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Pseudoephedrine

What is pseudoephedrine?
Pseudoephedrine (PSE) is an FDA-recognized safe and effective decongestant ingredient that was commonly used in many cough, cold, and flu products until regulations prohibited its use in direct-access over-the-counter (OTC) products in 2006. Current regulations limiting OTC access to PSE products were enacted to restrict availability to persons who would use them to manufacture the illegal drug methamphetamine. PSE products are now sold behind the pharmacy counter and are safe and effective when used as directed.

Is PSE safe?
PSE is safe when used as directed. It is important to note that the safety of PSE has been well established. The controversy surrounding PSE is limited to a product misuse/abuse issue.

How does PSE work?
PSE works by constricting blood vessels in the nose in order to decrease blood flow to the area and open air passageways.

What is the dose of PSE in NyQuil® D?
There are 30 mg of PSE per tablespoon of NyQuil D. The dose for adults and children 12 years and older is 2 tablespoons every six hours. PSE has been proven to be safe when used as directed. The controversy surrounding PSE is limited to a product misuse/abuse issue.

Are you introducing NyQuil D with PSE because phenylephrine doesn't work?
No. P&G is launching NyQuil D because we are a leading provider of cough, cold, and flu products worldwide with an extensive line of products to suit the needs of a range of consumers.

Is there a limit on how much I can buy?
Yes. The Combat Methamphetamine Epidemic Act of 2005 that became law in 2006 limits the monthly amount of PSE that any individual can purchase.

What is in NyQuil D?
NyQuil D has the same active ingredients as NyQuil (acetaminophen for pain reliever/fever reducer, dextromethorphan for cough suppressant, doxylamine succinate as an antihistamine), plus PSE for up to six hours of nasal congestion relief. PSE is the decongestant that was used in NyQuil products for nearly 40 years before it was voluntarily removed due to new regulations governing access to all PSE products.

Do I need a prescription now to buy NyQuil D?
No. NyQuil D is available without a prescription through retailers nationwide and is sold behind the counter.

For more information, check out this information about safety of over-the-counter medications.