With flu shots now available across the country, and consumers stocking home medicine cabinets ahead of the coming cold and flu season, the Acetaminophen Awareness Coalition has issued a consumer message to “Double Check, Don’t Double Up” on acetaminophen when treating winter illnesses.

The Consumer Healthcare Products Association (CHPA) has filed a citizen petition to FDA that asks the agency to provide convenient and accurate access to dosing information for children ages six months to two years.

FDA has issued a Consumer Update that warns of rare but serious skin reactions that may occur in patients taking acetaminophen.

In a study recently published by the Journal of Pediatrics, researchers concluded that flow regulators for liquid medication bottles are an effective way to limit the amount of medication administered to young children. 

FDA is alerting consumers to be mindful of the amount of acetaminophen they take in order to prevent overdose and potential liver damage. 

One lot of Rugby Laboratories enteric coated aspirin tablets, 81 mg, has been recalled to the user level. 

A ruling by Judge Edward R. Korman, Eastern District Court of New York, will effectively make the Plan B® One-Step, or “morning after” contraceptive pill, available as an over-the-counter product with no age restrictions.

With the arrival of allergy season, FDA has a released a new video to help educate patients about safe use of medications containing acetaminophen.

The National Institutes of Health (NIH) has launched a free searchable database with information on prescription and over-the-counter drugs, herbals, and dietary supplements associated with liver injury. The LiverTox database is a free resource for health care providers and researchers...

Healthy People Co expanded a voluntary nationwide recall of dietary supplements sold under certain brand names for products bought on or before October 25, 2011, indicates a press release on the FDA Web site. Healthy People Co initiated a voluntary...

McNeil Consumer Healthcare has recalled seven lots of Infants’ Tylenol® Oral Suspension, 1 oz. Grape due to consumer complaints regarding difficulty in using the Infants’ Tylenol SimpleMeasureTM dosing system. McNeil explains that in some cases the protective cover, or “flow...

FDA reminds consumers using over-the-counter (OTC) asthma inhalers containing chlorofluorocarbons (CFCs) that the products will no longer be made or sold after December 31, 2011. Consumers should plan now to obtain a prescription for a replacement product, FDA advises. The...

A new video from Food and Drug Administration (FDA) seeks to educate consumers on how to use the drug facts labels provided on over-the-counter (OTC) medications. The video introduces and explains the importance of each section of the OTC Drug...

In the interest of patient safety, the National Council for Prescription Drug Programs (NCPDP) has published a white paper providing recommendations to industry intended to facilitate consistency in labels for both over-the-counter (OTC) and prescription products containing acetaminophen. The paper,...

To decrease the potential for accidental overdose, McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. has announced that single-ingredient Extra Strength Tylenol® (acetaminophen) products sold in the US will include new dosing instructions beginning in fall 2011. The new dosing instructions...

Food and Drug Administration (FDA), in partnership with the Federal Trade Commission, has taken action against over-the-counter (OTC) products marketed as treatments, cures, and for prevention of sexually transmitted diseases (STDs). The agencies have sent letters to companies making such...

To help prevent acetaminophen overdose in infants and children, drug manufacturers will begin distributing a single concentration OTC pain reliever for pediatric use. Current formulations in different concentrations for infants and for older children have caused some confusion among parents...

To address concerns about the risk of accidental overdoses with OTC medications, especially in children, FDA has released a final draft guidance for industry regarding the manufacture of dosage delivery devices. The document “Guidance for Industry Dosage Delivery Devices for...

United States Pharmacopeial Convention (USP) will partner with Food and Drug Administration (FDA) and the Consumer Healthcare Products Association to update quality standards for widely used medications and ingredients. So that test procedures will be revised as needed to reflect...

McNeil Consumer Healthcare has voluntarily recalled, at the wholesale level, certain lots of Tylenol® 8 Hour, Tylenol® Arthritis Pain, and Tylenol® upper respiratory products, and certain lots of Benadryl®, Sudafed PE®, and Sinutab® products distributed in the United States, the...

FDA released a Guidance for Industry, “Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use – Small Entity Compliance Guide” (PDF) on August 17, 2010 to help small businesses understand and comply with FDA’s organ-specific labeling...

McNeil Consumer Healthcare has initiated a voluntary recall of certain over-the-counter (OTC) liquid products for children and infants due to manufacturing deficiencies which may affect quality, purity, or potency, as explained in an FDA News Release. Tylenol®, Motrin®, Zyrtec®, and...

When selecting over-the-counter (OTC) medications, 82% of pharmacy customers base their decision on a pharmacist’s recommendation, according to a survey (PDF) of over 1,000 pharmacists conducted by the American Pharmacists Association (APhA). Survey results, presented in the Pharmacy Today Over-the-Counter Supplement,...

Reprinted from the April 2008 North Carolina Board of Pharmacy Newsletter. North Carolina Board of Pharmacy staff periodically receives questions about the compounding of over-the-counter (OTC) products. Compounding of OTC products can involve at least two scenarios. First, a pharmacist...

Published in the February 2007 Alabama State Board of Pharmacy Newsletter The United States Food and Drug Administration approved Plan B® for sale to customers 18 years of age or older without a prescription in August 2006. Distribution of the...

Reprinted from the January 2007 Montana Board of Pharmacy Newsletter. The August 24, 2006, FDA approval of the over-the-counter (OTC) sale of Plan B® to women 18 years of age and older was intended to make the drug more easily...

Reprinted from the January 2007 Nevada State Board of Pharmacy Newsletter. 1. Plan B®: On August 24, 2006, FDA approved Plan B for over-the-counter (OTC) sale. Please note the following: a. Plan B is authorized for OTC sale in pharmacies...

Reprinted from the July 2006 Minnesota Board of Pharmacy Newsletter. The federal Combat Methamphetamine Epidemic Act of 2005 was signed into law on March 9, 2006. Parts of this law are at odds with a state law enacted by the...

Reprinted from the April 2006 Minnesota Board of Pharmacy Newsletter. In 2005, Minnesota joined the ranks of states that have placed additional restrictions on the methamphetamine precursor drugs ephedrine and pseudoephedrine. Most products containing these drugs, either alone or in...

Published in the January 2006 Washington State Board of Pharmacy Newsletter By William O. Robertson, MD, Medical Director, Washington Poison Center When Poison Centers first appeared in the mid-1950s, they focused almost exclusively on the problems of children who took...