[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: 21CFR201.63]
[Page 42-43]
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 C Labeling Requirements for Over-the-Counter Drugs
Sec. 201.63 Pregnancy/breast-feeding warning.
(a) The labeling for all over-the-counter (OTC) drug products that
are intended for systemic absorption, unless specifically exempted,
shall contain a general warning under the heading ``Warning'' (or
``Warnings'' if it appears with additional warning statements) as
follows: ``If pregnant or breast-feeding, ask a health professional
before use.'' [first four words of this statement in bold type] In
addition to the written warning, a symbol that conveys the intent of the
warning may be used in labeling.
(b) Where a specific warning relating to use during pregnancy or
while nursing has been established for a particular drug product in a
new drug application (NDA) or for a product covered by an OTC drug final
monograph in part 330 of this chapter, the specific warning shall be
used in place of the warning in paragraph (a) of this section, unless
otherwise stated in the NDA or in the final OTC drug monograph.
(c) The following OTC drugs are exempt from the provisions of
paragraph (a) of this section:
(1) Drugs that are intended to benefit the fetus or nursing infant
during the period of pregnancy or nursing.
(2) Drugs that are labeled exclusively for pediatric use.
[[Page 43]]
(d) The Food and Drug Administration will grant an exemption from
paragraph (a) of this section where appropriate upon petition under the
provisions of Sec. 10.30 of this chapter. Decisions with respect to
requests for exemptions shall be maintained in a permanent file for
public review by the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
(e) The labeling of orally or rectally administered OTC aspirin and
aspirin-containing drug products must bear a warning that immediately
follows the general warning identified in paragraph (a) of this section.
The warning shall be as follows:
``It is especially important not to use'' (select ``aspirin'' or
``carbaspirin calcium,'' as appropriate) ``during the last 3 months of
pregnancy unless definitely directed to do so by a doctor because it may
cause problems in the unborn child or complications during delivery.''
[47 FR 54757, Dec. 3, 1982, as amended at 55 FR 27784, July 5, 1990; 59
FR 14364, Mar. 28, 1994; 64 FR 13286, Mar. 17, 1999; 68 FR 24879, May 9,
2003]
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