659. Misbranding of Wo. 48511-0 Tablets and Goodwin's Laxative Cold Tablets.
IT. S. v. 81,600 No. 48511-0 Tablets in bulk containers and 6,330 Packages
of Goodwin's Laxative Cold Tablets. Consent decree of condemnation.
Product  ordered released under bond to  be repackaged  and relabeled.
(F. D. C. No. 4883.   Sample Nos. 50244-E, 50246-E.)
This case covered shipments of tablets in bulk containers, a portion of which
had been repackaged and relabeled "Goodwin's Laxative Cold Tablets" by the con-
signee. The repackaged tablets would be dangerous to health when used accord-
ing to directions. The labeling of both lots of tablets failed to bear adequate
warning statements and satisfactory ingredient statements. Furthermore, the
labeling of the bulk tablets failed to bear directions for use, and that of the
repackaged tablets also bore false and misleading therapeutic claims.
On June 7,1941, the United States attorney for the District of Maryland filed a
libel against the above-named products at Baltimore, Md., alleging that they had
been shipped on or about February 24 and 26 and March 4 and 10,1941, by Sharp
& Dohme from Philadelphia, Pa., and that having been so shipped, they remained
in interstate commerce on the premises of the Read Drug & CMmlcal Co. at Balti-
more, Md.; and charging that they were misbranded. The bulk tablets were
labeled in part: (Container) "Sharp & Dohme Philadelphia, Pa. * * * No.
48511-C   Made for Read Drug & Chemical Co.   Baltimore, Md."
Analyses of samples taken from the bulk containers and the retail cartons
showed that each tablet contained acetanilid (approximately 2 grains), quinine
sulfate (? grain), podophyllin, capsicum, and belladonna extract.
The repackaged tablets were alleged to be misbranded: (1) In that they would
be dangerous to health when used in the dosage and with the frequency and
duration prescribed, recommended, and suggested in the labeling, namely, "Adults:
1 tablet every 4 hours until bowels move freely, then 1 tablet 2 or 3 times daily,"
since if taken in accordance with such directions they might result in the patient's
ingesting amounts of acetanilid that would be dangerous to health. (2) In that
the name "Goodwin's Laxative Cold Tablets" and the statements "Effective in the
Treatment of Colds. Relieves the Feverish Condition which Accompany Colds,"
and 'Keeps the Bowels Active," appearing in the labeling, were false and mis-
leading since they gave the impression that the article,was an effective'treatment
for colds; whereas it was not an effective treatment for cdldVaftd would not ful-
fill the promises of benefit made and implied by such statements. (3) In that a
quantity of belladonna alkaloids was present in the article and the labeling did
not bear a statement of the quantity or proportion of the belladonna alkaloids
present.
Both lots of tablets were alleged to be misbranded in that the labeling did not
bear adequate warnings against use in those pathological conditions or by children
where their use might be dangerous to health and against unsafe dosage and
duration of administration, in such manner and form, as are necessary for the
protection of users, since said labeling bore no warnings that their use should be
discontinued if a skin rash appeared; that they should be used cautiously if dry-
ness of the throat occurred; that their use should be discontinued if rapid pulse
or blurring of the vision resulted; that the preparation should not be taken by
children; that frequent or continued use might be dangerous to health by causing
serious blood disturbances, anemia, collapse, or dependence on the drug; that the
preparation should not be taken by elderly people except on competent advice;
that frequent use of the preparatioa, might lead to dependence upon laxatives to
move the bowels; and (bulk tablets only) since said labeling did not carry a warn-
ing against use of the article in the presence of abdominal pain, nausea, vomiting,
or other symtoms of appendicitis.
The bulk tablets were alleged to be misbranded further (1) in that the label
failed to bear adequate directions for use since it did not bear any directions for
use; and (2) in that the labeling did not bear the common or usual name of each
active ingredient, namely, acetanilid, quinine sulfate, podophyllin, capsicum, and
belladonna extract, and in that it did not bear a statement of the quantity or
proportion of acetanilid and belladonna extracts.
On August 6, 1941, the Read Drug & Chemical Co., claimant, having admitted
the allegations of the libel, judgment of condemnation was entered and the
product was ordered released under bond conditioned that it be repackaged and
relabeled under the supervision of the Food and Drug Administration.
DRUGS ACTIONABLE BECAUSE OF FAILURE TO BEAR ADEQUATE
DIRECTIONS OR WARNING STATEMENTS1