[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.308]
[Page 81]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 201 LABELING--Table of Contents
Subpart G Specific Labeling Requirements for Specific Drug Products
Sec. 201.308 Ipecac syrup; warnings and directions for use for
over-the-counter sale.
(a) It is estimated that each year about 500,000 accidental
poisonings occur in the United States and result in approximately 1,500
deaths, of which over 400 are children. In the emergency treatment of
these poisonings, ipecac syrup is considered the emetic of choice. The
immediate availability of this drug for use in such situations is
critical, since rapid treatment may be the difference between life and
death. The restriction of this drug to prescription sale limits its
availability in emergencies. On the other hand, it is the consensus of
informed medical opinion that ipecac syrup should be used only under
medical supervision in the emergency treatment of poisonings. In view of
these facts, the question of whether ipecac syrup labeled as an
emergency treatment for use in poisonings should be available over the
counter has been controversial.
(b) In connection with its study of this problem, the Food and Drug
Administration has obtained the views of medical authorities. It is the
unanimous recommendation of the American Academy of Pediatrics, the
American Association of Poison Control Centers, the American Medical
Association, and the Medical Advisory Board of the Food and Drug
Administration that ipecac syrup in 1 fluid ounce containers be
permitted to be sold without prescription so that it will be readily
available in the household for emergency treatment of poisonings, under
medical supervision, and that the drug be appropriately packaged and
labeled for this purpose.
(c) In view of the above recommendations, the Commissioner of Food
and Drugs has determined that it is in the interest of the public health
for ipecac syrup to be available for sale without prescription, provided
that it is packaged in a quantity of 1 fluid ounce (30 milliliters), and
its label bears, in addition to other required label information, the
following, in a prominent and conspicuous manner:
(1) A statement conspicuously boxed and in red letters, to the
effect: ``For emergency use to cause vomiting in poisoning. Before
using, call physician, the Poison Control Center, or hospital emergency
room immediately for advice.''
(2) A warning to the effect: ``Warning--Keep out of reach of
children. Do not use in unconscious persons. Ordinarily, this drug
should not be used if strychnine, corrosives such as alkalies (lye) and
strong acids, or petroleum distillates such as kerosine, gasoline, coal
oil, fuel oil, paint thinner, or cleaning fluid have been ingested.''
(3) Usual dosage: 1 tablespoon (15 milliliters) in persons over 1
year of age.
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