FD&C Blue No. 2 Aluminium Lake
Medically reviewed by Drugs.com. Last updated on Nov 7, 2023.
Excipient (pharmacologically inactive substance)
What is it?
FDA performs regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. FD&C Blue No. 2 Aluminum Lake is a FDA-approved color commonly used to dye dosage forms such as tablets and capsules. FD&C Blue No. 2 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. The FDA states that D&C Blue No. 2 Aluminum Lake may be safely used as a color additive when their specifications are followed.
According to the FDA, lakes are formed by reacting straight colors (such as FD&C Blue No. 2 Aluminum) with precipitants and salts. Lakes may be used as color additives for tablet coatings due to their stability.[1][2]
List of medications using FD&C Blue No. 2 Aluminium Lake
- Amphetamine and Dextroamphetamine Extended Release 20 mg
- Amphetamine and Dextroamphetamine Extended Release 10 mg
- Amphetamine and Dextroamphetamine Extended Release 15 mg
- Amphetamine and Dextroamphetamine Extended Release 5 mg
- Chlorpromazine Hydrochloride 25 mg
- Chlorpromazine Hydrochloride 100 mg
- Chlorpromazine Hydrochloride 10 mg
- Eplerenone 50 mg
- Ibuprofen and Famotidine 800 mg / 26.6 mg
- Methenamine Mandelate 500 mg
- Paroxetine Extended-Release 12.5 mg
- Paroxetine Extended-Release 37.5 mg
- Sunitinib Malate 50 mg
- Sunitinib Malate 12.5 mg
- Sunitinib Malate 37.5 mg
- Sunitinib Malate 25 mg
- Welireg 40 mg
- Xpovio 50 mg
- Xpovio 60 mg
- Xpovio 40 mg
References
- 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
- 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.
