Food and Drug Administration, HHS § 201.323
Food and Drug Administration, HHS § 201.323
§ 201.322 Over-the-counter drug prod- ‘‘Alcohol Warning’’ [heading in bold- ucts containing internal analgesic/ face type]: ‘‘If you consume 3 or more antipyretic active ingredients; re- alcoholic drinks every day, ask your quired alcohol warning. doctor whether you should take [insert (a) People who regularly consume acetaminophen and one nonsteroidal large quantities of alcohol (three or anti-inflammatory analgesic/anti- more drinks every day) have an in- pyretic active ingredient—including, creased risk of adverse effects (possible but not limited to aspirin, carbaspirin liver damage or gastrointestinal bleed- calcium, choline salicylate, magnesium ing). OTC drug products containing in- salicylate, or sodium salicylate] or ternal analgesic/antipyretic active in- other pain relievers/fever reducers. [Ac- gredients may cause similar adverse ef- etaminophen and (insert one nonste- fects. FDA concludes that the labeling roidal anti-inflammatory analgesic/ of OTC drug products containing inter- antipyretic ingredient—including, but nal analgesic/antipyretic active ingre- not limited to aspirin, carbaspirin cal- dients should advise consumers with a cium, choline salicylate, magnesium history of heavy alcohol use to consult salicylate, or sodium salicylate] may a physician. Accordingly, any OTC cause liver damage and stomach bleed- drug product, labeled for adult use, ing.’’ containing any internal analgesic/anti- (b) Requirements to supplement ap- pyretic active ingredients (including, proved application. Holders of approved but not limited to, acetaminophen, as- applications for OTC drug products pirin, carbaspirin calcium, choline sa- that contain internal analgesic/anti- licylate, ibuprofen, ketoprofen, magne- pyretic active ingredients that are sub- sium salicylate, naproxen sodium, and ject to the requirements of paragraph sodium salicylate) alone or in combina- (a) of this section must submit supple- tion shall bear an alcohol warning ments under § 314.70(c) of this chapter statement in its labeling as follows: to include the required warning in the (1) Acetaminophen. ‘‘Alcohol Warn- product’s labeling. Such labeling may ing’’ [heading in boldface type]: ‘‘If you be put into use without advance ap- consume 3 or more alcoholic drinks proval of FDA provided it includes the every day, ask your doctor whether exact information included in para- you should take acetaminophen or graph (a) of this section. other pain relievers/fever reducers. Ac- (c) Any drug product subject to this etaminophen may cause liver damage.’’ section that is not labeled as required (2) Nonsteroidal anti-inflammatory an- and that is initially introduced or ini- algesic/antipyretic active ingredients—in- tially delivered for introduction into cluding but not limited to aspirin, interstate commerce after April 23, carbaspirin calcium, choline salicylate, 1999, is misbranded under section 502 of ibuprofen, ketoprofen, magnesium salicy- the Federal Food, Drug, and Cosmetic late, naproxen sodium, and sodium salicy- Act (21 U.S.C. 352) and is subject to reg- late. ‘‘Alcohol Warning’’ [heading in ulatory action. boldface type]: ‘‘If you consume 3 or more alcoholic drinks every day, ask [63 FR 56801, Oct. 23, 1998] your doctor whether you should take [insert one nonsteroidal anti-inflam- § 201.323 Aluminum in large and small matory analgesic/antipyretic active in- volume parenterals used in total parenteral nutrition. gredient] or other pain relievers/fever reducers. [Insert one nonsteroidal anti- (a) The aluminum content of large inflammatory analgesic/antipyretic ac- volume parenteral (LVP) drug products tive ingredient] may cause stomach used in total parenteral nutrition bleeding.’’ (TPN) therapy must not exceed 25 (3) Combinations of acetaminophen with micrograms per liter (µg/L). nonsteroidal anti-inflammatory analgesic/ (b) The package insert of LVP’s used antipyretic active ingredients—including in TPN therapy must state that the but not limited to aspirin, carbaspirin cal- drug product contains no more than 25 cium, choline salicylate, ibuprofen, µg/L of aluminum. This information ketoprofen, magnesium salicylate, must be contained in the ‘‘Pre- naproxen sodium, and sodium salicylate. cautions’’ section of the labeling of all
69
VerDate 18