604. Misbranding of Dr. Hand's Worm Elixir. TJ. S. v. 23% Dozen Bottles of
Dr.   Hand's   Worm   Elixir.     Decree   of   condemnation   and   destruction.
(F. D. C. No. 7137.   Sample No. 31378-E.)
On April 1,1942, the United States attorney for the Eastern District of Michi-
gan filed a libel against 23? dozen bottles of Dr. Hand's Worm Elixir at Detroit,
Mich., alleging that the article had been shipped in interstate commerce by
Smith, Kline & French Laboratories from Philadelphia, Pa., on or about February
17,1942.
Analysis of a sample of the article showed that it consisted essentially of
extracts of plant drugs, including santonin and a laxative drug, in a vehicle
of syrup, a small proportion of alcohol, and flavoring material. Santonin was
present in solution to the extent of 0.164 gram per 100 cubic centimeters and in
the sediment to the extent of 0.065 gram per 100 cubic centimeters.
The article was alleged to be misbranded in that it was dangerous to health
when used in the dosage and with the frequency or duration prescribed in the
labeling, since the amount of santonin provided by the article when used in ac-
cordance with such directions was sufficient to produce serious poisoning. The
dosage recommended was as follows: "DOSE-2 to 4 years, 1 teaspoonful; 4 to
6 years, 1? to 2 teaspoonfuls; 6 to 10 years, 2 to 3 teaspoonfuls~; adults, 4 tea-
spoonfuls. Give first, dose at bedtime, second dose the first thing the following
morning and third dose two hours later. Give a light diet while using the
medicine. Do not repeat treatment for seven days. If the bowels have not
moved freely within two hours after the third dose, give an enema or a quick
acting cathartic, such as Epsom salt or citrate of magnesia until free move-
ment has occurred.   Do not give an oily cathartic."
On August 7, 1942, judgment of condemnation was entered and the product
was ordered destroyed.
DRUGS ACTIONABLE  BECAUSE  OF  FAILURE TO  BEAR ADEQUATE
DIRECTIONS OR WARNING STATEMENTS1