434. Misbranding of Happy Day Headache Powders. U. S. v. 21% Gross Packages
of Happy Day Headache Powders. Default decree of condemnation and
destruction.    (F. D. C. No. 4008.    Sample No. 50903-E.)
This product would be dangerous to health when used according to direc-.
tlons, its labeling failed to bear adequate directions for use and warning state-
ments, and in addition it bore false and misleading therapeutic claims.
On or about March 21, 1941, the United States attorney for the Western
District of Virginia filed a libel against 21? gross packages of Happy Day
Headache Powders at Roanoke, Va., alleging that the article had been shipped
from Winston-Salem, N. C, in part in the personally owned automobile of
Max Caplan, owner of the Capital Drug Co., Roanoke, Va., on or about Septem-
ber 16, 1940, and in part by the Sessions Specialty Co. on or about November 8,
1940; and charging that it was misbranded. It was labeled in part: "Happy
Day Headache Powders * * * Manufactured by Gulf Laboratories Inc.
Lafayette Louisiana."
Analyses of samples of the article showed that it consisted essentially of
acetanilid (2? grains per powder), aspirin, caffeine, phenolphthalein, and
milk sugar.
The article was alleged to be misbranded: (1) In that it would be dangerous
to health when used in the dosage or with1 the frequency or duration prescribed,
recommended, or suggested in the labeling, namely, (envelope containing pow-
der) "Directions Take one powder dry on the tongue followed with water, or
mixed with a little water. One powder usually gives the desired results. If
necessary, another powder may be taken in 30 minutes. Women will find this
especially beneficial during painful menstrual periods"; (circular) "Take one
powder dry on the tongue, followed by a swallow of water, or mix well with
small quantity of water and take. Repeat in 20 minutes if necessary. One
powder usually gives relief. Children over 6 years: ? to y2 of one powder.
* * * One powder well mixed in a little water at the first sign of cold or
fever and one two hours later. One powder at night just before retiring is
recommended. Children over six years: y2 powder mixed in water 3 times daily
according to age. * * * One powder dissolved in water every 2 or 3 hours as
required." (2) In that th'e labeling failed to bear adequate directions for use.
(3) In that the labeling did not bear such adequate 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. (4) In that statements in the labeling representing that it would be
efficacious for the relief of discomfort arising from head colds, hay fever, and
nervousness; that it would reduce fever, insuring speedy relief; that it would
be efficacious for the relief of pains caused by menstrual disturbances, tonsillitis,
headache caused by sinus trouhle, rheumatism, influenza, and throat irritations,
were false and misleading since it would not be efficacious for such purposes.
(5) In that the label did not bear the common or usual names of the active
ingredients. (6) In that the label did not bear an accurate statement of the
quantity of contents.
On July 15, 1941, no claimant having appeared, judgment of condemnation
was entered and the product was ordered destroyed.