News tagged over-the-counter
USP Prescription Container Labeling Chapter is Now the Official Standard
The United States Pharmacopeia (USP) General Chapter <17> Prescription Container Labeling, published in the USP 36–NF 31, became an official standard on May 1, 2013.
FDA Releases New Consumer Video on Acetaminophen Safety
With the arrival of allergy season, FDA has a released a new video to help educate patients about safe use of medications containing acetaminophen.
NIH Database Provides Information on Drugs Associated With Liver Injury
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...
Read More →Voluntary Recall of Healthy People Co Dietary Supplements Expanded
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...
Read More →Seven Lots of Infants' Tylenol Oral Suspension Recalled Due to Dosing System Issue
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...
Read More →OTC Asthma Inhalers Containing CFCs Phased Out By Year End, Prescription Needed for Replacement Products
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...
Read More →FDA Video Shows Consumers How to Use OTC Drug Labels
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...
Read More →NCPDP White Paper Recommends Consistent Labeling for Prescription Acetaminophen Products to Promote Patient Safety
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,...
Read More →New Acetaminophen Dosing Instructions for OTC Products to Help Ensure Appropriate Use
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...
Read More →FDA Takes Action Against Fraudulent OTC Products
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...
Read More →Single Concentration OTC Pediatric Pain Relievers in Distribution Soon
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...
Read More →FDA Releases Final Guidance for OTC Dosage Delivery Devices
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...
Read More →USP to Update Quality Standards for Widely Used Medications
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...
Read More →McNeil Recalls Additional Over-the-Counter Products
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...
Read More →Industry Guidance Includes Latest Warning Information for OTC Analgesics, Antipyretics, and Antirheumatics
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...
Read More →Recall of OTC Liquid Medicines for Children and Infants
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...
Read More →Survey Suggests Majority of Patients Seek Pharmacist Advice About OTC Medications
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,...
Read More →North Carolina News: Item 2160 - Compounding OTC Products
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...
Read More →Alabama News: Plan B - Options in Alabama
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...
Read More →Montana News: OTC Plan B Raises Logistical and Administrative Challenges
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...
Read More →Nevada News: For Your Information
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...
Read More →Minnesota News: Methamphetamine Precursors - Another Update
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...
Read More →Minnesota News: Methamphetamine Precursors - An Update
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...
Read More →Washington News: Ongoing Controversy Re: Syrup of Ipecac
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...
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