3222. Misbranding of Special tablets and Oxylin antiseptic tablets.    IT. S. v.
5,000 Tablets, etc.    (F. D. C. No. 29314.   Sample No. 81007-K.)
LIBEL FILED :    May
' 12, 1950, Eastern District of Pennsylvania.
ALLEGED SHIPMENT : On or about February 12, 1950, by D. M. Olmstead Labora-
tories, from Camden, N. J.
PBODTJCT : 5,000 Special tablets in bulk, and 19 100-tablet bottles, 9 200-tablet
bottles, 6 500-tablet bottles, and 7 1,000-tablet bottles of Oxylin antiseptic
tablets, at Upper Darby, Pa.
RESULTS OF INVESTIGATION : The tablets contained in tbe bottles were found to
have been repacked by Meredith L. Evons, Upper Darby, Pa., from the bulk
shipment mentioned above.
LABEL, IN PAET : (Bulk shipment) "Special Tablets * * * Each Tablet con-
tains : Oxyquinoline sulfate 1.67 grs. Saccharine ^4 gr. Oil Peppermint Oil
Wintergtfeen Boric Acid q. s. 7.5 grs. C # 20650"; (repackaged tablets)
"Oxylin Antiseptic Tablets * * * Each tablet contains 1.67 grains of oxy-
quinoline sulfate (chinosol), also saccharine, winter green and peppermint.
* * * Internal Uses:-Oxylin Tablets are a valuable intestinal and urinary
antiseptic, inhibit bacteria, arrest fermentation and allay irritation. Pre-
scribed internally wherever intestinal or urinary antisepsis is desired. Indi-
cated conditions are hyperacidity, intestinal toxemia, diarrhea, amebic and
bacillary dysentery, bed wetting, gonorrhea (in solution for irrigation and
orally), nephritis, pyelitis, cystitis, pyuria. Lauded as a specific for intestinal
grippe, influenza and common cold. Dosage-Adults 3 tablets swallowed with
water on an empty stomach, 3 or 4 times daily. In acute or stubborn cases, in-
crease dosage to three tablets every two hours. Children, one tablet, four times
daily, may be dissolved in water.   Do not chew the tablets."
NATURE OF CHARGE: Misbranding (tablets in bulk), Section 502 (f) (1), the
labeling of the article failed to bear adequate directions for use. The article
was misbranded in such respect when introduced into, and while in, interstate
commerce.
Misbranding (tablets in bottles), Section 502 (a), the label of the article
contained statements which represented and suggested that the article was
useful for intestinal or urinary antisepsis, and to arrest fermentation and allay
irritation, and was an adequate treatment for hyperacidity, intestinal toxemia,
diarrhea, amebic and bacillary dystentery, bed wetting, gonorrhea, nephritis,
pyelitis, cystitis, pyuria, intestinal grippe, influenza, and the common cold,
which statements were false and misleading since the article was not useful
nor an adequate treatment for the conditions stated and implied; Section 502
(e) (2), the article was fabricated from two or more ingredients, and its
label failed to bear the common or usual name of the active ingredient, boric
acid; and, Section 502 (j), the article was dangerous to health when used in
the dosage and with the frequency and duration prescribed, recommended, and
suggested in its labeling. The article in the bottles was misbranded in the
respects indicated while held for sale after shipment in interstate commerce.
DISPOSITION :   June 20, 1950.   Default decree of condemnation and destruction.
DRUGS AND DEVICES ACTIONABLE BECAUSE OF FAILURE TO BEAR
ADEQUATE DIRECTIONS OR WARNING STATEMENTS*