Navigation Links
FDA Issues Final Guidance for Liquid OTC Drug Products With Dispensing Devices
Date:5/4/2011

SILVER SPRING, Md., May 4, 2011/PRNewswire-USNewswire/ --The U.S. Food and Drug Administration today released its final guidance to firms that manufacture, market, or distribute over-the-counter (OTC) liquid drug products packaged with cups, droppers, syringes, and spoons to measure and dispense the doses of medication.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

The guidance, titled Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products, describes how easy-to-use dosage delivery devices and devices that minimize the risk of unintentional overdose can be provided for OTC medicines such as liquid pain relievers, cold medicine, cough syrups, and digestion aids.

"Accidental medication overdose in young children is an increasingly common, but preventable public health problem," said Karen Weiss, M.D., program director for the Center for Drug Evaluation and Research's Safe Use Initiative.

The FDA issued the guidance because of ongoing concerns about the potential accidental drug overdoses that can result from the use of dosage delivery devices with markings that are confusing, unclear or inconsistent with the labeled dosage directions.

Key recommendations in the guidance include:

  • Dosage delivery devices should be included for all orally ingested OTC liquid drug products
  • Devices should be marked with calibrated units of liquid measurement (e.g., teaspoon, tablespoon, or milliliter) that are the same as the units of liquid measure specified in the directions for the product and there should not be any unnecessary markings
  • Manufacturers should ensure that dosage delivery devices are used only with the products they are packaged with
  • Liquid measure markings on dosage delivery devices should be clearly visible and not obscured when the liquid product is added to the device. '/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Dehaier Medical Chairman and CEO Issues Letter to Shareholders
2. Omni Bio Pharmaceutical, Incs. CEO Issues Letter to Shareholders
3. The Centers For Medicare and Medicaid Services Issues Advance Guidance to Part D Plan Sponsors Allowing the Use of Generic Sampling as Medicare Part D Drug Utilization Management Tool.
4. New FDLIs Food and Drug Policy Forum Focuses on Liability Issues in Vaccine Design Defect Claims
5. UBM TechInsights Issues Warning to Medical Devices Industry About Possible Obsolescence as Reliance on Smartphones Increases
6. Qualitest Pharmaceuticals Issues Voluntary, Nationwide Recall of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg / 500 mg, NDC 0603-3888-20, 60 Count, Lot Numbers T150G10B, T120J10E and T023M10A and Phenobarbital Tablets, USP 32.4 mg, ND
7. Viral Genetics Issues 2010 Year in Review, 2011 Outlook
8. S&P Equity Research Issues Health Care Sector Predictions for 2011
9. FDA Issues Complete Response Letter Regarding Acetadote® Supplemental New Drug Application for Acute Liver Failure
10. Extreme Makeover for Healthcare Next Year? PwC Publishes its Top Health Industry Issues for 2011
11. Dr. Paul Janssen Award for Biomedical Research Issues Call for Nominations
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... SANTA BARBARA, Calif. , Dec. 23, 2014 ... the Junior Doctors, Association of Sierra Leone ... Sierra Leone for the treatment of local ... While a new dedicated Ebola care center was ... Ebola virus, the facility is not available for local Sierra ...
(Date:12/22/2014)... 22, 2014 NxStage Medical, Inc. (NASDAQ: ... dialysis products, announced today that the U.S. Food ... One™ to perform hemodialysis overnight while the patient ... hemodialysis. NxStage,s® System One is the first and ... this indication. Home nocturnal hemodialysis ...
(Date:12/22/2014)... DUBLIN , Dec. 22, 2014 Research ... announced the addition of the "Investment Analysis ... report to their offering. ... investments in the US medical device sector identifies ... equity and venture capital investments, and mergers and ...
Breaking Medicine Technology:First Ebola Treatment Unit for Local Health Workers Arrives in Sierra Leone 2NxStage Receives FDA Clearance for Home Nocturnal Hemodialysis 2NxStage Receives FDA Clearance for Home Nocturnal Hemodialysis 3Investment Analysis of the US Medical Device Sector 2
... REDWOOD CITY, Calif., May 18, 2011 Genomic Health, ... the company will present results from ten separate studies ... Meeting, taking place June 3-7, 2011 at McCormick Place ... DX® breast cancer test, which is clinically validated ...
... Dendreon Corporation (Nasdaq: DNDN ) today ... at the 2011 American Society of Clinical Oncology annual ... to Disease-Related Pain After Sipuleucel-T in Asymptomatic Patients with ... Phase 3 Trials," abstract #4661. McCormick Place Hall A ...
