1S58. Misbranding of Udgra Tablets. V. S. v. 62 Boxes, 3 Bottles, and 6 Bottles of
Udgra Tablets. Consent decree of condemnation. Product ordered re-
leased under bond.    (F. D. C. No. 6912.   Sample No. 86830-B.)
On February 27, 1942, the United States attorney for the Northern District
of Illinois filed a libel against 62 boxes, each containing 20 tablets, 3 bottles, each
containing 100 tablets, and 6 bottles, each containing 50 tablets, of the above-
named product at Chicago, 111., alleging that the article had been shipped from
St. Paul, Minn., by Udga, Inc., on or about January 8, 1942.
Analysis showed that the article contained, per tablet, 6.88 grains of bismuth
subcarbonate, 10.23 grains of magnesium oxide, 7.29 grains of sodium bicarbonate,
0.2 grain of Rochelle salt, and a small proportion of saccharine. The statement of
active ingredients was in small, inconspicuous type.
The article was alleged to be misbranded in that certain statements on its
label and in an accompanying circular were false jnd misleading since they
represented and suggested that the article would be efficacious for the relief
of excessive gastric hyperacidity as manifested by sour stomach, heartburn, acid
dyspepsia, excessive gas, belching, and flatulence; and that it would be efficacious
for the relief of persons suffering from stomach ailments caused by improper
diet, irregular eating habits, consuming too many acid-producing foods, or over-
eating.    The article would not be efficacious for such conditions.
The article was alleged to be misbranded further (1) in that the statement of
active ingredients, "contain: Bismuth Subcarbonate; Magnesium Oxide; Sodium
Bicarbonate; Saccharine; Rochelle Salt," appearing on the box label of the
article, was not prominently placed thereon with such conspicuousness as to
render it likely to be read under customary conditions of purchase and use; (2)
in that its labeling failed to bear adequate directions for use since the directions
did not
.provide a limitation as to duration of use; and (3) in that its labeling
did not bear a warning that the article should not be used when abdominal pain,
nausea, vomiting, or other symptoms of appendicitis were present, and that
frequent or continued use might result in dependence on laxatives.
On April 4, 1945, Udga, Inc., claimant, having admitted the facts in the libel,
judgment of condemnation was entered and the product was ordered released un-
der bond for relabeling under the supervision of the Food and Drug Adminis-
tration.