FD&C Red No. 40 Aluminium Lake
Excipient (pharmacologically inactive substance)
What is FD&C Red No. 40 Aluminium Lake?
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
Top Medications Containing FD&C Red No. 40 Aluminium Lake
- Amitriptyline Hydrochloride 25 mg (United Research Laboratories/Mutual Pharmaceutical Company)
- Benazepril Hydrochloride 10 mg (Ethex Corporation)
- Cartia XT 120 mg (Andrx Pharmaceuticals)
- Doxepin Hydrochloride 25 mg (Mylan Pharmaceuticals Inc.)
- Doxepin Hydrochloride 50 mg (Mylan Pharmaceuticals Inc.)
- Doxepin Hydrochloride 10 mg (Mylan Pharmaceuticals Inc.)
- Doxepin Hydrochloride 100 mg (Mylan Pharmaceuticals Inc.)
- Doxepin Hydrochloride 75 mg (Mylan Pharmaceuticals Inc.)
- Fluoxetine Hydrochloride 20 mg (Mallinckrodt Pharmaceuticals)
- Gabapentin 300 mg (Actavis)
- Hydrochlorothiazide 12.5 mg (Mylan Pharmaceuticals Inc.)
- Hydrochlorothiazide and Triamterene 25 mg / 37.5 mg (Sandoz Pharmaceuticals Inc.)
- Hydrochlorothiazide and Triamterene 25 mg / 37.5 mg (Mylan Pharmaceuticals Inc.)
- Nitrofurantoin Macrocrystals 50 mg (Mylan Pharmaceuticals Inc.)
- Nitrofurantoin Macrocrystals 100 mg (Mylan Pharmaceuticals Inc.)
- Omeprazole Delayed Release 20 mg (Dr. Reddy’s Laboratories Inc.)
- Omeprazole Delayed Release 40 mg (Dr. Reddy’s Laboratories Inc.)
- Propranolol Hydrochloride Extended Release 60 mg (Actavis)
- Propranolol Hydrochloride Extended Release 80 mg (Actavis)
- Taztia XT 360 mg (Watson Pharmaceuticals)
