i>47. Misbranding- of Special Formula Tablets and McNeal's Laxative Gold Tablets.
V. S. v. 88,020 Tablets in containers labeled "Special Formula Tablets-
Mono. 'L.'" and 41 Dozen Boxes of similar tablets labeled _ "McNeal's
Laxative Cold Tablets." Consent decree of condemnation. Product ordered
released under bond to be relabeled. (F. D. C. No. 4037. Sample Nos.
2S397-E, 28398-E.)
These tablets were of identical composition. Those in boxes labeled "McNeal's
Laxative Cold Tablets" would have been dangerous to health when used according
to directions on the label; they also contained false and misleading therapeutic
claims. These tablets and the loose ones in the large container failed to bear
adequate directions for use and adequate warning statements. The label for the
loose tablets also failed to bear the required ingredient statement.
On March 24,1941, the United States attorney for the District of Maryland filed
a libel against the above-named product at Baltimore, Md., alleging that it had
been shipped from Buffalo, N. Y., on or about December 16, 1940, by Arner Co.,
Inc.; and charging that it was misbranded.
Analysis of a sample of the article showed that each tablet contained acetahilid
(approximately 1 grain), quinine sulfate (approximately 0.38 grain), a laxative
plant drug, and a small amount of atropine.
McNeal's Laxative Cold Tablets were alleged to be misbranded in that they
would have been dangerous to health when used in the dosage or with the fre-
quency or duration prescribed, recommended, or suggested in the labeling, "Direc-
tions ;-Usual dose. 2 tablets just after meals & at bedtime. Delicate persons
may take 1. When relieved take half dose for day or two. Children over 10,
y2 adult dose. Limit 4 doses-24 hrs." They were allfged to be misbranded
further in that the following statements appearing on the label were false and
misleading, "Laxative Cold Tablets Relief for Common Colds * * * A Prepara-
tion for Colds * * * The 2nd or 3rd dose should relieve the Cold '* * *
partly as a result of bowel movement which should occur in 10 hours after taking,"
since they represented that the article would be efficacious for the purposes recom-
mended ; whereas it would not be efficacious for such purposes. The product in
both types of containers was alleged to be misbranded in that the labeling did
not bear adequate directions for use, and in that the labeling did not bear such
adequate warnings against use in those pathological conditions or by children
where its use might be dangerous to health, or against unsafe dosage or methods
or duration of administration or application, in such manner and form as are
necessary for the protection of users. The Special Formula Tablets were alleged
to be misbranded further in that the label did not bear the common or usual
names of the active ingredients or a statement of the quantities or proportions of
acetanilid and atropine contained therein.
On May 12, 1941, Kent Drug Co., claimant, having consented to the entry of a
decree, judgment of condemnation was entered and the product was ordered
released under bond conditioned that it be relabeled under the supervision of the
Federal Security Agency (Food and Drug Administration).