5485. Elixir Albephen and elixir Merbutal. (F.D.C. No. 40468. S. Nos. 67-474
M, 67-478 M.)
INFORMATION FILED : 2-5-58, Dist. Md., against Meredyth Co., a partnership,
Silver Spring, Md., and Irwin T. Sealf on, a partner.
ALLEGED VIOLATION : Between 9-23-55 and 5-16-57, the defendants caused a
quantity of elixir Albephen in 1-gal. btls. to be repacked into 1-pt. btls. and a
quantity of elixir Merbutal in 1-gal. btls. to be repacked into 1-oz. btls., which
acts of repacking resulted in the repacked articles being misbranded while held
for sale after shipment in interstate commerce.
LABEL IN PART: (Btl.) "One Pint Elixir Albephen Each Ounce Contains:
D. Amphetamine Sulfate 15 mg. Thiamin HCL 30 mg. Riboflavin 2.7 mg.
Niacin 40 mg. Alcohol 10? Distributors The Meredyth Company Washing-
ton, D.C. The M Co." and "Physicians Sample One Ounce Elixir Merbutal
Each 5cc (One teaspoonful) contains: Sodium-5-ethyl-secondary butyl barbi-
turate 3 grs. (brand of Butabarbital sodium) Distributors The Meredyth Com-
pany   Washington, D.C."
CHARGE: Elixir Albephen. 502 (a)-the label statement "Each Ounce Con-
tains: D. Amphetamine Sulfate 15 mg. Thiamin HCL 30 mg. Riboflavin
2.7 mg. Niacin 40 mg. Alcohol 10?" was false and misleading since each
ounce of the article contained no d. amphetamine sulfate, no thiamine HC1,
no riboflavin, and no niacin, and contained more than 10 percent of alcohol;
502(d)-the article contained phenobarbital, a derivative of barbituric acid,
which had been found to be, and by regulations designated as, habit forming,
and the label failed to bear the name, and quantity or proportion of such
derivative and in juxtaposition therewith the statement "Warning-May be
habit forming"; 502(e) (2)-the label of the article failed to bear the common
or usual name of the active ingredient, phenobarbital, the name, and quantity
or proportion of hyoscyamine sulfate, atropine sulfate, and hyoscine hydro-
bromide, and the quantity, kind, and proportion of alcohol contained in the
article; and 503(b) (4)-the article was a drug subject to 503(b) (1), and the
label failed to bear the statement "Caution: Federal law prohibits dispensing
without prescription."
Elixir Merbutal.   502(a)-the label statement "Each 5cc (one teaspoonful)
contains: Sodium-5-ethyl-secondary butyl barbiturate 3 grs. (brand of buta-
/barbital sodium)" was false and misleading in that each 5cc of the drug
contained less than 3 grs. of sodium-5-ethyl-secondary butyl barbiturate
(brand of butabarbital sodium); 502(d)-the article contained butabarbital
sodium, a derivative of barbituric acid, which had been found to be, and by
regulations designated as, habit forming; and the label failed to bear the
quantity or proportion of such derivative and in juxtaposition therewith the
statement "Warning-May be habit forming"; and 503(b) (4)-the article was
a drug subject to 503(b)(1), and its label failed to bear the statement
"Caution:   Federal law prohibits dispensing without prescription."
PLEA :   Guilty.
DISPOSITION: 6-27-58. The sentence against the partnership was suspended,
and a fine of $1,000, plus costs, was imposed against the individual.