6170. Cough medicine.   (F.D.C. No. 44230.   S. No. 64-428 P.)
QUANTITY:   415 cases, 12   2-oz. btls. each, at Stamford, Conn.
SHIPPED : Between 2-16-59 and 3-11-59, from Long Island City, N.Y., by Den-
ver Chemical Mfg. Co.
LABEL IN PAST : (Btl) "Dr. Hand's Cough Medicine For Children For Coughs
Due to Colds Each 30 cc contains: Hyoscyamus alkaloids .06 mg. Sodium
Bromide USP .4 gm. Sanguinaria Fluidextract, Ipecac Fluidextract USP,
Tolu Balsam Tincture USP, Menthol USP, Alcohol 4? * * * Hand Medi-
cine Co., Inc., New York, N.Y.   Successors to D. B. Hand, M.D. * * * 60 cc."
ACCOMPANYING LABELING: (Leaflet in ctn.) "Today's Answer to Children's
Coughs Due to Colds   Dr. Hand's Cough Medicine for Children."
LIBELED :   2-10-60, Dist. Conn.
CHARGE: 502(a)-when shipped, the labeling of the article contained false
and misleading representations that the article was an adequate and effec-
tive treatment for coughs due to virus and bacterial infections; tonsillitis;
pharyngitis; laryngitis; tracheitis; and bronchitis; 502(f)(1)-the labeling:
of the article failed to bear adequate directions for use since it provided for
unsupervised administration to infants and small children; and 502(f) (2) -
the article failed to bear adequate warnings against use since the labeling
failed to warn that the article should not be taken by persons with a high
fever or persistent cough unless directed by a physician; that the article was
not to be used by elderly persons or by children under six (6) years of age
unless directed by a physician: that the recommended dosage should not be
exceeded; that if dryness of the mouth occurred dosage should be decreased:
and that one should discontinue use if rapid pulse, dizziness, or blurring of
vision occurred.
DISPOSITION :    6-17-60.   Default-destruction.