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Actifed, Pseudoephedrine/Triprolidine (generic): Frequently Asked Questions

What is the difference between ephedrine and pseudoephedrine?

Although they are cousin chemicals -- both have the same molecular formula and bonds -- they are structurally different. Both serve as decongestants by basically shrinking the blood vessels in the nose; there is less tissue swelling and people can breathe better. Pseudoephedrine is more widely used in sinus and allergy medications, and ephedrine is used in asthma medication. Ephedrine alkaloids also naturally come from ephedra, the herbal supplement banned by the FDA in 2004.
Source: www.pbs.org

What is Pseudoephedrine?

Pseudoephedrine is an active ingredient in many medicines regulated by the U.S. Food and Drug Administration to relieve nasal and sinus congestion caused by the common cold, hay fever and other upper respiratory allergies. Pseudoephedrine has also been used illegally to make methamphetamine, an illegal substance commonly known as "meth".

Is phenylephrine a restricted decongestant, like pseudoephedrine?

Phenylephrine is a non-restricted decongestant. The current regulations that apply to the sale of pseudoephedrine products do not apply to phenylephrine.

What is the difference between pseudoephedrine and phenylephrine?

Pseudoephedrine and phenylephrine are both nasal decongestants that the FDA has approved as being effective for the treatment of sinus and nasal congestion. Pseudoephedrine and phenylephrine have different dosage recommendations. Dosage (Maximum Daily Dosage) Drug Adult/Children 12 years or older Phenylephrine 10 mg every 4 hours (60 mg) Pseudoephedrine 60 mg every 4-6 hours (240 mg)

What is the difference in dosage of pseudoephedrine and phenylephrine?

Dosage (Maximum Daily Dosage) Drug Adult/Children 12 years or older Phenylephrine 10 mg every 4 hours (60 mg) Pseudoephedrine 60 mg every 4-6 hours (240 mg)

Does Alka-Seltzer Plus® contain Pseudoephedrine (PSE)?

At this time, all of our products contain the nasal decongestant Phenylephrine Hydrochloride. We are no longer manufacturing products with Pseudoephedrine. This ingredient was removed from formulations in 2006.

How does phenylephrine compare to pseudoephedrine as far as safety and efficacy?

Pseudoephedrine and phenylephrine are both nasal decongestants that the Food and Drug Administration (FDA) has approved as being safe and effective for the treatment of sinus and nasal congestion, when used as directed.

Where can I purchase TYLENOL® products containing pseudoephedrine?

TYLENOL® Cold Severe Congestion and Tylenol Sinus Severe Congestion may still be purchased from the pharmacy in many retail locations. You do not need a prescription to purchase these products. Ask your pharmacist about the availability of these products.

What statutes impact the sale of pseudoephedrine products?

A North Carolina state statute, the Methamphetamine Lab Prevention Act, and a federal statute, the Combat Methamphetamine Epidemic Act, regulate the sale of pseudoephedrine products. The federal statute does not preempt the state statute, so pharmacists must comply with the stricter of the federal and state standards. Click here to read more information on the Methamphetamine Lab Prevention Act of 2005.

What pseudoephedrine products are subject to the statute?

Under the North Carolina statute, “[a]ny pseudoephedrine product in the form of a tablet or caplet containing pseudoephedrine as the sole active ingredient or in combination with other active ingredients shall be stored and sold behind a pharmacy counter.” Pseudoephedrine products “in the form of a liquid, liquid capsule, gel capsule or pediatric product” are not subject to regulation under the North Carolina statute. ...

Where can I find information on the pseudoephedrine sales restrictions?

On March 6, 2006 the Federal USA Patriot Improvement and Reauthorization Act of 2005 (HR 3199) was signed into law. This Federal Act included Title VII, also known as the Combat Methamphetamine Epidemic Act (CMA) of 2005. Title VII places restrictions on the storage and sale of pseudoephedrine and ephedrine based products. You may visit www.fda.gov/cder/news/methamphetamine for general information and overview of the law. The actual law can be viewed at: http://thomas.loc.gov or http://www.govtrack.us enter bill “HR3199”. ...

Who is authorized to sell cough and cold medicine containing pseudoephedrine and ephedrine?

OTC cough and cold medicine containing pseudoephedrine and ephedrine may only be sold by a pharmacist or pharmacy technician from behind the pharmacy counter in a pharmacy.

What will happen if I take pseudoephedrine?

High doses of pseudoephedrine can cause irregular heartbeat, headaches, difficulty breathing, anxiety, and seizures. Though some people use pseudoephedrine recreationally, there is too much pseudoephedrine in these products to use them as a source for DXM.

Do any TYLENOL® products still contain pseudoephedrine?

TYLENOL® Cold Severe Congestion and TYLENOL® Sinus Severe Congestion still contain pseudoephedrine. They are available without a prescription, but only from behind the pharmacy or retail service counter. These products will also be sold through some online retailers who meet certain requirements. Ask your pharmacist about the availability of these products.

Are all pseudoephedrine-containing products only sold from behind the counter?

Both statutes require that all tablet or caplet pseudoephedrine products be sold from behind the counter. The federal statute also requires that gel capsule pseudoephedrine products be sold from behind the counter. Liquid pseudoephedrine products may be sold from the pharmacy’s shelves.

