|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
January 20, 1999
a) Extendryl SR Extended-Release Capsules (chlorpheniramine maleate 8mg/phenylephrine HCL
20 mg/methscopolamine nitrate 2.5mg), in 100 capsules. NDC #0256-0111-01; b) Extendryl JR
Extended-Release Capsules (chlorpheniramine maleate 5mg/phenylephrine HCL 10
mg/methscopolamine nitrate 1.25 mg), in 100 capsule bottles. NDC #0256-0177-01. Both
products are Rx for the relief of respiratory congestion, allergic rhinitis, vasomotor
rhinitis, and allergic skin reactions of urticaria and angioedema. Recall #D-091/092-9.
Lot numbers: 8083633, 8091637, 8092634, 8091636.
Fleming and Company, Fenton, Missouri.
Manufacturer, by telephone the latter part of the week of November 30, 1998, followed by
letter on or about December 1, 1998. Firm-initiated field correction ongoing.
6,418 units were distributed.
Mislabeling - Inserts are incorrectly printed with both sides the same.