Class of excipients | Excipient | Frequency of use (n = 67) | Concentration in leaflet | Score ratea | ADI | Compliance status |
---|---|---|---|---|---|---|
Coloring agents/dyes | Tartrazine | 1 | Not stated | 0/1 | 25 mg/kg | Cannot be determined |
Sunset yellow | 8 | Not stated | 0/8 | 0.3 mg/kg | Cannot be determined | |
Preservatives | Methylparaben Proplyparaben | 11 (As parabens) | 0.045–0.18% 0.011–0.02% | 3/11 | 5 mg/kg | Appropriate |
Sodium Benzoate | 10 | 0.8% w/v | 2/10 | 10 mg/kg | Appropriate | |
Solvents/co-solvents | Ethanol | 42 | 1–90% v/v | 26/42 | 5 g/day | Inappropriate |
Propylene Glycol | 7 | Not stated | 0/7 | 10 mg/kg | Cannot be determined | |
Surfactants | Polysorbate 80 | 2 | Not stated | 0/2 | 10 mg/kg | Cannot be determined |
Sweetners | Aspartame | 2 | 0.03 g/5 ml | 2/2 | < 10 mg/kg | Appropriate |
Saccharin Sodium | 6 | 5 mg/5 ml | 1/6 | 2.5 mg/kg | Too high for infants | |
Sorbitol | 8 | 1 g–1.06 g/5 ml | 2/8 | 0.3 mg/kg | Too high for infants and neonates | |
Sucrose | 11 | 1.7 g–3.7 g/5 ml | 5/11 | < 25 g/day | Too high for infants and neonates when added to sugar from foods |