FD&C Yellow No. 6 Aluminum Lake
Excipient (pharmacologically inactive substance)
What is FD&C Yellow No. 6 Aluminum Lake?
FD&C Yellow No. 6 Aluminum 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 Aluminum 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 Aluminum 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. 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 Yellow No. 6 Aluminum Lake
- Alprazolam 0.5 mg (Actavis)
- Alprazolam 0.5 mg (Sandoz Pharmaceuticals Inc.)
- Alprazolam Extended Release 2 mg (Actavis)
- Bisoprolol Fumarate and Hydrochlorothiazide 5 mg / 6.25 mg (Mylan Pharmaceuticals Inc.)
- Bisoprolol Fumarate and Hydrochlorothiazide 2.5 mg / 6.25 mg (Mylan Pharmaceuticals Inc.)
- Cefprozil 250 mg (Lupin Pharmaceuticals, Inc)
- Cimetidine 400 mg (Mylan Pharmaceuticals Inc.)
- Clonidine Hydrochloride 0.1 mg (Actavis)
- Clonidine Hydrochloride 0.3 mg (Actavis)
- CLORAZEPATE DIPOTASSIUM 7.5 MG (Ranbaxy Pharmaceuticals Inc.)
- Doxepin Hydrochloride 25 mg (Mylan Pharmaceuticals Inc.)
- Doxepin Hydrochloride 50 mg (Mylan Pharmaceuticals Inc.)
- Doxepin Hydrochloride 10 mg (Mylan Pharmaceuticals Inc.)
- Famotidine 20 mg (Mylan Pharmaceuticals Inc.)
- Flexeril 5 mg (McNeil Consumer)
- Isosorbide Dinitrate 20 mg (Sandoz Pharmaceuticals Inc.)
- Naloxone Hydrochloride and Pentazocine Hydrochloride 0.5 mg / 50 mg (Watson Pharmaceuticals)
- Propranolol Hydrochloride 10 mg (Mylan Pharmaceuticals Inc.)
- Propranolol Hydrochloride 80 mg (Mylan Pharmaceuticals Inc.)
- Propranolol Hydrochloride 40 mg (Mylan Pharmaceuticals Inc.)
