Search Results for Acetaminophen

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FDA Issues Labeling Guidance for Aspirin, Acetaminophen By Michael Mezher - Published 10 January 2017

The US Food and Drug Administration (FDA) on Tuesday issued one draft guidance recommending a label advisory for over-the-counter (OTC) products containing aspirin, and finalized another recommending a warning label for OTC acetaminophen-containing products.

Categories: News, US, FDA, Over the counter drugs, Labeling, Packaging

Tags: Aspirin, Acetaminophen

FDA Amends Liver Warning Labeling Guidance for Some OTC Drugs Containing Acetaminophen By Zachary Brennan - Published 16 November 2015

The US Food and Drug Administration (FDA) on Monday unveiled amended guidance on the liver warnings that must be contained in labels of over-the-counter (OTC) drugs containing acetaminophen, saying it will allow manufacturers in some cases to warn patients against taking more than 4,000 mg of acetaminophen in 24 hours.

Categories: News, US, FDA, Drugs, Government affairs, Labeling, Packaging, Regulatory intelligence, Regulatory strategy

Tags: Acetaminophen, Tylenol, liver warning, liver damage, OTC, FDA labeling guidance

FDA Orders New Warnings on OTC Acetaminophen Drugs By Alexander Gaffney, RAC - Published 01 December 2014

A new draft guidance document issued by the US Food and Drug Administration (FDA) calls for all over-the-counter (OTC) drugs containing acetaminophen to be labeled with a new statement warning consumers about the risk of the products causing serious skin reactions.

Categories: News, CDER, Over the counter drugs, Postmarket surveillance

Tags: Acetaminophen, Draft Guidance, Labeling, Warning, Skin Reactions

Three Years After Warnings, FDA Bans Last High-Dose Aceptaminophen Products By Alexander Gaffney, RAC - Published 16 July 2014

All prescription drugs containing high doses of acetaminophen have officially been withdrawn from the market, the US Food and Drug Administration (FDA) indicated in a regulatory filing this morning.

Categories: News, US, CDER, Drugs, Product withdrawl and retirement

Tags: Acetaminophen, Withdrawal, Removal, 325 mg Acetaminophen

FDA Issues New Draft Guidance for Products Containing Acetaminophen By Alexander Gaffney - Published 03 July 2012

Categories: FDA

Tags: Latest News, label, acetaminophen, draft guidance