Lake

Excipient (pharmacologically inactive substance)

Medically reviewed by Drugs.com. Last updated on Oct 16, 2018.

What is it?

FDA performs regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. FD&C Red No. 40 Aluminum Lake is a FDA-approved color commonly used to dye dosage forms such as tablets and capsules. FD&C Red No. 40 Aluminum Lake is approved for use in foods, drugs and cosmetics.

FD&C colors are the colors certified by the FDA for safe use according to specifications. The FD&C notation specifies the color is approved for use in foods, drugs and cosmetics.

Lakes are formed by reacting straight colors (such as FD&C Red No. 40) with precipitants and salts. Lakes may be used as color additives for tablet coatings due to their stability.[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/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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