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Notified FDA in writing that Sudafed 12Hour Capsules (pseudoephedrine - gpo

Notified FDA in writing that Sudafed 12Hour Capsules (pseudoephedrine - gpo 2025

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The document outlines the withdrawal of marketing approval for Sudafed 12-Hour Capsules by the FDA, clarifying that it was not due to safety or effectiveness concerns. It also announces an upcoming meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to discuss new drug applications for diabetes and osteoporosis treatments, with a portion of the meeting closed to the public. Additionally, it mentions government-owned inventions available for licensing related to a viral etiology for childhood leukemia.

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Why is pseudoephedrine restricted?

Pseudoephedrine (PSE) is the main ingredient used to make methamphetamine (meth), a highly addictive stimulant drug. 1 PSE is a nasal decongestant typically found in nonprescription cold, allergy, and sinus medications, making it an easy source for people who operate illegal meth labs to obtain this precursor chemical.

Can you buy two boxes of pseudoephedrine?

A person shall not purchase more than three thousand six hundred milligrams of pseudoephedrine, either separately or collectively, within a twenty-four-hour period from a pharmacy, or more than one package of a product containing pseudoephedrine within a twenty-four-hour period from a retailer in violation of section

Can I still buy Sudafed with pseudoephedrine?

From the #1 pharmacist recommended brand among oral OTC decongestants, these decongestant tablets with pseudoephedrine HCl are suitable for adults and children ages 6+. SUDAFED Maximum Strength Sinus Congestion tablets are available for in-store purchase only, behind the pharmacy counter, without a prescription.

How many boxes of Sudafed can you buy in a month?

Currently, the Code prohibits a person from, among other things, purchasing more than nine grams of ephedrine or pseudoephedrine alone or in a mixture within a 30-day period.

What is the maximum amount of pseudoephedrine per month through mail?

Individuals can purchase no more than 3.6 grams of pseudoephedrine in a single day from retail stores. Over a 30-day period, an individual can receive a limit of 9 grams from retail sources. For mail orders, the limit is specifically set at 7.5 grams to further restrict bulk purchases and potential abuse.

How many boxes of pseudoephedrine can I buy a month?

No person may purchase products containing more than 3.6 grams of EPH, PSE or both in one day, or more than 7.2 grams of EPH or PSE or both in a 30 day period unless dispensed upon prescription, sold to a licensed health care provider, pharmacist, retail distributor, wholesaler, manufacturer, or an agent of any of

Why is Sudafed a banned substance?

Pseudoephedrine can be misused as an ingredient for the illicit manufacture of methamphetamines. In 2005, the FDA created the Combat Methamphetamine Epidemic Act, which banned over-the-counter sales of cold medicines that included the ingredient pseudoephedrine, requiring them to be sold behind the counter.

Why can you only buy one box of Sudafed?

The law limits the amount an individual can purchase in a 30-day period. These changes were made after a surge of reported methamphetamine use revealed that people were using easily accessible over-the-counter medications that contained pseudoephedrine in order to manufacture methamphetamines in labs at home.

Notified FDA in writing that Sudafed 12Hour Capsules (pseudoephedrine - gpo 2025

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