27998. Coldene vitamin tonic with iron.    (F.D.C. No. 45882.    S. No. 35-812 R.) 
QUANTITY :   15,600 individually ctnd. btls. at Brooklyn, N.Y.
SHIPPED:    11-30-59, from Chicago, Ill., by Sanco Drug Co.
LABEL IN PART: (Btl. and ctn.) "Coldene Vitamin Tonic with Iron * * * Each 
fluid oz. (2 Tablespoonfuls) contains: * * * Riboflavin (B2) 4 mg. * * * 
Pharma-Craft Corporation, Distrs. Cranbury, N.J."
ACCOMPANYING LABELING: Leaflet in carton entitled "Coldene Liquid Cold 
Medicine."
RESULTS OF INVESTIGATION : Analysis showed that the article contained approxi- 
mately 68 percent of the declared amount of riboflavin.
LIBELED :    5-12-61, E. Dist. N.Y.
CHARGE: 402(b) (1)—when shipped and while held for sale, the valuable con- 
stituent riboflavin, had been in part omitted or abstracted from the article; 
403(a)—the label statement "Each fluid oz. contains: * * * Riboflavin (B2) 
4 mg." was false and misleading as applied to an article which contained less 
than the declared amount of riboflavin; the label statements "M.D.R. for 
Niacinamide * * * not established." and "Need in human nutrition for * * * 
Methionine is not established," were false and misleading since they were 
contrary to fact; and 403(j)—the article purported to be and was represented 
as a food for special dietary use by reason of its vitamin and mineral content 
and its label failed to bear, as required by regulations, a statement of the 
proportion of the minimum daily requirement for vitamins Bi and B2, and 
niacinamide and for iron supplied by such food when consumed in a specified 
quantity during the period of one day.
The libel alleged also that the article was misbranded under the provisions 
of the Act relating to drugs as reported in notices of judgment on drugs and 
devices, No. 6680.
DISPOSITION :   6-8-61.   Default—destruction.