1562. Misbranding of Col-Chex, Diarrhea and Flux Remedy, and Coldex.    U. S. v.
C.  B. Drug Sales  Co., Inc.    Plea of guilty.    Fine, ?10O.     (F. D. C.  No.
11332.    Sample Nos. 35395-F to 35397-F, incl.)
INFORMATION FILED:   February 14, 1944, Western District of North Carolina,
against the C. B. Drug Sales Co., Inc., Charlotte, N. C.
ALLEGED SHIPMENT :   Between the approximate dates of December 31, 1942, and
March 11, 1943, from the State of North Carolina into the State of South
Carolina.
PRODUCT: Analyses disclosed that the Col-Chex was composed of a mineral
oil base containing camphor, menthol, oil of Eucalyptus, and ephedrine; that
the Diarrhea and Flux Remedy was a mixture containing salol, chalk, sodium
phenolsulfonate, bismuth salicylate, and plant material; and that the Coldex
was a mixture containing 20.4 grains of sodium salicylate per fluid ounce and
also containing menthol and camphor, emodin-bearing drugs, and other plant
material.
NATURE OF CHARGE:    Col-Chex, misbranding, Section 502 (a)., the label state-(
ments, "Col-Chex for Nose & Throat    *    *    *    Col-Chex is recommended as ?  -
an aid in preventing colds and to check acute symptoms of trouble in nasal
leading since the article would not be efficacious in the cure, mitigation, treat-
ment, or prevention of colds nor in the treatment of all acute symptoms of
trouble in the nasal and throat passages; and certain statements in 
 an
accompanying leaflet regarding another drug, Coldex, were false and misleading,
since they represented and suggested that the other drug would be efficacious
in the cure, mitigation, treatment, or prevention of colds, coughs, and flu, and
that the use of the other drug would often save the whole family from a
period of sickness, whereas the other drug would not be efficacious for those
purposes.
Diarrhea and Flux Remedy, misbranding, Section 502 (a), the label state-
ments, "Diarrhea and Flux Remedy An efficient Antiferment and intestinal
antiseptic and astringent for the treatment of Diarrhea, Dysentery, Colitis
and Flux," were false and misleading since the article would not be an effica-
cious remedy in the cure, mitigation, treatment, or prevention of diarrhea or
flux and would not be an efficient antiferment or intestinal antiseptic or
astringent for the treatment of diarrhea, dysentery, colitis, or flux.
Coldex, misbranding, Section 502 (a), the name "Coldex" was misleading in
that it represented and implied that the article would be a competent treat-
ment for colds, whereas it would not be a competent treatment for colds; and
the label statement "For Relief of Colds" was false and misleading since the
article would not be an effective treatment for the relief of colds. Further
misbranding, Section 502 (f) (1), the labeling of the article failed to bear
adequate directions for use in that the directions, "Two Teaspoonfuls in Water
Then one teaspoonful every three or four hours until bowels move freely.
Thereafter three times a day until desired results are obtained," suggested
continuous use of the article, whereas the article was a laxative, and frequent
or continued use might result in dependence upon laxatives to move the bowels;
and, Section 502 (f) (2), the labeling of the article failed to warn that it
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 upon laxatives to move the bowels.
DISPOSITION : April 9, 1945. A plea of guilty having been entered on behalf of
the defendant, the court imposed a fine of $100.