[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR341.85]

[Page 247-249]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 341--COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
                           Subpart C--Labeling
 
Sec. 341.85  Labeling of permitted combinations of active ingredients.

    The statements of identity, indications, warnings, and directions 
for use, respectively, applicable to each ingredient in the product may 
be combined to eliminate duplicative words or phrases so that the 
resulting information is clear and understandable.
    (a) Statement of identity. For a combination drug product that has 
an established name, the labeling of the product states the established 
name of the combination drug product, followed by the statement of 
identity for each ingredient in the combination, as established in the 
statement of identity sections of the applicable OTC drug monographs. If 
there is no established name, the labeling of the product states the 
statement of identity for each ingredient in the combination, as 
established in the statement of identity sections of the applicable OTC 
drug monographs, unless otherwise stated in this paragraph (a).
    (1) For permitted combinations identified in Sec. 341.40(a), (c), 
(f), (g), (l), (m), (n), (o), (q), and (r) containing an analgesic-
antipyretic active ingredient. The analgesic-antipyretic component of 
the product shall be identified as a ``pain reliever'' or ``analgesic 
(pain reliever).'' If the product is also labeled to relieve fever, then 
the analgesic-antipyretic component is identified as a ``pain reliever-
fever reducer'' or ``analgesic (pain reliever)-antipyretic (fever 
reducer).''
    (2) [Reserved]
    (b) Indications. The labeling of the product states, under the 
heading ``Uses,'' the indication(s) for each ingredient in the 
combination, as established in the indications sections of the 
applicable OTC drug monographs, unless otherwise stated in this 
paragraph (b). Other truthful and nonmisleading statements, describing 
only the indications for use that have been established and listed in 
the applicable OTC drug monographs or listed in this paragraph (b), may 
also be used, as provided in Sec. 330.1(c)(2) of this chapter, subject 
to the provisions of section 502 of the Federal Food, Drug, and Cosmetic 
Act (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.
    (1) For permitted combinations containing an analgesic-antipyretic 
active ingredient identified in Sec. 341.40(a), (c), (f). (g), (l), (m), 
(n), (o), (q), and (r) when labeled for relief of general cough-cold 
symptoms and/or the common cold.
    (i) The labeling for the analgesic-antipyretic ingredients states 
``[bullet] temporarily relieves [bullet] minor aches and pains [bullet] 
headache'' and ``[bullet] temporarily reduces fever''.
    (ii) The labeling for the cough-cold ingredient(s) may follow a 
separate bullet(s) or may be combined with the relieves part of the 
indication in paragraph (b)(1)(i) of this section.
    (2) For permitted combinations containing an analgesic-antipyretic 
active ingredient identified in Sec. 341.40(a), (c), (f), (g), (m), (q), 
and (r) when labeled for relief of hay fever/allergic rhinitis and/or 
sinusitis symptoms.
    (i) The labeling for the analgesic-antipyretic ingredients states 
``[bullet] temporarily relieves [bullet] minor aches and pains [bullet] 
headache''.

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    (ii) The indication(s) for the cough-cold ingredient(s) consists of 
the labeling for antihistamines in Sec. 341.72(b)(1) or (b)(2) and/or 
nasal decongestants in Sec. 341.80(b)(1)(ii) and/or (b)(1)(iii), as 
appropriate, and the labeling for any other cough-cold ingredient 
present in the combination. This labeling may follow a separate 
bullet(s) or may be combined with the indication in paragraph (b)(2)(i) 
of this section.
    (3) For permitted combinations containing an oral analgesic-
antipyretic active ingredient identified in Sec. 341.40(a), (c), (f), 
(g), (m), (q), and (r) when labeled for relief of general cough-cold 
symptoms and/or the common cold and for relief of hay fever/allergic 
rhinitis and/or sinusitis symptoms. The labeling states both indications 
in paragraphs (b)(1) and (b)(2) of this section.
    (4) For permitted combinations containing an oral anesthetic-
analgesic active ingredient identified in Sec. 341.40(k), (s), (t), (z), 
(aa), and (bb). The labeling for the anesthetic-analgesic ingredients in 
part 356 of this chapter should be used.
    (5) For permitted combinations containing camphor, menthol, and 
eucalyptus oil identified in Sec. 341.40(u). The labeling for 
antitussive ingredients in Sec. 341.74(b) should be used.
    (6) For permitted combinations containing levmetamfetamine with 
aromatics identified in Sec. 341.40(v). The labeling for nasal 
decongestant ingredients in Sec. 341.80(b) should be used.
    (7) Other allowable statements. In addition to the required 
information identified in paragraph (b) of this section, the labeling of 
the combination drug product may contain any of the ``other allowable 
statements'' (if any), that are identified in the applicable OTC drug 
monographs, provided such statements are neither placed in direct 
conjunction with information required to appear in the labeling nor 
occupy labeling space with greater prominence or conspicuousness than 
the required information.
    (c) Warnings. The labeling of the product states, under the heading 
``Warnings,'' the warning(s) for each ingredient in the combination, as 
established in the warnings sections of the applicable OTC drug 
monographs, unless otherwise stated in paragraph (c) of this section.
    (1) For permitted combinations containing an antitussive and an 
analgesic-antipyretic identified in Sec. 341.40(f), (g), (l), and (m). 
The labeling states the following warnings:
    (i) For products labeled only for adults. The following warning 
should be used instead of the warnings in Sec. 341.74(c)(1) and part 343 
of this chapter: ``Stop use and ask a doctor if [in bold type] [bullet] 
pain or cough gets worse or lasts more than 7 days [bullet] fever gets 
worse or lasts more than 3 days [bullet] redness or swelling is present 
[bullet] new symptoms occur [bullet] cough comes back or occurs with 
rash or headache that lasts. These could be signs of a serious 
condition.''
    (ii) For products labeled only for children under 12 years of age. 
The following warning should be used instead of the warnings in 
Sec. 341.74(c)(3) and part 343 of this chapter: ``Stop use and ask a 
doctor if [in bold type] [bullet] pain or cough gets worse or lasts more 
than 5 days [bullet] fever gets worse or lasts more than 3 days [bullet] 
redness or swelling is present [bullet] new symptoms occur [bullet] 
cough comes back or occurs with rash or headache that lasts. These could 
be signs of a serious condition.''
    (iii) For products labeled for both adults and for children under 12 
years of age. The following warning should be used instead of the 
warnings in Sec. 341.74(c)(2) and part 343 of this chapter: ``Stop use 
and ask a doctor if [in bold type] [bullet] pain or cough gets worse or 
lasts more than 5 days (children) or 7 days (adults) [bullet] fever gets 
worse or lasts more than 3 days [bullet] redness or swelling is present 
[bullet] new symptoms occur [bullet] cough comes back or occurs with 
rash or headache that lasts. These could be signs of a serious 
condition.''
    (2) For permitted combinations containing an expectorant and an 
analgesic-antipyretic identified in Sec. 341.40(o). The labeling states 
the following warnings:
    (i) For products labeled only for adults. The warning in paragraph 
(c)(1)(i) of this section should be used instead of the warnings in 
Sec. 341.78(c)(3) and part 343 of this chapter.
    (ii) For products labeled only for children under 12 years of age. 
The warning in paragraph (c)(1)(ii) of this section

