80. Misbranding of Cephalgine  Tablets.    U. S. v. 30 Packages of Cephalgine
Tablets.     Default decree  of  condemnation and destruction.     (F.  D.  C
No. 460.    Sample No. 69431-D.)
This product consisted essentially of acetanilid, caffeine, and camphor. It
would be dangerous to health when used as recommended, and its labeling
failed to reveal the consequences which might result from its use. Its labeling
was further objectionable because of false and misleading representations
regarding its efficacy in the conditions indicated hereinafter.
On August 28, 1939, the United States attorney for the District of New
Hampshire filed a libel against 30 packages of Cephalgine Tablets at Concord,
N. H., alleging that the article had been shipped in interstate commerce on or
about March 28 and April 20, 1939, by the Cephalgine Co. from Spencer, Mass.;
and charging that it was misbranded.
It was alleged to be misbranded in that it was dangerous to health when
used in the dosage or with the frequency prescribed, recommended, or sug-
gested in the labeling, which recommended that a dose of one or two tablets
be taken; that two more might be taken in 1 hour if needed or that two
tablets might be taken every 8 or 4 hours and that, between the ages of 5 and
10, half the above dose should be administered; and because of failure of the
labeling to bear 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. It was alleged to be mis-
branded further in that statements in the labeling in which It was recommended
as a relief of pain and discomfort due to simple headaches, neuralgia, and
muscular aches and pains and in which it was represented that frequent use
did not require an increase in the dose; that it contained no habit-forming
drug or narcotic were false and misleading, since it was not a safe remedy
for the conditions mentioned, and the said statements encouraged the user to
take the preparation frequently and misled the user to believe that it might
be taken with safety; whereas it contained a dangerous drug, acetanilid.
On October 18, 1939, no claimant having appeared, judgment of condemnation
was entered and the product was ordered destroyed.