2832. Misbranding of mineral oil.   U. S. v. 72 Bottles   *   *   *.    (F. D. C. No.
27188.    Sample No. 46141-K.)
LIBEL FILED:   May 6, 1949, Southern District of Iowa.
ALLEGED SHIPMENT : On or about February 24, 1949, by the Halitosine Co., from
St. Louis, Mo.
PRODTTOT:   72   1-pint bottles of mineral oil at Keokuk, Iowa.
LABEL, IN PART: "Domino Mineral Oil U. S. P. Extra Heavy * * * Di-
rections * * * infants * * * ? teaspoonful * * * Prepared by
Domino Products Co.   St. Louis, Mo.-Dallas, Texas."
NATURE OF CHARGE: Misbranding, Section 502 (f) (2), the article failed to bear
such adequate warnings against use by children wher-e its use may be danger-
ous to health and against unsafe dosage and methods and duration of ad-
ministration, in such manner and form as are necessary for the protection of
users. The labeling of the article failed to warn that the article should not
be taken at any time other than bedtime or administered to infants except on
advice of a physician.
Further misbranding, Section 502 (j), the article was dangerous to health
when used in the dosage and with the frequency and duration prescribed,
recommended, and suggested in its labeling, namely, "Directions * * *
infants * * * ? teaspoonful," since mineral oil when given to infants
sometimes is aspirated and causes lipoid pneumonia.
DISPOSITION :   June 30, 1949.   Default decree of condemnation and destruction.
DRUGS ACTIONABLE BECAUSE OF FAILURE TO BEAR
ADEQUATE DIRECTIONS OR WARNING STATEMENTS*