ProHealth health Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help
Facebook Google Plus
Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Lyme Disease  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

Curcumin: The All In One Solution, Part 2

What Are the Benefits of Vitamin K2?

Vitamin D deficiency + high fat diet = metabolic syndrome

Use Burdock Oil to Promote Healthy Hair Growth

Why You Should Take Your Apple Cider Vinegar at Night

AMA journal associates iron deficiency with hearing loss

Lutein linked to preservation of crystallized intelligence

People with forms of early-onset Parkinson's disease may benefit from boosting niacin in diet, resea...

Zinc eaten at levels found in biofortified crops reduces 'wear and tear' on DNA

A handful of nuts a day cuts the risk of a wide range of diseases

 
Print Page
Email Article

FDA requires additional labeling for over-the-counter pain relievers and fever reducers to help consumers use products safely

  [ 2 votes ]   [ Discuss This Article ]
By U.S. Food & Drug Administration • www.ProHealth.com • June 18, 2009


The labeling on these drugs must warn of the risks of stomach bleeding for NSAIDs (aspirin, ibuprofen, etc.) and severe liver damage for acetaminophen (Tylenol, paracetamol, etc.)

The Food and Drug Administration issued a final rule April 28, 2009 that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs.

Products covered by the FDA action include:

• Acetaminophen (Tylenol and other brands)

• And a class of drugs known as the nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs include
- Aspirin,
- Ibuprofen,
- Naproxen,
- And ketoprofen.

Acetaminophen is in a class by itself. The revised labeling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines containing pain relievers or fever reducers.

“Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches, “ said Charles Ganley, MD, director, FDA’s Office of Nonprescription Drugs in the Center for Drug Evaluation and Research.

“However, the risks associated with their use, need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk.”

• Under the final rule, manufacturers must ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both the packages and bottles.

• The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.

Since 2006, some manufacturers have voluntarily revised their product labeling to identify these potential safety concerns. However, the voluntary changes to labeling do not address all of the labeling requirements in the new rule.

For example, the new rule includes a warning on products containing acetaminophen that instructs consumers to ask a doctor before they are taking the blood thinning drug warfarin. The new rule requires all manufacturers to re-label their products within one year of today’s date.

Safety data reported in medical literature indicate that:

• People sometimes take more acetaminophen than the labeling recommends.

• Others unknowingly take multiple products containing acetaminophen at the same time.

Exceeding the recommended dosage of acetaminophen may increase the risks for severe liver damage. Alcohol use can also increase the risk of liver damage with acetaminophen.

The risk for stomach bleeding may increase:

• In people who use NSAIDs and who are taking blood-thinning drugs (anticoagulants) or steroids.

• For people who take multiple NSAIDs at the same time,

• Or in people who take them longer than directed.

• Alcohol use can increase the risk for stomach bleeding with NSAIDs use.

An FDA Advisory Committee meeting will be convened on June 29 & 30, 2009, to discuss further steps the FDA could take to reduce the risk of liver damage associated with acetaminophen overdoses.

To read the final rule on the relabeling of OTC pain relievers and fever reducers, go to http://edocket.access.gpo.gov/2009/pdf/E9-9684.pdf

To read the FR Notice announcing the FDA Advisory Committee meeting, see link below:http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-9380.pdf




Post a Comment

Featured Products From the ProHealth Store
Ultra EPA  - Fish Oil Vitamin D3 Extreme™ Ultra ATP+, Double Strength

Looking for Vitamins, Herbs and Supplements?
Search the ProHealth Store for Hundreds of Natural Health Products


Article Comments



Be the first to comment on this article!

Post a Comment


 
NAD+ Ignite with Niagen

Featured Products

Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%

Natural Remedies

The Remarkable Benefits of Reishi Medicinal Mushrooms The Remarkable Benefits of Reishi Medicinal Mushrooms
Fatigue & Fibro Fog: Could You Have a B-12 Deficiency? Fatigue & Fibro Fog: Could You Have a B-12 Deficiency?
Mitochondria-Booster NIAGEN® Shows Promise in First Human Clinical Trial Mitochondria-Booster NIAGEN® Shows Promise in First Human Clinical Trial
Complete and Natural Menopause Relief Complete and Natural Menopause Relief
Natural Support for Mood, Sleep and Mental Focus? L-theanine Natural Support for Mood, Sleep and Mental Focus? L-theanine

CONTACT US
ProHealth, Inc.
555 Maple Ave
Carpinteria, CA 93013
(800) 366-6056  |  Email

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
SHOP WITH CONFIDENCE
Credit Card Processing
SUBSCRIBE TO OUR NEWSLETTERS
Get the latest news about Fibromyalgia, M.E/Chronic Fatigue Syndrome, Lyme Disease and Natural Wellness

CONNECT WITH US ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus

© 2017 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map