[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: 21CFR201.70]
[Page 53]
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. 201.70 Calcium labeling.
(a) The labeling of over-the-counter (OTC) drug products intended
for oral ingestion shall contain the calcium content per dosage unit
(e.g., tablet, teaspoonful) if the calcium content of a single maximum
recommended dose of the product (which may be one or more dosage units)
is 20 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 calcium content shall be expressed in milligrams or grams
per dosage unit and shall include the total amount of calcium regardless
of the source, i.e., from both active and inactive ingredients. If the
dosage unit contains less than 1 gram of calcium, milligrams should be
used. The calcium content per dosage unit shall be rounded-off to the
nearest 5 milligrams (or nearest tenth of a gram if over 1 gram). The
calcium 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 calcium present in the labeled maximum daily dose of the
product is more than 3.2 grams: ``Ask a doctor before use if you have
[in bold type] [bullet]\1\ kidney stones [bullet] a calcium-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) 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 drug marketing applications approved before April 23, 2004.
[69 FR 13733, Mar. 24, 2004]
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