FD&C Red No. 3
Excipient (pharmacologically inactive substance)
What is it?
FDA has regulatory oversight for color additives used in foods, drugs, cosmetics, and medical devices. FD&C Red No. 3, also known as erythrosine, is a synthetic dye with a cherry-pink stain. In foods it is used to dye cake decorating gel, candies and popsicles, among other food items. Red #40 (Allura Red), is an azo dye, but it is often used in place of Red Dye #3 and can still be found in use in the food industry. Red Dye #3 is also used as color additive for ingested drugs. It is not listed as approved for use in cosmetics.[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#21:1.0.1.1.27.1.31.6
[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 with this excipient
- Acetaminophen and Diphenhydramine Hydrochloride 500 mg / 25 mg (Target)
- Atomoxetine Hydrochloride 80 mg (Sandoz Pharmaceuticals Inc.)
- Carbamazepine Extended-Release 200 mg (Prasco Laboratories)
- Dilantin 30 mg (Pfizer U.S. Pharmaceuticals Group)
- Fluoxetine Hydrochloride and Olanzapine 50 mg / 12 mg (Par Pharmaceutical)
- Fluoxetine Hydrochloride and Olanzapine 50 mg / 12 mg (Sandoz Inc.)
- Indomethacin 50 mg (Heritage Pharmaceuticals, Inc.)
- Indomethacin 25 mg (Heritage Pharmaceuticals, Inc.)
- Mefenamic Acid 250 mg (United Research Laboratories/Mutual Pharmaceutical Company)
- Minipress 1 mg (Pfizer U.S. Pharmaceuticals Group)
- Mycophenolate Mofetil 250 mg (Strides Arcolab Limited)
- Norpace 100 mg (Searle)
- Phentermine Hydrochloride 15 mg (Sandoz Pharmaceuticals Inc.)
- Phentermine Hydrochloride 15 mg (TAGI Pharma, Inc.)
- Ramipril 5 mg (Apotex Corp.)
- Ramipril 2.5 mg (Apotex Corp.)
- Tacrolimus 1 mg (Mylan Pharmaceuticals Inc.)
- Vyvanse 20 mg (Shire US Inc.)
- Vyvanse 40 mg (Shire US Inc.)
- Vyvanse 30 mg (Shire US Inc.)
