[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR357.150]

[Page 306-307]
 
                        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--
 
                  Subpart B_Anthelmintic Drug Products
 
Sec.  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), 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. 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:

------------------------------------------------------------------------
                                              Dosage (taken as a single
                  Weight                              dose) \1\
------------------------------------------------------------------------
Less than 25 pounds or under 2 years old..  Do not use unless directed
                                             by a doctor.
 25 to 37 pounds..........................  125 milligrams.
 38 to 62 pounds..........................  250 milligrams.
 63 to 87 pounds..........................  375 milligrams.
 88 to 112 pounds.........................  500 milligrams.
113 to 137 pounds.........................  625 milligrams.
138 to 162 pounds.........................  750 milligrams.

[[Page 307]]


163 to 187 pounds.........................  875 milligrams.
188 pounds and over.......................  1,000 milligrams.
------------------------------------------------------------------------
\1\ Depending on the product, the label should state the quantity of
  drug as a liquid measurement (e.g., teaspoonsful) or as the number of
  dosage units (e.g., tablets) to be taken for the varying body weights.
  (If appropriate, it is recommended that a measuring cup graduated by
  body weight and/or liquid measurement be provided with the product.)
  Manufacturers should present this information as appropriate for their
  product and may vary the format of this chart as necessary.

    (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.

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