Dr. Merikangas stated incorrectly in his letter that Anusol Suppositories used to contain bismuth subgallate, bismuth resorcinol, and pramoxine HCl in a zinc oxide base and coconut oil. Pramoxine hydrochloride and coconut oil were never present in our domestic suppository formulation.

I would like to comment on his first statement: "There is a new hazard in over-the-counter medication". Anusol suppositories and ointment are marketed under the Final Monograph for Anorectal Drug Products, which was published in the Federal Register on 3 August 1990. This regulation established the conditions under which over-the-counter anorectal drug products are recognized as "safe" and "effective" and not misbranded. The active ingredients present in our Anusol Suppositories, phenylephrine HCl and witepsol, were reviewed by the Food and Drug Administration and found to be "safe" and "effective" when used according to the labeling directions.

In addition to conforming to federal regulations, this Warner-Lambert drug product also complies with a National Drug Manufacturers Association voluntary guideline that was established to help the consumers use over-the-counter drug products safely and correctly. In the case of Anusol Suppositories, when they were reformulated to contain different active ingredients, the principal display panel of the folding carton was flagged appropriately to alert the consumers of the change, and the back of the carton was revised to comply with the label readability guideline.

I believe that the Warner-Lambert Company has taken the appropriate measures to alert and inform consumers. It has also made provision for questions. Consumers can call our medical department using the toll free number listed on the label.