title: Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; amendment of final monograph for OTC antitussive drug products.  Food and Drug Administration, HHS.  Final rule.
abstract: The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph for over-the-counter (OTC) antitussive drug products (products that relieve cough).  Use of topical/inhalant products containing camphor or menthol near a flame, in hot water, or in a microwave oven may cause the products to splatter and cause serious burns to the user.  As part of its ongoing review of OTC drug products, FDA is adding warnings and directions to inform consumers about these improper uses and is amending its final regulations for OTC drug labeling requirements to add this new flammability warning for antitussive drug products containing camphor or menthol.
mesh_terms: D018927:Anti-Asthmatic Agents / Q000009:adverse effects; D000996:Antitussive Agents / Q000009:adverse effects*; D002057:Burns, Chemical / Q000517:prevention & control; D002164:Camphor / Q000009:adverse effects; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence / Q000592:standards; D006801:Humans; D008610:Menthol / Q000009:adverse effects; D004366:Nonprescription Drugs / Q000592:standards; D011356:Product Labeling / Q000331:legislation & jurisprudence / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D018927:Anti-Asthmatic Agents; D000996:Antitussive Agents; D004366:Nonprescription Drugs; D008610:Menthol; D002164:Camphor