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phenylephrine (ADVIL CONGESTION RELIEF, NALDECON, NEO-SYNEPHRINE, SUDAFED PE)


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Children 12 and under should not be given cough and cold meds (October 22, 2007)

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FDA Advisory Committee: Over-the-Counter Oral Phenylephrine Is Not Effective for Relief of Nasal Congestion
December 2023
In 2022, people in the U.S. purchased as least 242 million over-the-counter products that contain oral phenylephrine at a cost of at least $1.8 billion. Learn why oral phenylephrine is not effective for the relief of nasal congestion and why the FDA should prioritize removal of over-the-counter oral phenylephrine products from the U.S. market.
Drug-Induced Insomnia
March 2023
Learn about the numerous prescription and over-the-counter medications that can cause or exacerbate insomnia.
Drug-Induced Urinary Incontinence
September 2022
Numerous prescription and over-the-counter drugs can cause or exacerbate urinary incontinence. Knowing which medications prescribed or recommended by your doctor cause urinary incontinence will allow you to take steps to prevent or minimize this common, troubling adverse drug effect.
Treatment for Nasal Allergies: An Updated Review
April 2016
With spring time pollen counts soaring, many patients with seasonal nasal allergies will be looking for relief from allergy medications. Learn the best available treatments to stay safe and relatively symptom-free during allergy season and throughout the year.

ADDITIONAL INFORMATION FROM PUBLIC CITIZEN

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Press Statement: FDA Must Prioritize Removal of Oral Phenylephrine From Shelves (HRG Publication #2665)
As a follow-up on Public Citizen’s testimony urging the Food and Drug Administration’s (FDA) Nonprescription Drugs Advisory Committee to vote against the efficacy of oral phenylephrine for nasal congestion, we are asking the agency to prioritize prompt removal of this drug from the U.S. market.
Testimony Before the FDA’s Nonprescription Drugs Advisory Committee Regarding the Efficacy of Oral Phenylephrine as a Nasal Congestion (HRG Publication #2664)
In a PC testimony before the Food and Drug Administration’s (FDA’s) Nonprescription Drugs Advisory Committee (NDAC), Public Citizen urged the committee to vote “No” on the questions regarding whether the current evidence supports the effectiveness of orally administered oral phenylephrine for nasal congestion and whether a higher oral dosage of the drug would be safe and effective. This is because the current evidence — from updated FDA analysis of original prior studies that had used outdated technology/research design as well as evidence from three new well-designed clinical trials — clearly shows that orally administered phenylephrine is not effective at any dose that can be administered with a reasonable margin of safety.
FDA Neglecting Its Responsibility to Protect Children From Risky, Ineffective Cough and Cold Medicines
By simply warning parents not to administer over-the-counter cough and cold remedies to children under the age of 2, the U.S. Food and Drug Administration (FDA) has failed to properly address the glaring risks presented by this category of drugs, Public Citizen said today.
Children Under 12 Should Not Be Given Cough, Cold Medications, Public Citizen Tells FDA
Children under the age of 12 should not be given over-the-counter (OTC) cough and cold medicines, and remedies aimed specifically at children should be removed from the U.S. market, Public Citizen said today in testimony before the Food and Drug Administration (FDA).

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