904. Misbranding of Trems.    U. S. v. 40 Packages of Trems.    Default decree of
condemnation and destruction.     (F. D. C. No. 10171.    Sample No. 32531-F.)
This product consisted of tablets, each containing essentially 1 grain of pheno-
barbital, 3 grains of aspirin and ? grain of caffeine.
On July 7, 1943, the United States attorney for the Northern District of Ohio
filed a libel against 40 packages of Trems at Cleveland, Ohio, alleging that the
article had been shipped in interstate commerce by Trems, Inc., from St. Louis,
Mo.; and charging that it was misbranded.
The article was alleged to be misbranded (1) in that it was dangerous to
health when used in the dosage and with the frequency and duration prescribed,
recommended, and suggested in the labeling, "Dosage: Sleeplessness-For Adults,
Two tablets 20 minutes before retiring. Other symptons-One or two tablets as
required," since it contained phenobarbital, a drug which cannot be administered
with safety except under competent supervision, and the directions which ap-
peared in the labeling did not provide for any limitation in the dosage, but
Implied that it might be taken as frequently as desired with safety; (2) in that
it was for use by man and contained a chemical derivative of barbituric acid,
phenobarbital, which derivative has been found by the Federal Security Ad-
ministrator, after investigation, to be, and by regulations designated as, habit-
forming, and (a) its label failed to bear the statement: "Warning-May be habit
forming" in juxtaposition with the name and quantity or proportion of such
derivative of barbituric acid, and (b) its label failed to bear, as such regulations
specify, the name and quantity or proportion of phenobarbital and the statement:
"Warning-May be habit forming," immediately following, without intervening
written, printed, or graphic matter, the name by which such drug was titled.
On August 17, 1943, no claimant having appeared, judgment of condemnation
was entered and the product was ordered destroyed.