[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: 21CFR201.322]
[Page 87-88]
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. 201.322 Over-the-counter drug products containing internal
analgesic/antipyretic active ingredients; required alcohol warning.
(a) People who regularly consume large quantities of alcohol (three
or more drinks every day) have an increased risk of adverse effects
(possible liver damage or gastrointestinal bleeding). OTC drug products
containing internal analgesic/antipyretic active ingredients may cause
similar adverse effects. FDA concludes that the labeling of OTC drug
products containing internal analgesic/antipyretic active ingredients
should advise consumers with a history of heavy alcohol use to consult a
physician. Accordingly, any OTC drug product, labeled for adult use,
containing any internal analgesic/antipyretic active ingredients
(including, but not limited to, acetaminophen, aspirin, carbaspirin
calcium, choline salicylate, ibuprofen, ketoprofen, magnesium
salicylate, naproxen sodium, and
[[Page 88]]
sodium salicylate) alone or in combination shall bear an alcohol warning
statement in its labeling as follows:
(1) Acetaminophen. ``Alcohol Warning'' [heading in boldface type]:
``If you consume 3 or more alcoholic drinks every day, ask your doctor
whether you should take acetaminophen or other pain relievers/fever
reducers. Acetaminophen may cause liver damage.''
(2) Nonsteroidal anti-inflammatory analgesic/antipyretic active
ingredients--including but not limited to aspirin, carbaspirin calcium,
choline salicylate, ibuprofen, ketoprofen, magnesium salicylate,
naproxen sodium, and sodium salicylate. ``Alcohol Warning'' [heading in
boldface type]: ``If you consume 3 or more alcoholic drinks every day,
ask your doctor whether you should take [insert one nonsteroidal anti-
inflammatory analgesic/antipyretic active ingredient] or other pain
relievers/fever reducers. [Insert one nonsteroidal anti-inflammatory
analgesic/antipyretic active ingredient] may cause stomach bleeding.''
(3) Combinations of acetaminophen with nonsteroidal anti-
inflammatory analgesic/antipyretic active ingredients--including but not
limited to aspirin, carbaspirin calcium, choline salicylate, ibuprofen,
ketoprofen, magnesium salicylate, naproxen sodium, and sodium
salicylate. ``Alcohol Warning'' [heading in boldface type]: ``If you
consume 3 or more alcoholic drinks every day, ask your doctor whether
you should take [insert acetaminophen and one nonsteroidal anti-
inflammatory analgesic/antipyretic active ingredient--including, but not
limited to aspirin, carbaspirin calcium, choline salicylate, magnesium
salicylate, or sodium salicylate] or other pain relievers/fever
reducers. [Acetaminophen and (insert one nonsteroidal anti-inflammatory
analgesic/antipyretic ingredient--including, but not limited to aspirin,
carbaspirin calcium, choline salicylate, magnesium salicylate, or sodium
salicylate] may cause liver damage and stomach bleeding.''
(b) Requirements to supplement approved application. Holders of
approved applications for OTC drug products that contain internal
analgesic/antipyretic active ingredients that are subject to the
requirements of paragraph (a) of this section must submit supplements
under Sec. 314.70(c) of this chapter to include the required warning in
the product's labeling. Such labeling may be put into use without
advance approval of FDA provided it includes the exact information
included in paragraph (a) of this section.
(c) Any drug product subject to this section that is not labeled as
required and that is initially introduced or initially delivered for
introduction into interstate commerce after April 23, 1999, is
misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 352) and is subject to regulatory action.
[63 FR 56801, Oct. 23, 1998]
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