[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: 21CFR201.64]
[Page 43-44]
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. 201.64 Sodium labeling.
(a) The labeling of over-the-counter (OTC) drug products intended
for oral ingestion shall contain the sodium content per dosage unit
(e.g., tablet, teaspoonful) if the sodium content of a single maximum
recommended dose of the product (which may be one or more dosage units)
is 5 milligrams or more. OTC drug products intended for oral ingestion
include gum and lozenge dosage forms, but do not include dentifrices,
mouthwashes, or mouth rinses.
(b) The sodium content shall be expressed in milligrams per dosage
unit and shall include the total amount of sodium regardless of the
source, i.e., from both active and inactive ingredients. The sodium
content shall be rounded-off to the nearest whole number. The sodium
content per dosage unit shall follow the heading ``Other information''
as stated in Sec. 201.66(c)(7).
(c) The labeling of OTC drug products intended for oral ingestion
shall contain the following statement under the heading ``Warning'' (or
``Warnings'' if it appears with additional warning statements) if the
amount of sodium present in the labeled maximum daily dose of the
product is more than 140 milligrams: ``Ask a doctor before use if you
have [in bold type] [bullet]\1\ a sodium-restricted diet''. The warnings
in Sec. Sec. 201.64(c), 201.70(c), 201.71(c), and 201.72(c) may be
combined, if applicable, provided the ingredients are listed in
alphabetical order, e g., a calcium or sodium restricted diet.
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\1\ See Sec. 201 .66(b)(4) of this chapter for definition of bullet
symbol.
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(d) The term sodium free may be used in the labeling of OTC drug
products intended for oral ingestion if the amount of sodium in the
labeled maximum daily dose is 5 milligrams or less and the amount of
sodium per dosage unit is 0 milligram (when rounded-off in accord with
paragraph (b) of this section).
(e) The term very low sodium may be used in the labeling of OTC drug
products intended for oral ingestion if the amount of sodium in the
labeled maximum daily dose is 35 milligrams or less.
(f) The term low sodium may be used in the labeling of OTC drug
products intended for oral ingestion if the amount of sodium in the
labeled maximum daily dose is 140 milligrams or less.
(g) The term salt is not synonymous with the term sodium and shall
not be used interchangeably or substituted for the term sodium.
(h) The terms sodium free, very low sodium, and low sodium shall be
in print size and style no larger than the product's statement of
identity and shall not be unduly prominent in print size or style
compared to the statement of identity.
(i) Any product subject to this paragraph that contains sodium
bicarbonate, sodium phosphate, or sodium biphosphate as an active
ingredient for oral ingestion and that is not labeled as required by
this paragraph and that is initially introduced or initially delivered
for introduction into interstate commerce after April 22, 1997, is
misbranded under sections 201(n) and 502 (a) and (f) of the Federal
Food, Drug, and Cosmetic Act (the act).
[[Page 44]]
(j) Any product subject to paragraphs (a) through (h) of this
section that is not labeled as required 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.
(1) As of the date of approval of the application for any single
entity and combination products subject to drug marketing applications
approved on or after April 23, 2004.
(2) Septemeber 24, 2005, for all OTC drug products subject to any
OTC drug monograph, not yet the subject of any OTC drug monograph, or
subject to drug marketing applications approved before April 23, 2004.
(k) The labeling of OTC drug products intended for rectal
administration containing dibasic sodium phosphate and/or monobasic
sodium phosphate shall contain the sodium content per delivered dose if
the sodium content is 5 milligrams or more. The sodium content shall be
expressed in milligrams or grams. If less than 1 gram, milligrams should
be used. The sodium content shall be rounded-off to the nearest whole
number if expressed in milligrams (or nearest tenth of a gram if
expressed in grams). The sodium content per delivered dose shall follow
the heading ``Other information'' as stated in Sec. 201.66(c)(7). Any
product subject to this paragraph that contains dibasic sodium phosphate
and/or monobasic sodium phosphate as an active ingredient intended for
rectal administration and that is not labeled as required by this
paragraph and that is initially introduced or initially delivered for
introduction into interstate commerce after November 29, 2005, is
misbranded under sections 201(n) and 502(a) and (f) of the act.
[61 FR 17806, Apr. 22, 1996, as amended at 62 FR 19925, Apr. 24, 1997;
64 FR 13286, Mar. 17, 1999; 69 FR 13724, Mar. 24, 2004; 69 FR 69280,
Nov. 29, 2004]
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