430. Misbranding of Bromo-Thein. IT. S. v. 48 Bottles of Bromo-Thein. Default
decree of condemnation and destruction. (F. D. C. No. 3943. Sample No.
31586-E.)
This product consisted essentially of acetanilid, bromides (such as sodium bro-
mide and potassium bromide), aspirin, caffeine, sodium bicarbonate, citric acid,
and tartaric acid.   It would be dangerous to health when used as recommended?/
and its labeling failed to reveal the consequences which might result from its?-
use and failed in other respects as indicated hereinafter to comply with the
labeling requirements of the law.
On March 10, 1941, the United States attorney for the Eastern District of?(
Michigan filed a libel against 48 bottles of Bromo-Thein at Detroit, Mich.,
alleging that the article had been shipped in interstate commerce on or about
February 8, 1941, by Lockwood Laboratories from Hammond, Ind.; and charging
that it was misbranded.
The article was alleged to be misbranded in that the statement of active
ingredients, the directions for use, and the warning appearing upon the label
were not prominently placed thereon with such conspicuousness as to render
them likely to be read and understood by the ordinary individual under customary
conditions of purchase and use, since the statement "Chester A, Lockwood"
diagonally written across these, statements tended to obscure them.
It was alleged to be misbranded further in that the label failed to bear adequate
directions for use, since they did not provide for a limit as to duration or
frequency of administration.
It was alleged to be misbranded further in that the label failed to bear
adequate warnings against use in those pathological conditions where its use
might be dangerous to health, or against unsafe dosage or methods or duration
of administration, in such manner and form, as were necessary for the pro-
tection of users, since there was no warning that the frequent or continued
use of acetanilid might be dangerous, causing serious blood disturbances, anemia,
collapse, or a dependence on the drug, and that frequent or continued use of
bromides might lead to mental derangement, skin eruptions, or other serious
effects. (The preparation, when taken according to directions, would permit
the administration of 6.84 grains of acetanilid daily,)
The article was alleged to be misbranded further in that it was dangerous
to health when used in the dosage, or with the frequency or duration prescribed,
recommended, or suggested in the labeling thereof, namely: "Dose: a heaping
teaspoonful in half glass of water; if not relieved repeat after interval of four
hours, not to exceed three doses in twenty-four hours."
On April 3, 1941, no claimant having appeared, judgment of condemnation
was entered and the product was ordered destroyed.