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should be used instead of the warnings in Sec. 341.78(c)(3) and part 343 
of this chapter.
    (iii) For products labeled for both adults and for children under 12 
years of age. The warning in paragraph (c)(1)(iii) of this section 
should be used instead of the warnings in Sec. 341.78(c)(3) and part 343 
of this chapter.
    (3) For permitted combinations containing a nasal decongestant and 
an analgesic-antipyretic identified in Sec. 341.40(c), (g), (m), (n), 
(q), and (r). The labeling states the following warnings:
    (i) For products labeled only for adults. The following warning 
should be used instead of the warnings in Sec. 341.80(c)(1)(i)(B) and 
part 343 of this chapter: ``Stop use and ask a doctor if [in bold type] 
[bullet] pain or nasal congestion gets worse or lasts more than 7 days 
[bullet] fever gets worse or lasts more than 3 days [bullet] redness or 
swelling is present [bullet] new symptoms occur''.
    (ii) For products labeled for only children under 12 years of age. 
The following warning should be used instead of the warnings in 
Sec. 341.80(c)(1)(ii)(B) and part 343 of this chapter: ``Stop use and 
ask a doctor if [in bold type] [bullet] pain or nasal congestion gets 
worse or lasts more than 5 days [bullet] fever gets worse or lasts more 
than 3 days [bullet] redness or swelling is present [bullet] new 
symptoms occur''.
    (iii) For products labeled for both adults and children under 12 
years of age. The following warning should be used instead of the 
warnings in Sec. 341.80(c)(1)(iii) and part 343 of this chapter: ``Stop 
use and ask a doctor if [in bold type] [bullet] pain or nasal congestion 
gets worse or lasts more than 5 days (children) or 7 days (adults) 
[bullet] fever gets worse or lasts more than 3 days [bullet] redness or 
swelling is present [bullet] new symptoms occur''.
    (4) For permitted combinations containing an antihistamine combined 
with an oral antitussive. The labeling states the warning ``When using 
this product [in bold type] [bullet] may cause marked drowsiness.'' The 
word ``marked'' may be deleted from the warning upon petition under the 
provisions of Sec. 10.30 of this chapter provided adequate data are 
submitted to demonstrate that the combination product does not cause a 
significant increase in drowsiness as compared with each active 
ingredient when tested alone. The petition and the data it contains will 
be maintained in a permanent file for public review in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.
    (5) For permitted combinations containing camphor, menthol, and 
eucalyptus oil identified in Sec. 341.40(u). The labeling states the 
warnings for topical antitussive ingredients in Sec. 341.74(c).
    (6) For permitted combinations containing levmetamfetamine with 
aromatics identified in Sec. 341.40(v). The labeling states the warnings 
for topical nasal decongestant ingredients in Sec. 341.80(c)(2).
    (d) Directions. The labeling of the product states, under the 
heading ``Directions,'' directions that conform to the directions 
established for each ingredient in the directions sections of the 
applicable OTC drug monographs, unless otherwise stated in paragraph (d) 
of this section. When the time intervals or age limitations for 
administration of the individual ingredients differ, the directions for 
the combination product may not exceed any maximum dosage limits 
established for the individual ingredients in the applicable OTC drug 
monograph.
    (1) For permitted combinations containing an anesthetic/analgesic 
and/or a demulcent in a liquid dosage form identified in Sec. 341.40(k), 
(s), (t), (w), (x), (y), (z), (aa), and (bb). The labeling states 
``[optional, bullet] gargle, swish around, or keep in the mouth for at 
least 1 minute and then swallow. Do not spit out.''
    (2) For permitted combinations containing camphor, menthol, and 
eucalyptus oil identified in Sec. 341.40(u). The labeling states the 
directions for topical antitussive ingredients in Sec. 341.74(d).
    (3) For permitted combinations containing levmetamfetamine with 
aromatics identified in Sec. 341.40(v). The labeling states the 
directions for topical nasal decongestant ingredients in 
Sec. 341.80(d)(2)(i) and (d)(2)(viii).

[67 FR 78170, Dec. 23, 2002]

    Effective Date Note: At 67 FR 78170, Dec. 23, 2002, Sec. 341.85 was 
added, effective Dec. 23, 2004.

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