ACETAMINOPHEN | N019872 | KENVUE BRANDS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Jonathan Smith FDA-2022-P-0215 Jonathan Smith and other healthcare providers specializing in neurology, headache medicine, and otorhinolaryngology filed this citizen petition requesting that the FDA require manufacturers to revise over-the-counter product labeling that associates the terms "sinus" and "headache" (such as Tylenol | Other | 2022-02-25 | Denied | Jonathan Smith |
Citizen Petition from GlaxoSmithKline Consumer Healthcare (GSKCH) FDA-1977-N-0013 GlaxoSmithKline Consumer Healthcare filed this citizen petition under 21 CFR 10.30 and 330.10 requesting that the FDA require an allergy warning in the "Do Not Use" section of Drug Facts labels for all over-the-counter acetaminophen products, and either issue a direct final rule or amend the Tentati | Other | 2017-07-17 | Open | GlaxoSmithKline Consumer Healthcare (GSKCH) |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2015-P-1153 Lachman Consultant Services, Inc. filed this petition under 21 CFR 10.30 and 314.161, requesting that the FDA determine whether Tylenol with Codeine Tablets (acetaminophen with codeine phosphate) in strengths of 325 mg/7.5 mg, 325 mg/15 mg, 325 mg/30 mg, and 325 mg/60 mg were voluntarily withdrawn f | 505(q) | 2015-04-10 | Granted | Lachman Consultant Services, Inc. |
Citizen Petition from GlaxoSmithKline Consumer Healthcare FDA-1977-N-0013 GlaxoSmithKline Consumer Healthcare filed this citizen petition on March 14, 2011, requesting that the FDA maintain the current over-the-counter availability of acetaminophen at a 1,000 mg single adult dose under the Tentative Final Monograph for Internal Analgesic, Antipyretic and Antirheumatic Dru | Other | 2011-03-24 | Open | GlaxoSmithKline Consumer Healthcare |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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