Why can’t my child purchase pseudoephedrine products?

The North Carolina statute provides that pseudoephedrine tablets and caplets may be sold at retail only to a person at least 18 years of age. Back to Consumer FAQs Index

How much pseudoephedrine can I sell a customer?

The North Carolina statute was amended in 2006, and limits a single over-the-counter transaction to no more than two packages containing a combined total of less than 3.6 grams of pseudoephedrine. No person may purchase more than three packages containing a total of more than 9 grams of pseudoephedrine within 30 days. ...

Does either the state or federal pseudoephedrine statute apply to hospital pharmacies?

The North Carolina statute imposes limitations on the “retail sale” of pseudoephedrine products and upon “retailers.” The Act defines a retailer as “an entity that is the general owner of an establishment where pseudoephedrine products are available for sale.”

How much pseudoephedrine can I purchase at one time?

A person can purchase up to nine grams or three boxes of pseudoephedrine at one time. You can determine the grams by multiplying the number of milligrams of pseudoephedrine in each tablet by the number of tablets in each box. Multiply this number by .001 for the total number of grams in each box. When determining the grams of pseudoephedrine it does not matter if it is in a combination product or a single active ingredient product.

What will be required of me when I purchase a product with ephedrine or pseudoephedrine?

To purchase products in non-convenience packaging you must be at 18 years of age or older; and You will be required to show the clerk a state or federal ID card with a photograph. You will be required to enter specific information and sign the Indiana State Police log. The clerk will certify the entry in the log.
Source: www.in.gov

Why can't convenience and grocery stores carry cough and cold tablets containing pseudoephedrine and multi-ingredient ephedrine?

Only businesses registered with the Missouri State Bureau of Narcotics and Dangerous Drugs and the U.S. Drug Enforcement Administration are permitted to stock controlled substances.

Why do I have to buy cough and cold tablets containing pseudoephedrine and multi-ingredient ephedrine in a pharmacy?

Effective July 15, 2005, solid tablet dosage forms of OTC pseudoephedrine and multi-ingredient ephedrine products are schedule V controlled substances and may only be sold from behind the pharmacy counter in a licensed pharmacy.

How many packages of pseudoephedrine may a pharmacist dispense without a prescription to an individual in a single day?

There is no limit to the number of packages. However, federal law limits the quantity of pseudoephedrine that may be dispensed by a pharmacist in a single transaction or a single day to 3600 mg. Iowa law limits the quantity of pseudoephedrine that may be dispensed within a 30-day period to 7500 mg. Refer to Board Rules in Chapter 10 ( 10.32 ) for more information regarding dispensing Schedule V substances without a prescription.

Has Oregon’s pseudoephedrine law reduced meth use?

The number of local methamphetamine “labs” discovered by law-enforcement officials has dropped dramatically since Oregon started requiring a doctor’s prescription to obtain pseudoephedrine (one of the precursors in methamphetamine production). In 2001, state law enforcement agencies found 587 labs; as of November, they’d found 21 in 2007 (source: Register-Guard, 11/24/07). The law went into effect in July 2006. However, so far, meth arrests are holding steady in Oregon. ...
Source: www.ohsu.edu

Why can’t I find pseudoephedrine products on the shelf of my pharmacy?

In 2005, the North Carolina General Assembly passed the Methamphetamine Lab Prevention Act. In 2006 Congress passed the Combat Methamphetamine Epidemic Act. Both statutes require that many pseudoephedrine-containing products be stored and sold from behind the pharmacy counter. You may still purchase these products, but you are limited in the amount you can purchase, and you must sign a logbook with each purchase.

Why must I sign a logbook when I purchase pseudoephedrine products, and what happens to my information in the logbook?

Both statutes require a purchaser of pseudoephedrine tablets or caplets to sign a logbook and provide a name and address. These logbooks must be kept by the pharmacy for two years. The logbooks are not public records and information in them may only be disclosed to law enforcement personnel.

What are the new training and training log requirements for the sale of pseudoephedrine products in NC?

Please click here to read a memo from the NC DHHS Commission for Mental Health, Developmental Disabilities and Substance Abuse Services .

Do all products that contain pseudoephedrine need to be behind a counter or locked up?

Only products where pseudoephedrine is the single active ingredient need to be behind a counter or locked up. Single active ingredient pseudoephedrine is products where pseudoephedrine is the only medicine provided in the product. There may be other inert ingredients in the product that provide no medicinal benefit. Gel caps and liquid preparations where pseudoephedrine is the single active ingredient are exempt from this requirement. Combination pseudoephedrine products are exempt from this requirement.

product with pseudoephedrine?

The reformulated product is a replacement for ACTIFED® with pseudoephedrine. Back to Top Can I take an

What does it mean that cough and cold tablets containing pseudoephedrine and tablets containing ephedrine with other ingredients are schedule V controlled substances?

It has been found that solid dosage forms of over the counter (OTC) pseudoephedrine and multi-ingredient ephedrine products are used to illegally manufacture methamphetamine. A law was passed that added these products to the list of Schedule V controlled substances and requires that they may only be sold in pharmacies. Only a pharmacist or a registered pharmacy technician may sell the products. OTC cough and cold medicine in liquid and liquid-filled gel capsule forms are exempt from this scheduling action.
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