[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: 21CFR201.72]
[Page 54-55]
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. 201.72 Potassium labeling.
(a) The labeling of over-the-counter (OTC) drug products intended
for oral ingestion shall contain the potassium content per dosage unit
(e.g., tablet, teaspoonful) if the potassium 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 potassium content shall be expressed in milligrams or grams
per dosage unit and shall include the total amount of potassium
regardless of the source, i.e., from both active and inactive
ingredients. If the dosage unit contains less than 1 gram of potassium,
milligrams should be used. The potassium content shall be rounded-off to
the nearest 5 milligrams (or nearest tenth of a gram if over 1 gram).
The potassium 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 potassium present in the labeled maximum daily dose of the
product is more than 975 milligrams: ``Ask a doctor before use if you
have [in bold type] [bullet]\1\ kidney disease [bullet] a potassium-
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 magnesium or
potassium-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) Any product subject to this paragraph that is not labeled as
required by this paragraph 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) September 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
[[Page 55]]
drug marketing applications approved before April 23, 2004.
[69 FR 13734, Mar. 24, 2004]
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