FOOD AND DRUG ADMINISTRATION
NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD, DRUG,
AND COSMETIC ACT
[Given pursuant to section 705 of the Food, Drug, and Cosmetic Act]
951-1000
DRUGS AND DEVICES
The cases reported herewith were instituted in the United States district
courts by the United States attorneys acting upon reports submitted by direction
of the Federal Security Administrator.
WATSON B. MILLER, Acting Administrator, Federal Security Agency.
WASHINGTON, D. C, August 21,1944.
CONTENTS*
Page
Drugs actionable because of potential danger
when used according to directions 161
Drugs actionable because of failure to  bear
adequate directions or warning statements.. 162
Drugs actionable because of contamination with
filth 
 166
Drugs actionable because of deviation from
official or own standards 
167
Page
Drugs actionable because of false and misleading
claims 
  175
Human use . 
175
Veterinary use  
 183
Drugs actionable because of failure to bear ac-
curate statements of quantity of contents.. 184
DRUGS ACTIONABLE BECAUSE OF POTENTIAL DANGER WHEN USED
ACCORDING TO DIRECTIONS
951. Misbranding of Improved Cold Tablets.    U. S. v. 126 Packages of Improved
Cold Tablets.    Default decree of condemnation and destruction.    (F. D. C.
No. 8936.   Sample No. 26201-F.)
On December 2, 1942, the United States attorney for the Northern District
of Indiana filed a libel against 126 packages of Improved Cold Tablets at Fort
Wayne, Ind., alleging that the article had been shipped in interstate commerce
on or about September 14, 1942, by the Hygenol Co. from Minneapolis, Minn.;
and charging that it was misbranded.
Analysis showed that the article consisted essentially of acetanilid 1? grains
per tablet, camphor monobromated, cinchonidine sulfate, capsicum, caffeine, and
extracts of plant drugs, including a laxative drug.
The article was alleged to be misbranded (1) in that the statements appear-
ing upon its label, "Cold Tablets * * * For the Belief from Common Head
Colds, * * * For the relief of distress and discomfort due to Common
Head Colds, etc.," were false and misleading since such statements represented
and suggested that the article was effective in the treatment of head colds,
whereas it was not so effective;  (2) in that its labeling failed to bear ade-
*For omission of, or unsatisfactory, ingredients statements, see Nos. 954, 956, 961, 991, 994; inconspicuous-
aess of required label information, No. 958; cosmetic, subject to the drug provisions of the Act, No. 982.
608091?-44 1 
161
quate directions for use since the directions appearing on the label provided/
for an excessive amount of acetanilid and were therefore not adequate for an(
article of such composition; (3) in that its labeling failed to bear such ade-
quate warnings against use by children, and in those pathological conditions
wherein its use might be dangerous to health, in such manner and form as are
necessary for the protection of users, since the article was a laxative and its
-labeling failed to warn that a laxative should not be taken in cases of nausea,
vomiting, abdominal pain,? or other symptoms of appendicitis, and since the
article contained acetanilid and its labeling failed to warn against use by
children; (4) in that its labeling failed to bear such adequate warnings against
.unsafe dosage and methods-and duration of administration in such-manner
and form as are necessary for the,protection of users, since its labeling failed
to warn that frequent or continued use of a preparation containing acetanilid
might cause serious blood disturbances, anemia, collapse, or a dependence on
the drug, and since its labeling also failed to warn that frequent or continued
use of a laxative might result in dependence upon laxatives; and (5) in "that
it was dangerous to health when used in the dosage and with the frequency and
duration prescribed, recommended, and suggested in the labeling thereof, since
the article, when taken in accordance with the directions appearing on the
labeling, "Directions Adults: Take 2 tablets every 2 or 3 hours until bowels
move freely, then take 1 or 2 tablets 3 or 4 times a day until relieved. "Warning!
Do Not Take More Than Six Tablets In Any Twenty-Four Hour Period," would
provide, even with the limitation of 6 tablets a day, a maximum of 9 grains of
acetanilid a day for an indefinite period of time, and was dangerous to health.
On April 5, 1943, no claimant having appeared, judgment of condemnation
was entered and the product was ordered destroyed.