Cached Medicine Technology:Genomic Health Announces Ten Studies Covering Breast, Colon and Prostate Cancers Accepted for Presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 2Genomic Health Announces Ten Studies Covering Breast, Colon and Prostate Cancers Accepted for Presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 3Genomic Health Announces Ten Studies Covering Breast, Colon and Prostate Cancers Accepted for Presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 4Genomic Health Announces Ten Studies Covering Breast, Colon and Prostate Cancers Accepted for Presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 5Genomic Health Announces Ten Studies Covering Breast, Colon and Prostate Cancers Accepted for Presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 6Genomic Health Announces Ten Studies Covering Breast, Colon and Prostate Cancers Accepted for Presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 7Dendreon Announces Presentation of PROVENGE Data at the 2011 American Society of Clinical Oncology Annual Meeting 2Dendreon Announces Presentation of PROVENGE Data at the 2011 American Society of Clinical Oncology Annual Meeting 3Dendreon Announces Presentation of PROVENGE Data at the 2011 American Society of Clinical Oncology Annual Meeting 4
(Date:12/26/2014)... 2014 Parker & Sons, Inc. ... in heating, cooling and plumbing contractor services throughout ... services in 2014 with regard to air-conditioning systems. ... is known for its incredibly hot summers. Working ... intricacies and details of a wide variety of ...
(Date:12/25/2014)... 2014 The click strand ... strength and durability. Today, the business announces a ... valid until Jan. 30, 2015. , Click strand ... hardwood. BambooFlooringChina.com is a well-known brand in the ... to find a reliable bamboo flooring supplier. , ...
(Date:12/25/2014)... 2014 Product liability lawsuits filed in ... ( http://www.consumerinjurylawyers.com/DePuy/ ) continue to move forward in federal ... issued in the U.S. District Court, Northern District of ... open conference on January 7, 2015, at the Paul ... West Palm Beach, Florida. The Conference is scheduled to ...
(Date:12/25/2014)... Recently, Dylan Queen, a famous online company supplying ... of discounted prom dresses, most of which are priced ... the company, the promotion is valid until Jan. 22, ... the UK market. , The prom dresses in this ... styles: A-line strapless, empire strapless chiffon, one shoulder, floor-length, ...
(Date:12/25/2014)... sells many bamboo products and the business is famous ... announces big discounts on its bamboo mats , which ... the world’s leader in bamboo flooring. According to the ... 2015. , The bamboo mats are made from well-treated ... the bamboo strips for the mats are boiled and ...
Breaking Medicine News(10 mins):Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 2Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 3Health News:BambooFlooringChina.com: click strand woven bamboo flooring promotion valid until Jan. 30, 2015. 2Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 2Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 3Health News:Dylan Queen: Cheap Prom Dresses for the UK Market 2Health News:Various Styles of Bamboo Mats in Many Colors from BambooFlooringChina.com 2
... among people who have mild memory loss, and they can ... largest ever investigation into heart disease and stroke in those ... some of who had a MRI scan which could indicate ... at Wake Forest University now report on this sub-group, observing ...
... been at a loss when it comes to health issues. ... tobacco smoke for residents. Environmental tobacco smoke// (ETS, or passive ... - from exacerbation of asthma to eye irritation and even ... workplace and in public places. Researchers at the University of ...
... new study, researchers found that the treatment naltrexone is ... abuse. Researchers of alcohol often distinguish two patterns of ... drinking are saved up for the weekend and holidays, ... regularly and often with meals. The Anglo-Saxon pattern has ...
... new study, children of people with mood disorders who have ... own lives as well. The link is especially strong among ... who suffer from mood disorders themselves. ,Research has shown ... risk of committing suicide, but few studies have looked at ...
... they have observed that postmenopausal women who use estrogen are ... tissue change in the joints that causes pain in that ... over 40 years old. Experts estimate up to 70 percent ... conducted a study to see if estrogen plays a role ...
... a clot-buster injection may unclog a mechanical heart pump, ... from University Hospital in Germany,// felt that this is ... heart failure patients who receive left ventricular assist devices. ... pump-like device that is surgically implanted to maintain the ...
Cached Medicine News:
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: