[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR357.250]

[Page 291-292]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 357--MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
               Subpart C--Cholecystokinetic Drug Products
 
Sec. 357.250  Labeling of cholecystokinetic drug products.

    (a) Statement of identity. The labeling of the product contains the 
established name of the drug, if any, and identifies the product as a 
``gallbladder diagnostic agent.''
    (b) Indications. The labeling of the product states, under the 
heading ``Indications,'' the following: ``For the contraction of the 
gallbladder during diagnostic gallbladder studies.'' Other truthful and 
nonmisleading statements, describing only the indications for use that 
have been established and listed in this paragraph (b), may also be 
used, as provided in Sec. 330.1(c)(2), subject to the provisions of 
section 502 of the act relating to misbranding and the prohibition in 
section 301(d) of the act against the introduction or delivery for 
introduction into interstate commerce of unapproved new drugs in 
violation of section 505(a) of the act.
    (c) Warnings. [Reserved]
    (d) Directions. The labeling of the product contains the following 
statements under the heading ``Directions'':
    (1) ``Take only when instructed by a doctor:''
    (2) For products containing 50-percent aqueous emulsion of corn oil.
    (i) ``Shake well before using.''
    (ii) Oral dosage is 60 milliliters 20 minutes before diagnostic 
gallbladder x-ray or as directed by a doctor.
    (3) For products containing hydrogeneated soybean oil. Oral dosage 
is 12.4 grams in a suitable, water-dispersible powder in 2 to 3 ounces 
of water. Stir briskly to prepare a suspension before using. Drink 20 
minutes before diagnostic gallbladder x-ray or as directed by a doctor.

[[Page 292]]

    (e) The word ``physician'' may be substituted for the word 
``doctor'' in any of the labeling statements in this section.

[48 FR 27005, June 10, 1983, as amended at 51 FR 16267, May 1, 1986; 52 
FR 7830, Mar. 13, 1987; 54 FR 8321, Feb. 28, 1989]