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FDA Advisory Committee meeting on acetaminophen

A very important discussion took place at the FDA Advisory Committee meeting held May 17-18, 2011 about an issue we take very seriously — updated dosing information for OTC single-ingredient acetaminophen pediatric products, and ways to minimize medication errors. Novartis Consumer Health, Inc., along with the Consumer Healthcare Products Association (CHPA) and other industry manufacturers, participated fully in this meeting and is committed to the review process.

Novartis Consumer Health is committed to the safety of children who use our products and to providing the highest quality over-the-counter (OTC) medicines. All Novartis OTC products are safe and effective when used as directed, and consumers can continue to use these products. Consumer safety is our number one priority, and consumers have taken acetaminophen safely when used as directed on the package label for more than 45 years.

Novartis Consumer Health will take appropriate actions based on FDA's recommendations to ensure continued safe use of our products.

Here are a few helpful reminders on how to use pediatric products containing acetaminophen safely:

• Read the information on the OTC "Drug Facts" label and follow directions.
• Be sure you understand the following:
• the dose, which is how much acetaminophen one can take at one time
• how many hours you must wait before taking or giving a child another dose of acetaminophen
• how many doses of acetaminophen one can take safely each day
• when to stop taking acetaminophen and ask a doctor for help
• Do not take more than directed, even if your pain or fever isn’t any better. Taking more acetaminophen than directed can put you at risk for liver damage.
• Do not take more than one medicine that contains acetaminophen. Check the active ingredients of all your medicines to make sure you are taking no more than one medicine containing acetaminophen at a time.