[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: 21CFR201.307]
[Page 80-81]
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. 201.307 Sodium phosphates; package size limitation, warnings, and
directions for over-the-counter sale.
(a) Reports in the medical literature and data accumulated by the
Food and Drug Administration indicate that multiple container sizes of
sodium phosphates oral solution available in the marketplace have caused
consumer confusion and appear to have been involved in several consumer
deaths. Sodium phosphates oral solution has been marketed in 45-
milliliter (mL), 90-mL, and 240-mL container sizes. The 45-mL and 90-mL
container sizes of sodium phosphates oral solution are often recommended
and prescribed by physicians for bowel cleansing prior to surgery and
diagnostic procedures of the colon. Sodium phosphates oral solution
(adult dose 20 mL to 45 mL) is also used as an over-the-counter (OTC)
laxative for the relief of occasional constipation. Accidental
overdosing and deaths have occurred because the 240-mL container was
mistakenly used instead of the 45-mL or 90-mL container. The Food and
Drug Administration is limiting the amount of sodium phosphates oral
solution to not more than 90 mL (3 ounces (oz)) per OTC container
because of the serious health risks associated with the ingestion of
larger than intended doses of this product. Further, because an overdose
of either oral or rectal enema sodium phosphates can cause an
electrolyte imbalance, additional warning and direction statements are
required for the safe use of any OTC laxative drug product containing
sodium phosphates.
(b) Any OTC drug product for laxative or bowel cleansing use
containing sodium phosphates as an active ingredient when marketed as
described in paragraph (a) of this section is misbranded within the
meaning of section 502 of the Federal Food, Drug, and Cosmetic Act
unless packaged and labeled as follows:
(1) Package size limitation for sodium phosphates oral solution:
Container shall not contain more than 90 mL (3 oz).
(2) Warnings. The following sentences shall appear in boldface type
as the first statement under the heading ``Warnings.''
(i) Oral dosage forms. ``Taking more than the recommended dose in 24
hours can be harmful.''
(ii) Rectal enema dosage forms. ``Using more than one enema in 24
hours can be harmful.''
(3) Directions--(i) The labeling of all orally or rectally
administered OTC drug products containing sodium phosphates shall
contain the following directions in boldface type immediately preceding
the dosage information: ``Do not'' (``take'' or ``use'') ``more unless
directed by a doctor. See Warnings.''
(ii) For products containing dibasic sodium phosphate/monobasic
sodium phosphate identified in Sec. 334.16(d) marketed as a solution.
Adults and children 12 years of age and over: Oral dosage is dibasic
sodium phosphate 3.42 to 7.56 grams (g) and monobasic sodium phosphate
9.1 to 20.2 g (20 to 45 mL dibasic sodium phosphate/monobasic sodium
phosphate oral solution) as a single daily dose. ``Do not take more than
45 mL (9 teaspoonfuls or 3 tablespoonfuls) in a 24-hour period.''
Children 10 and 11 years of age: Oral dosage is dibasic sodium phosphate
1.71 to 3.78 g and monobasic sodium phosphate 4.5 to 10.1 g (10 to 20 mL
dibasic sodium phosphate/monobasic sodium phosphate oral solution) as a
single daily dose. ``Do not take more than 20 mL (4 teaspoonfuls) in a
24-hour period.'' Children 5 to 9 years of age: Oral dosage is dibasic
sodium phosphate 0.86 to 1.89 g and monobasic sodium phosphate 2.2 to
5.05 g (5 to 10 mL dibasic sodium phosphate/monobasic sodium phosphate
oral solution) as a single daily dose. ``Do not take more than 10 mL (2
teaspoonfuls) in a 24-hour period.'' Children under 5 years of age: ask
a doctor.
(c) After June 22, 1998, for package size limitation and September
18, 1998, for labeling in accord with paragraph (b) of this section, any
such OTC drug product initially introduced or initially delivered for
introduction into interstate commerce, or any such drug product that is
repackaged or relabeled
[[Page 81]]
after these dates regardless of the date the product was manufactured,
initially introduced, or initially delivered for introduction into
interstate commerce, that is not in compliance with this section is
subject to regulatory action.
[63 FR 27843, May 21, 1998]
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