6313. Foley basic urinary antiseptic tablets.    (F.D.C. No. 44589.   S. No. 30-837
R.)
QUANTITY : 792 individually ctnd. btls. at Foley, Ala., in possession of Foley
& Co.
SHIPPED: The article in the bottles was repacked and labeled, as described
below, by the dealer from bulk stock shipped on 11-18-59, from Chicago, 111.
LABEL IN PAST: (Btl.) "144 Tablets Foley Basic Urinary Antiseptic Tablets
Active ingredients: Methenamine 2? gr. Calcium Mandelate 2.7843 gr.
Manufactured for Foley & Company, Chicago, 111. * * * Directions * * *
Read Treatment Leaflet"
ACCOMPANYING LABEL: Leaflets in carton entitled "Getting up Nights . . .
Can you Break the Habit?" and "Foley & Company * * * Dear Customer:."
LIBELED:   5-23-60, S. Dist. Ala.
CHARGE: 502(a)-when shipped and while held for sale, the labeling which
accompanied the article contained false and misleading representations that
the article was an adequate and effective treatment for all conditions such
as backaches, painful passage, frequent urination, and sagging muscles, re-
sulting from bladder infections; and 503(b) (4)-the article was subject to
503(b) (1) and its label failed to bear the statement "Caution: Federal law
prohibits dispensing without prescription.,*
DISPOSITION:   9-1-60.   Consent-Claimed by Foley & Co. and relabeled.
DRUGS AND DEVICES ACTIONABLE BECAUSE OF FAILURE TO BEAR
ADEQUATE DIRECTIONS OR WARNING STATEMENTS*