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]
4021-4040
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 the
Department of Health, Education, and Welfare, and include, where indicated, the
results of investigations by the Department, prior to the institution of the pro-
ceedings. Published by direction of the Secretary of Health, Education, and
Welfare.
CHABLES W. CBAWFOED, Commissioner of Food and Drugs.
WASHINGTON, D. C, November 25, 1958.
CONTENTS*
Pas*
Drugs in violation of prescription
labeling requirements?    18
Drugs and devices actionable be-
cause of failure to bear ade-
quate directions or warning
statements
    18
Page
Drugs actionable because of devia-
tion from official or own stand-
ards 
    32
Drugs and devices actionable be-
cause of false and misleading
claims 
    33
*For presence of a habit-forming narcotic without warning statement, see Nos. 4022, 4024; omission of, or
unsatisfactory, ingredients statements, Nos. 4023, 4024, 4026; failure to bear a label containing an accurate
statement of the quantity of the contents, Nos. 4022-4024; failure to bear a label containing the name and
place of business of the manufacturer, packer, or distributor, Nos. 4022-4024,4026: labeling information not
likely to be read and understood by the ordinary individual under customary conditions of purchase and
use, No. 4033.
277915-53-
Xi
f ,>    DRUGS IN VIOLATION OF PRESCRIPTION LABELING REQUIREMENTS
4021. Misbranding of acetylsalicylic acid tablets, ophthalmic ointment, potas
sium iodide tablets, and rhinitis tablets. U. S. v. 4 Cartoned Bottles, etc.
(F. D. C. No. 34671.    Sample Nos. 36592-L, 70132-L to 70136-L, incl.)
LIBEL FILED :    February 18,1953, Southern District of Ohio.
ALLEGED SHIPMENT : Between August 22 and December 30, 1952, by Eli Lilly &
Co., from Indianapolis, Ind.
PBODTJCT : 4 cartoned bottles of 1 grain acetylsalicylic acid taUets, 133 cartoned
bottles of 5 grain acetylsalicylic acid tablets, 22 cartoned tubes of ophthalmic
ointment, 34 bottles of potassium iodide tablets, and 4 bottles of rhinitis tablets
at Dayton, Ohio.
LABEL, IN PARI : (Bottle) "100 Tablets * * * A. S. A. (Acetylsalicylic Acid,
Lilly) lgr. (0.065 Gm.) * * * Dose-1 tablet as directed by the physician"
and "Tablets * * * A. S. A. (Acetylsalicylic Acid, Lilly) 5 grs. (0.325
Gm.) * * * Adult Dose-1 to 3 tablets as directed by the physician";
(tube) "Ys Ounce Ophthalmic Ointment -*? * * Atropine Sulfate 1 percent
To be used as directed by the physician"; (bottle) "100 * * * Enseals
(Timed Disintegrating Tablets, Lilly) Potassium Iodide 5 grs. (0.325 Gm.)
* * * Adult Dose-1 or 2 'Enseals' as directed by the physician. Indis-
criminate use may be dangerous" and "1000 Tablets   *    *    *   Rhinitis   Full
Strength   *    *    *   Each tablet contains:   Camphor__? ? gr. : 0.0325 Gm.
Quinine Sulfate?y2 gr. : 0.0325 Gm.   Ext. Belladonna Root?? gr.
: 0.0035 Gm. (Total Alkaloids, 1/960 gr.) Camphor being volatile, the exact
quantity cannot be guaranteed. Adult Dose-1 or 2 tablets as directed by the
physician.    Indiscriminate use may be dangerous."
NATURE OF CHARGE: Acetylsalicylic acid tablets (1 grain and 5 grains), potas-
sium iodide tablets, and rhinitis tablets. Misbranding, Section 502 (f) (1),
the labeling of the articles failed to bear adequate directions for use.
Rhinitis tablets. Misbranding, Section 502 (a), the label designation "Tab-
lets * * * Rhinitis" was false and misleading since such designation rep-
resented and suggested that the article was an adequate and effective remedy
for rhinitis, whereas it was not an adequate and effective remedy for rhinitis.
Ophthalmia ointment. Misbranding, Section 503 (b) (4), the article was a
drug subject to Section 503 (b) (i) (B), and the label failed to bear the state-
ment "Caution: Federal law prohibits dispensing without prescription."
DISPOSITION :    March 21,1953.   Default decree of condemnation and destruction.
DRUGS AND DEVICES ACTIONABLE BECAUSE OF FAILURE TO BEAR
ADEQUATE DIRECTIONS OR WARNING STATEMENTS*