D&C Yellow No. 10 Aluminium Lake
Excipient (pharmacologically inactive substance)
What is D&C Yellow No. 10 Aluminium Lake?
FDA performs regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. D&C Yellow No. 10 Aluminum Lake is a FDA-approved color commonly used to dye dosage forms such as tablets and capsules. D&C Yellow No. 10 Aluminum Lake is approved for use in drugs and cosmetics but it is not approved as a colorant for food.
FD&C colors are the colors certified for use by the U.S. FDA in the food, drug, and cosmetic industry. The D&C notation specifies the color is approved only for drugs and cosmetics. The FDA states that D&C Yellow No. 10 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 dyes (such as D&C Yellow No. 10) 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 D&C Yellow No. 10 Aluminium Lake
- Acetaminophen and Pentazocine Hydrochloride 650 mg / 25 mg (Watson Pharmaceuticals)
- Alprazolam Extended Release 1 mg (Actavis)
- Aspirin and Oxycodone Hydrochloride aspirin 325 mg / oxycodone hydrochloride 4.5 mg / oxycodone terephthalate 0.38 mg (Watson Pharmaceuticals)
- Bumetanide 1 mg (IVAX Pharmaceuticals Inc.)
- Clonidine Hydrochloride 0.1 mg (Actavis)
- Clonidine Hydrochloride 0.3 mg (Actavis)
- 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.)
- 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 (Sandoz Pharmaceuticals Inc.)
- Hydrochlorothiazide and Triamterene 25 mg / 37.5 mg (Mylan Pharmaceuticals Inc.)
- Naloxone Hydrochloride and Pentazocine Hydrochloride 0.5 mg / 50 mg (Watson Pharmaceuticals)
- Omeprazole Delayed Release 20 mg (Dr. Reddy’s Laboratories Inc.)
- Oxycodone Hydrochloride 15 mg (Actavis)
- Propranolol Hydrochloride 80 mg (Mylan Pharmaceuticals Inc.)
- Warfarin Sodium 5 mg (Taro Pharmaceuticals U.S.A., Inc.)
