Is Amoxicillin Free of FD&C Red 40 Dye?
No, amoxicillin oral suspension formulations commonly contain FD&C Red #40 dye as an inactive ingredient. According to FDA labeling, the oral suspension specifically lists "FD&C Red #40 and FD&C Yellow #6" among its inactive ingredients 1.
Formulation-Specific Information
The presence of FD&C Red #40 varies by formulation:
Oral suspension (125 mg/5 mL and 250 mg/5 mL): Contains FD&C Red #40 and FD&C Yellow #6 as coloring agents, along with artificial cream flavor, sucrose, and other inactive ingredients 1
Other formulations: Capsules and tablets may have different inactive ingredient profiles, though the FDA label primarily details the suspension formulation
Historical context: A 1991 study examining 91 antimicrobial preparations found that Red dye #40 was present in 45% of pediatric antimicrobial formulations, making it one of the most commonly used dyes in these medications 2
Clinical Implications
If you need a dye-free amoxicillin formulation, you must specifically request alternatives:
- Contact the manufacturer or pharmacy to identify dye-free formulations
- Consider capsule or tablet forms if the patient can swallow them, as these may have different dye profiles
- Request compounded formulations without artificial dyes if commercially available options all contain FD&C Red #40
Important Caveats
The presence of FD&C Red #40 matters for patients with:
- Known hypersensitivity to azo dyes
- Concerns about synthetic food dye exposure (particularly relevant given emerging research on Allura Red AC's potential health impacts 3)
- Religious or dietary restrictions regarding certain additives
Always verify the specific product's ingredient list with the dispensing pharmacy, as formulations can vary by manufacturer and may change over time. The inactive ingredients listed in FDA labeling represent specific formulations but may not apply universally to all amoxicillin products on the market.