FD&C Yellow No. 6
Excipient (pharmacologically inactive substance)
What is FD&C Yellow No. 6?
FDA has regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. FD&C Yellow No. 6 (also known as sunset yellow) is a colorant used in drug dosage forms such as tablets and capsules. It is also approved for use in foods and cosmetics. FD&C Yellow No. 6, a water-soluble, monoazo dye, imparts a reddish-yellow color to medicinal dosage forms. Animals studies have not reported a carcinogenic (cancer-causing) potential for FD&C Yellow No. 6.[1] [2]
[1] Huff J.Environ. Health Perspect. FD&C Yellow No. 6. 1982.45:209-10. Accessed 10/20/2011. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1569019/?page=2
[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
- Acetaminophen and Hydrocodone Bitartrate 325 mg / 7.5 mg (Qualitest Pharmaceuticals Inc.)
- Acetaminophen and Hydrocodone Bitartrate 325 mg / 5 mg (Qualitest Pharmaceuticals Inc.)
- Alprazolam 0.5 mg (Greenstone Limited)
- Alprazolam 0.5 mg (Qualitest Pharmaceuticals Inc.)
- Amitriptyline Hydrochloride 25 mg (Mylan Pharmaceuticals Inc.)
- Amphetamine and Dextroamphetamine 20 mg (Teva Pharmaceuticals USA)
- Amphetamine and Dextroamphetamine 30 mg (Teva Pharmaceuticals USA)
- Amphetamine and Dextroamphetamine 20 mg (Sandoz Pharmaceuticals Inc.)
- Cyclobenzaprine Hydrochloride 10 mg (Qualitest Pharmaceuticals Inc.)
- Cyclobenzaprine Hydrochloride 10 mg (Teva Pharmaceuticals)
- Cyclobenzaprine Hydrochloride 10 mg (Amneal Pharmaceuticals)
- Diazepam 5 mg (Mylan Pharmaceuticals Inc.)
- Endocet 325 mg / 7.5 mg (Endo Pharmaceuticals Inc.)
- Hydrochlorothiazide 25 mg (Qualitest Pharmaceuticals Inc.)
- Hydrochlorothiazide 25 mg (IVAX Pharmaceuticals Inc.)
- HydrOXYzine Pamoate 25 mg (Sandoz Pharmaceuticals Inc.)
- Hydroxyzine Pamoate 25 mg (Teva Pharmaceuticals USA)
- Morphine Sulfate SR 60 mg (Mallinckrodt Pharmaceuticals)
- Suboxone 8 mg / 2 mg (Reckitt Benckiser Pharmaceuticals, Inc.)
- Zolpidem Tartrate 10 mg (Mylan Pharmaceuticals Inc.)


