Search Results for Aspirin

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FDA: Aspirin Manufacturers' Cardio Imagery is OK if Label Statement Included By Zachary Brennan - Published 06 November 2017

The US Food and Drug Administration (FDA) on Monday said that it does not intend to take action against certain manufacturers of over-the-counter (OTC) aspirin products because the label includes cardiovascular-related imagery (e.g., heart image, electrocardiography graphic, stethoscope around a heart image) if the label also includes language as described in guidance finalized Monday.

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

Tags: aspirin, FDA label, cardiovascular images

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The US Food and Drug Administration (FDA) on Tuesday issued one draft guidance recommending a label advisory for over-the-counter (OTC) products containing aspirin, and finalized another recommending a warning label for OTC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

Aspirin-Containing Heartburn Drugs: FDA Warns of Serious Bleeding Risk By Zachary Brennan - Published 06 June 2016

The US Food and Drug Administration (FDA) on Monday warned consumers about the risk of serious bleeding when using over-the-counter (OTC) aspirin-containing antacid drugs to treat heartburn, sour stomach, acid indigestion or upset stomach.

Categories: News, US, FDA, Over the counter drugs, Postmarket surveillance

Tags: aspirin, heartburn, OTC drug safety communications, nonprescription drugs

Canada: New Safety Labeling Guidance for Aspirin Products By Ansis Helmanis, RegLink - Published 31 July 2012

Categories: Regulatory Update, Health Canada

Tags: Draft Regulation, ASA, Aspirin

EMA Looks to Open Up Clinical Trial Data After Concerns About Tamiflu Raised By Alexander Gaffney - Published 11 April 2012

Categories: EMA

Tags: Aspirin, PLoS Medicine, Eichler, Tamiflu, Abadie, Rasi, PLoS, Flu, Journal, Roche, Latest News, clinical trial, data, regulatory