---
kind: "section"
citation: "21 C.F.R. § 357.150"
title: "21"
number: "357.150"
heading: "Labeling of anthelmintic drug products."
url: "https://uscodex.org/cfr/21/357.150"
---

# §357.150. Labeling of anthelmintic 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 “pinworm treatment.”
- (b) **Indication.** The labeling of the product states, under the heading “Indication,” the following: “For the treatment of pinworms.” 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.** The labeling of the product contains the following warnings under the heading “Warnings”:
  - (1) “Abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur after taking this drug. If any of these conditions persist consult a doctor.”
  - (2) “If you are pregnant or have liver disease, do not take this product unless directed by a doctor.”
- (d) **Directions.** The labeling of the product contains the following information under the heading “Directions”:
  - (1) **Adults, children 12 years of age and over, and children 2 years to under 12 years of age—** Oral dosage is a single dose of 5 milligrams of pyrantel base per pound, or 11 milligrams per kilogram, of body weight not to exceed 1 gram. Dosing information should be converted to easily understood directions for the consumer using the following dosage schedule:
  - (2) “Read package insert carefully before taking this medication. Take only according to directions and do not exceed the recommended dosage unless directed by a doctor. Medication should only be taken on time as a single dose; do not repeat treatment unless directed by a doctor. When one individual in a household has pinworms, the entire household should be treated unless otherwise advised. See Warnings. If any worms other than pinworms are present before or after treatment, consult a doctor. If any symptoms or pinworms are still present after treatment, consult a doctor.
  - (3) “This product can be taken any time of day, with or without meals. It may be taken alone or with milk or fruit juice. Use of a laxative is not necessary prior to, during, or after medication.”
- (e) **Optional wording.** The word “physician” may be substituted for the word “doctor” in any of the labeling statements in this section.

## Notes

### Amendments

[51 FR 27759, Aug. 1, 1986; 52 FR 7831, Mar. 13, 1987, as amended at 53 FR 35810, Sept. 15, 1988]

### Source

Source: 51 FR 27759, Aug. 1, 1986, unless otherwise noted.

### Authority

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

### Amendments

[51 FR 27759, Aug. 1, 1986; 52 FR 7831, Mar. 13, 1987, as amended at 53 FR 35810, Sept. 15, 1988]