"Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics Committee on Drugs.
Because of an increasing number of reports of adverse reactions associated with pharmaceutical excipients, in 1985 the Committee on Drugs issued a position statement recommending that the Food and Drug Administration mandate labeling of over-the-counter and prescription formulations to include a qualitative list of inactive ingredients. However, labeling of inactive ingredients remains voluntary. Adverse reactions continue to be reported, although some are no longer considered clinically significant, and other new reactions have emerged. The original statement, therefore, has been updated and its information expanded.
D000293:Adolescent; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000737:chemistry; D001218:Aspartame / Q000009:adverse effects; D001548:Benzalkonium Compounds / Q000009:adverse effects; D019905:Benzyl Alcohol; D001592:Benzyl Alcohols / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004396:Coloring Agents / Q000009:adverse effects; D004348:Drug Labeling; D005079:Excipients / Q000009:adverse effects*; D005503:Food Additives / Q000009:adverse effects*; D006801:Humans; D007785:Lactose / Q000009:adverse effects; D009330:Nebulizers and Vaporizers; D014677:Pharmaceutical Vehicles / Q000009:adverse effects; D019946:Propylene Glycol; D011409:Propylene Glycols / Q000009:adverse effects; D012439:Saccharin / Q000009:adverse effects; D013447:Sulfites / Q000009:adverse effects
D018927:Anti-Asthmatic Agents; D001548:Benzalkonium Compounds; D001592:Benzyl Alcohols; D004396:Coloring Agents; D005079:Excipients; D005503:Food Additives; D014677:Pharmaceutical Vehicles; D011409:Propylene Glycols; D013447:Sulfites; D019946:Propylene Glycol; D012439:Saccharin; D007785:Lactose; D019905:Benzyl Alcohol; D001218:Aspartame