FD&C Red No. 3
Medically reviewed by Drugs.com. Last updated on Mar 28, 2024.
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]
List of medications using FD&C Red No. 3
- Acetaminophen and Diphenhydramine Hydrochloride 500 mg / 25 mg
- Acetaminophen and Hydrocodone Bitartrate 500 mg / 2.5 mg
- Acetaminophen, Butalbital, Caffeine and Codeine Phosphate 325mg / 50mg / 40mg / 30mg
- Dexmethylphenidate Hydrochloride Extended-Release 5 mg
- Doxycycline Monohydrate 100 mg
- Esomeprazole Magnesium Delayed-Release 20 mg
- Fluoxetine Hydrochloride 20 mg
- Fluoxetine Hydrochloride 40 mg
- Fluoxetine Hydrochloride 10 mg
- Gabapentin 300 mg
- Omeprazole Delayed-Release 40 mg
- Omeprazole Delayed-Release 40 mg
- Phentermine Hydrochloride 15 mg
- Phentermine Hydrochloride 30 mg
- Phentermine Hydrochloride 30 mg
- Phentermine Hydrochloride 15 mg
- Phentermine Hydrochloride 37.5 mg
- Phenytoin Sodium Extended 100 mg
- Potassium Chloride Extended-Release 10 mEq (750 mg)
- Vyvanse 10 mg
References
- 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
- 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
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
