title: Pharmaceutical excipients and the information on drug labels.
abstract: OBJECTIVE
  to evaluate the presence of preservatives, dyes, sweeteners and flavouring substances in 73 pharmaceutical preparations of 35 medicines for oral administration, according to drug labeling information about the excipients.
  
  
  METHODS
  35 medications were selected, both over-the-counter and prescription drugs, marketed in Brazil. The sample included: analgesic/antipyretic, antimicrobial, mucoregulatory, cough and cold, decongestant, antihistamine, bronchodilator, corticosteroid, antiinflammatory and vitamin medications. We collected data on 73 preparations of these drugs, according to drug labeling information regarding preservatives, dyes, sweeteners and flavourings.
  
  
  RESULTS
  Methylparaben and propylparaben were the most common preservatives found (43% and 35.6% respectively). The most common sweeteners were: sucrose (sugar) (53.4%), sodium saccharin (38.3%) and sorbitol (36.9%). Twenty-one medicines (28,7%) contained two sweeteners. Colourless medicines predominated (43.8%), followed by those with sunset yellow dye (FD&C yellow no. 6) (15%). Five products (6.8%) contained more than one colour agent. Tartrazine (FD&C yellow no. 5) was present in seven preparations (9.5%). Fruit was the most common flavouring found (83%). Labelings of drugs which contained sugar frequently omitted its exact concentration (77%). Of the four labelings of medicines which contained aspartame, two did not warn patients regarding phenylketonuria.
  
  
  CONCLUSIONS
  Omission and inaccuracy of drug labeling information on pharmaceutical excipients may expose susceptible individuals to adverse reactions caused by preservatives and dyes. Complications of inadvertent intake of sugar-containing medicines by diabetics, or aspartame intake by patients with phenylketonuria may also occur.
authors.affiliation: University Hospital, Medical School of Botucatu, UNESP, Department of Otorhinolaryngology, SP, Brazil. a_balbani@hotmail.com
authors.forename: Aracy Pereira Silveira
authors.initials: AP
authors.lastname: Balbani
authors.forename: Lucilena Bardella
authors.initials: LB
authors.lastname: Stelzer
authors.forename: Jair Cortez
authors.initials: JC
authors.lastname: Montovani
mesh_terms: D004396:Coloring Agents / Q000032:analysis; D004348:Drug Labeling / Q000592:standards*; D005421:Flavoring Agents / Q000032:analysis; D006801:Humans; D010592:Pharmaceutic Aids / Q000032:analysis*; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D011310:Preservatives, Pharmaceutical / Q000032:analysis; D013549:Sweetening Agents / Q000032:analysis
chemical_list: D004396:Coloring Agents; D005421:Flavoring Agents; D010592:Pharmaceutic Aids; D004364:Pharmaceutical Preparations; D011310:Preservatives, Pharmaceutical; D013549:Sweetening Agents