[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: 21CFR201.314]
[Page 82-84]
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. 201.314 Labeling of drug preparations containing salicylates.
(a) The label of any oral drug preparation intended for sale without
prescription and which contains any salicylate ingredient (including
aspirin, salicylamide, other salicylates, and combinations) must
conspicuously bear, on a clearly contrasting background, the warning
statement: ``Keep out of reach of children [highlighted in bold type].
In case of overdose, get medical help or contact a Poison Control Center
right away,'' or ``Keep out of reach of children [highlighted in bold
type],'' except that if the article is an aspirin preparation, it shall
bear the first of these warning statements. Such a warning statement is
required for compliance with section 502(f)(2) of the Federal Food,
Drug, and Cosmetic Act and is intended to guard against accidental
poisonings. Safety closures that prevent access to the drug by young
children are also recommended to guard against accidental poisonings.
(b) Effervescent preparations and preparations containing para-
aminosalicylate as the only salicylate
[[Page 83]]
ingredient are exempted from this labeling requirement.
(c) Aspirin tablets sold as such and containing no other active
ingredients, except tablets which cannot be readily subdivided into a
child's dose because of their coating or size, should always bear dosage
directions for each age group down to 3 years of age, with a statement
such as ``For children under 3 years of age, consult your physician.''
It is recommended that:
(1) Aspirin tablets especially made for pediatric use be produced
only in 1\1/4\-grain size to reduce the hazard of errors in dosage;
(2) By June 1, 1967, manufacturers and distributors of 1\1/4\-grain
size aspirin tablets discontinue the distribution of such tablets in
retail containers containing more than 36 tablets, to reduce the hazard
of accidental poisoning;
(3) The flavoring of 5-grain aspirin tablets or other ``adult
aspirin tablets'' be discontinued; and
(4) Labeling giving undue emphasis to the pleasant flavor of
flavored aspirin tablets be discontinued.
(d) Salicylate preparations other than aspirin tablets sold as such
may, at the option of the distributor, be labeled for use by adults
only. If their labeling and advertising clearly offer them for
administration to adults only.
(e)(1) It is the obligation of the distributor who labels a
salicylate preparation for administration to children to make certain
that the article is suitable for such use and labeled with adequate
directions for use in the age group for which it is offered, but in no
case should such an article bear directions for use in children under 3
years of age. If the directions provide for administration to children
as young as 3 years of age, the label should bear the statement, ``For
children under 3 years of age consult your physician.'' However, if the
directions provide for administration to children only of an age greater
than 3 years (for example, the dosage instructions provide for
administration of the article to children only down to age 6), the label
should bear a statement such as, ``For younger children consult your
physician.''
(2) A statement such as, ``For children under 3 years of age consult
your physician'' or ``For younger children consult your physician'' is
not required on the label of an article clearly offered for
administration to adults only.
(f) If the labeling or advertising of a salicylate preparation
offers it for use in arthritis or rheumatism, the label and labeling
should clearly state that the beneficial effects claimed are limited to:
``For the temporary relief of minor aches and pains of arthritis and
rheumatism.'' The qualifying phrase ``for the temporary relief of minor
aches and pains'' should appear with the same degree of prominence and
conspicuousness as the phrase ``arthritis and rheumatism''. The label
and labeling should bear in juxtaposition with such directions for use
conspicuous warning statements to the effect: ``Caution: If pain
persists for more than 10 days, or redness is present, or in conditions
affecting children under 12 years of age, consult a physician
immediately.'' The salicylate dosage should not exceed 60 grains in a
24-hour period or 10 grains in a 4-hour period. If the article contains
other analgesics, the salicylate dosage should be appropriately reduced.
(g)(1) The label of any drug containing more than 5 percent methyl
salicylate (wintergreen oil) should bear a conspicuous warning such as:
``Do not use otherwise than as directed.'' These drug products must also
include the ``Keep out of reach of children'' warning and the accidental
ingestion warning as required in Sec. 330.1(g) of this chapter.
(2) If the preparation is a counterirritant or rubefacient, it
should also bear a caution such as, ``Caution: Discontinue use if
excessive irritation of the skin develops. Avoid getting into the eyes
or on mucous membranes.'' (See also Sec. 201.303.)
(h)(1) The labeling of orally or rectally administered over-the-
counter drug products containing aspirin or nonaspirin salicylates as
active ingredients subject to this paragraph is required to prominently
bear the following warning: ``Reye's syndrome [subheading in bold type]:
Children and teenagers who have or are recovering from chicken pox or
flu-like symptoms should not use this product. When using this product,
if changes in behavior with nausea and vomiting occur,
[[Page 84]]
consult a doctor because these symptoms could be an early sign of Reye's
syndrome, a rare but serious illness.''
(2) This warning statement shall appear on the immediate container
labeling. In cases where the immediate container is not the retail
package, the retail package also must bear the warning statement. In
addition, the warning statement shall appear on any labeling that
contains warnings and, in such cases, the warning statement shall be the
first warning statement under the heading ``Warnings.''
(3) Over-the-counter drug products subject to this paragraph and
labeled solely for use by children (pediatric products) shall not
recommend the product for use in treating flu or chicken pox.
(4) Any product subject to paragraphs (h)(1), (h)(2), and (h)(3) of
this section that is not labeled as required by these paragraphs and
that is initially introduced or initially delivered for introduction
into interstate commerce after the following dates is misbranded under
sections 201(n) and 502(a) and (f) of the Federal Food, Drug, and
Cosmetic Act.
(i) Compliance by October 18, 2004, for OTC drug products containing
aspirin and nonaspirin salicylates as an active ingredient and marketed
under a new drug application or abbreviated new drug application.
(ii) Compliance by April 19, 2004, for OTC antidiarrheal and
overindulgence drug products that contain bismuth subsalicylate as an
active ingredient and have annual sales greater than $25,000.
(iii) Compliance by April 18, 2005, for OTC antidiarrheal and
overindulgence drug products that contain bismuth subsalicylate as an
active ingredient and have annual sales less than $25,000.
(iv) Compliance dates for all other OTC drug products containing
aspirin and nonaspirin salicylates as an active ingredient and marketed
under an OTC drug monograph (for internal analgesic, antipyretic, and
antirheumatic drug products, or for menstrual drug products) will be
established when the final monographs for those products are published
in a future issue of the Federal Register. In the interim, these
products should continue to be labeled with the previous Reye's syndrome
warning that appears in paragraph (h)(1) of this section.
[40 FR 13998, Mar. 27, 1985, as amended at 51 FR 8182, Mar. 7, 1986; 53
FR 21637, June 9, 1988; 53 FR 24830, June 30, 1988; 64 FR 13291, Mar.
17, 1999; 65 FR 8, Jan. 3, 2000; 68 FR 18869, Apr. 17, 2003]
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