332. Misbranding of Reed's Effervescent Bromo-Sizz.   TJ. S. v. 83 Display Cartons
of Reed's Effervescent Bromo-Sizz.    Default decree of condemnation and
destruction.    (F. D. C. No. 2329.   Sample No. 16463-E.)
This product contained acetanilid and would be dangerous to health when
used as directed, but was not labeled to show the consequences that might re-
sult from its use. The labeling also failed to comply with the law in certain
other respects as indicated hereinafter.
On July 10, 1940, the United States attorney for the District of Nebraska
filed a libel against 83 display cartons of Reed's Effervescent Bromo-Sizz at
Omaha, Nebr., alleging that the article had been shipped in interstate commerce
on or about May 17, 1940, by the Reed Products Co. from St. Louis, Mo.; and
charging that it was misbranded.
The article was alleged to be misbranded (1) in that it was in package form,
and its label failed to bear a statement of the quantity of the contents; (2) its
label failed to bear a statement of the quantity or proportion of acetanilid that
it contained since the statement "each teaspoonful contains approx. 3 grains
acetanilid" was not informative in view of the directions to "add contents of
this tube in half glass of water"; (3) its label failed to bear a declaration of
the quantity or proportion of sodium bromide present since the statement
"sodium bromide approx. 3?" was not a correct statement of the proportion
of sodium bromide present and was not informative to the purchaser as to
the amount of sodium bromide which would be consumed when the article
was taken in accordance with the directions; (4) the label failed to bear ade-
quate directions for use since the directions were incomplete and were not
appropriate for an article of the composition found; (5) its label failed
to bear adequate warnings against its 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; and (6) 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, namely, "Add contents
of this tube in half glass of water. Repeat in half hour if necessary. No more
than three teaspoonfuls to-" (The words "be taken within 24 hours" which
followed the statements quoted were concealed on the package as purchased
by overlapping of the label.)
On November 25, 1940, no claimant having appeared, judgment of condemna-
tion was entered and the product was ordered destroyed.