755. Adulteration and misbranding of Gilmore's Headache Powders,    TJ. S. v. 45
Packages of Gilmore's Headache Powders.    Default decree of condemna,-
tion and destruction.    (F. D. C. No. 7354.    Sample No. 86370-E.)
This product, in addition to being dangerous to health when used according
to directions, failed to bear adequate directions for use and warning statements
in the labeling, and contained acetanilid, caffeine citrate, and sodium bicar-
bonate greatly in excess of the amounts declared on the label.
On April 16, 1942, the United States attorney for the Northern District of
Indiana filed a libel against 45 packages of the above-named article at Fort
Wayne, Ind., alleging that it had been shipped in interstate commerce on or
about November 11 and December 9, 1941, by the Don Gilmore Laboratories,
Inc., from Cleveland, Ohio; and charging that it was adulterated and mis-
branded. The article was labeled in part: "Each Powder contains 2? grains
Acetanilid   *   *   *    ? grain Caffeine Citrate, ? grain Sodium Bicarbonate."
Analysis of a sample of the article showed that each powder contained 6.93
grains of acetanilid, 2.61 grains of caffeine citrate, and 2.50 grains of sodium
bicarbonate.
It was alleged to be adulterated in that its strength differed from that which
it. purported or was represented to possess.
It was alleged to be misbranded: (1) In that it would be dangerous to
health when used in the dosage or with the frequency or duration prescribed,
recommended, or suggested in the labeling, namely, "Directions: Place a pow-
der on the tongue and swallow with water. Repeat in twenty minutes if
necessary," since when taken in accordance with these directions the powders
would provide for the administration of slightly less than 14 grains of ace-
tanilid in 20 minutes. (2) In that the labeling failed to bear adequate warn-
ings 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, in such manner and form as are necessary for the protec-
tion of users, since the powders contained acetanilid and the labeling con-
tained no warning that frequent or continued use might be dangerous, causing
serious blood disturbances, anemia, collapse, or dependence on the drug; and,
further, that the powders, should not be given to children. (3) In that the
label failed to bear adequate directions for use. (4) In that the statement on
the label, "Each Powder contains 2y2 grains Acetanilid * * * ? grain
Caffeine Citrate, ? grain Sodium Bicarbonate," was false and misleading.
On July 1, 1942, no claimant having appeared, judgment of condemnation
was entered and the product was ordered destroyed.
DRUGS  ACTIONABLE  BECAUSE  OF  FAILURE  TO   BEAR ADEQUATE
DIRECTIONS OR WARNING STATEMENTS3