1756. Misbranding of "Jarabe Calmante de la Sra. Wlnslow-Laxante" (Mrs.
Wlnslovr's Soothing Syrup). II. S. v. 30 Gross of "Jarabe Calmante de la
Sra. Wlnslow-Laxante" (Mrs. Winslow's Soothing Syrup). Default de-
cree of forfeiture and destruction. (F. D. C. No. 12720. Sample No.
33161-F.)
LIBEL FILED:   July 12, 1944; amended August 22> 1944, District of Puerto Rico.
ALLEGED SHIPMENT :    On or about October 23, 1943, by the Anglo-American Drug
Co., from New York, N. X.
PRODUCT :   30 gross of 45-cc. bottles of soothing syrup at Santurce, P. R.
Examination showed that the product was a syrupy liquid containing laxa-?1
 tive drugs such as rhubarb and senna, flavored with essential oils such as anise
oil.
?     .
LABEL, IN PAST : (Translated from the Spanish) "Each bottle contains 45 cubic
centimeters of the following formula: Fluidextract of Rhubarb, 0.08-Fluid-
extract of Senna, 0.19-Sodium Citrate, 1.50-Sodium bicarbonate, 0.17-Glucose,
31.20-Anise Oil, 0.05 cc.-Caraway-seed Oil, 0.03 cc".-Coriander Oil, 0:01 ec-
Fennel Oil, 0.07 cc.-Glycerine, 2.8 cc.-water sufficient to make 45 cubic centi-
meters."
NATURE OF CHARGE:   Misbranding,  Section 502(a),  the designation,  "Jarabe
Calmante" (soothing syrup), which appeared upon the wrapper, bottle label,
and circular wrapped around the bottle, was false and misleading since'the
effect of the article would not be soothing; and certain statements in the label-    (
ing were false and misleading since they represented and suggested that the    \
article was harmless and would be an effective and appropriate treatment for
colics, diarrhea, vomiting, congestions, fevers, gastric indigestion in children,
stomach acidity, and constipation. The. article, which contained irritant
cathartic drugs, was not harmless and would not fulfill the promises of benefit
stated and implied.
Further misbranding, Section 502(a), the following statement (translated
from the Spanish) in the circular was misleading since it created the impres-
sion that the article contained no harmful and deleterious drugs: "To mothers
so they may know the true quality of Mrs. Winslow's Soothing Syrup we
describe as follows the ingredients and you will notice that it does not con-
tain opium, morphine, alcohol, strong purgatives or other substances harmful
to children."   The article contained cathartic drugs which might be harmful.
Further misbranding, Section 502(a), the following statements (translated
from the Spanish) in the circular were false and misleading since neither the
formula nor the ingredients have been approved by the Department of Public
Health of the United States: "Its formula and ingredients have been approved
by all the Departments of Public Health of the different countries of North
and South America"; and the statement on the wrapper, "Puramente vegetal,"
was false and misleading since the ingredients sodium bicarbonate and sodium
citrate are not vegetal.
Section 502(f)(2), the labeling failed to bear adequate warnings against
administration of the article in case of abdominal pain, nausea, vomiting, or
other symptom of appendicitis, or warning that the frequent and continued
use of the article might result in dependence upon laxatives to move the
bowels.
DISPOSITION : December 21, 1945. No claimant having appeared, judgment of
forfeiture was entered and the product was ordered destroyed. The con-
tainers were ordered salvaged and delivered to the Anglo-American Drug Co.