672. Adulteration and misbranding of Zerbst's Capsules.    TJ. S. v. 84 Dozen Pack
ages of Zerbst's Capsules.    Default decree of destruction.     (P. D. C. No.
6572.    Sample No. 73122-E.)
This product contained acetanilid, aloin, and a resin such as podophyllin. In
addition to failure to bear adequate directions and warnings on the label, it
contained approximately 20 percent more acetanilid than the amount stated on
the label.
On December 24, 1941, the United States attorney for the Western District of
Missouri filed a libel against 94 dozen packages of Zerbst's Capsules at Kansas
City, Mo., alleging that the article had been shipped on or about November 15,
1941, by J. Walker Burns & Co. from Chicago, 111.; and charging that it was
adulterated and' mi^bra-nded.
The article was alleged to be adulterated in that its strength differed from
that which it purported or was represented to possess, namely, (label) "Bach
Capsule contains as active ingredients, Acetanilid 1 Grain," since it contained
materially more than 1 grain of acetanilid.
It was alleged to be misbranded: (1) In that the directions for use, "Adults-
To allay the discomfort in breaking up a common head cold, simple headache or
neuralgia, take one capsule every half hour until three are taken, then one
capsule in two or three hours until three more capsules are taken. Children-
12 years old, one capsule, repeated in three hours," were inappropriate for an
article of its composition and were therefore inadequate. (2) In that the label
failed to bear adequate warnings against its use by children or in those pathologi-
cal conditions where its use might be dangerous to health and against unsafe
dosage or duration of administration, in such manner and form as are necessary
for the protection of users, since there was no warning against its use by chil-
dren, against use in the presence of the symptoms of appendicitis, nor with refer-
ence to the deleterious effects of acetanilid in causing serious blood disturbances,
or that frequent or continued use might result in dependence upon the drug.
On February 13, 1942, no claimant having appeared, judgment was entered
ordering that the product be destroyed.
DRUGS  ACTIONABLE  BECAUSE OF FAILURE TO COMPLJ WITH
OFFICIAL OR OWN STANDARDS!