---
kind: "section"
citation: "21 C.F.R. § 357.250"
title: "21"
number: "357.250"
heading: "Labeling of cholecystokinetic drug products."
url: "https://uscodex.org/cfr/21/357.250"
---

# §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)](#b), may also be used, as provided in [§ 330.1(c)(2)](/cfr/21/330.1.md?p=c-2), subject to the provisions of [section 502](/cfr/21/502.md) of the act relating to misbranding and the prohibition in [section 301(d)](/cfr/21/301.md?p=d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of [section 505(a)](/cfr/21/505.md?p=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.
- (e) The word “physician” may be substituted for the word “doctor” in any of the labeling statements in this section.

## Notes

### Amendments

[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]

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

### Amendments

[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]