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{{Short description|Brand of nasal decongestants}}
{{update |date=November 2025 |reason=Some of the regulation-related and country-specific market information is out of date, and the cited studies about phenylephrine are more than 15 years old. More recent studies have concluded that orally administered phenylephrine is not effective as a nasal decongestant despite continuing to be sold for that purpose.}}
'''Sudafed''' is a [[brand]] name and registered [[trademark]] for over the counter (OTC) [[decongestant]]s manufactured by [[McNeil Laboratories]] (a division of [[Johnson & Johnson]]) for sale in [[Australia]], [[New Zealand]], [[Canada]], [[Republic of Ireland|Ireland]], [[South Africa]], the [[United Kingdom]], and the [[United States]].  Before being acquired by Johnson & Johnson in 2006, Sudafed was owned by [[Pfizer]].

Sudafed is used to treat symptoms of the [[common cold]], [[sinusitis]] and [[nasal congestion]].

The original [[formulation]] of Sudafed contains the active ingredient [[pseudoephedrine]], but formulations without pseudoephedrine are also being sold under the Sudafed brand.

In 2016 it was one of the biggest selling branded over-the-counter medications sold in Great Britain, with sales of £34.4 million.<ref>{{cite news|title=A breakdown of the over-the-counter medicines market in Britain in 2016|url=http://www.pharmaceutical-journal.com/20202662.article?amp;utm_medium=email&amp;|access-date=29 May 2017|publisher=Pharmaceutical Journal|date=28 April 2017}}</ref>

==Active ingredients==

The brand name Sudafed is used for several [[formulations]] that contain different active ingredients:

; [[Pseudoephedrine]]
: The active ingredient (as the [[hydrochloride]] salt) of the original Sudafed. In the UK, this is now sold under the name "Sudafed Decongestant". As of 2015 "Sudafed Sinus - Pressure & Pain" tablets contain Pseudoephedrine Hydrochloride.
; [[Phenylephrine]] (hydrochloride)
: These products are sold as alternatives to [[pseudoephedrine]] formulations. In the United Kingdom, formulations containing phenylephrine are sold under various names (Sudafed Blocked Nose capsules, Sudafed Blocked Nose & Sinus capsules, Sudafed Mucus Relief Triple Action Cold & Flu tablets, Sudafed Sinus Pressure & Pain tablets, and Sudafed Day & Night capsules). In other countries the name "Sudafed PE" is used.
; [[Oxymetazoline]] (hydrochloride)
: The active ingredient in products using the name Sudafed OM in the United States; these are formulated as topical [[nasal spray]]s.
; [[Xylometazoline]] (hydrochloride)
: The active ingredient in a product formulated as topical [[nasal spray]] and sold in the United Kingdom under the name Sudafed Blocked Nose Spray.

In the UK, some Sudafed-branded products containing phenylephrine also contain other active ingredients:

; [[Paracetamol]] ({{aka}} acetaminophen)
: Sudafed Blocked Nose capsules, Sudafed Blocked Nose & Sinus capsules, Sudafed Day & Night capsules, and Sudafed Mucus Relief Triple Action Cold & Flu tablets
; [[Ibuprofen]]
: Sudafed Sinus Pressure & Pain tablets
; [[Caffeine]]
: Sudafed Day & Night capsules (day capsules only) and Sudafed Blocked Nose & Sinus capsules
; [[Guaifenesin]]
: Sudafed Mucus Relief Triple Action Cold & Flu tablets

==Switch to phenylephrine==
{{globalize|date=October 2012}}
In late 2004, Pfizer publicly disclosed its plans to make available a new over-the-counter product, Sudafed PE, which does not include pseudoephedrine. Decongestants with other ingredients were completely converted to phenylephrine later in 2005. Original Sudafed is still offered behind the counter to customers 18 years of age or older upon request, requiring the customer to show ID and sign a sales log next to a record of their name and address.

The new product was prompted by existing and proposed restrictions on the availability of pseudoephedrine-based products.  U.S. state laws imposing such restrictions were in response to pseudoephedrine's role as an ingredient used to synthesize the [[stimulant]] [[methamphetamine]].

Several pharmacists have questioned the effectiveness of orally-administered phenylephrine as a nasal decongestant.<ref name="Hendeles2006">{{cite journal| author=Heldeles, L. and Hatton, R.|title= Oral phenylephrine: An ineffective replacement for pseudoephedrine? | journal=Journal of Allergy and Clinical Immunology| volume=118| issue= 1|pages=279–280 |pmid=16815167| date=2006 | doi=10.1016/j.jaci.2006.03.002}}</ref><ref name="UFL">{{cite web | url=http://news.ufl.edu/2006/07/19/decongensant/ | author=University of Florida (press release) | title=UF researchers question effectiveness of decongestant | date=2006-07-19 | access-date=2008-03-15 | url-status=dead | archiveurl=https://web.archive.org/web/20131003021027/http://news.ufl.edu/2006/07/19/decongensant/ | archivedate=2013-10-03 | df= }}</ref> At least one meta-analysis has concluded that it is more effective than placebos,<ref name="GSK">{{cite journal | author=Kollar C, Schneider H, Waksman J, Krusinska E.| date= 2007 |doi=10.1016/j.clinthera.2007.05.021 |title=Meta-analysis of the efficacy of a single dose of phenylephrine 10 mg compared with placebo in adults with acute nasal congestion due to the common cold | journal=Clinical Therapeutics | volume=29| pages=1057–1070 | pmid=17692721 | issue=6 }}</ref> while other research has not found sufficient evidence to support this claim.<ref name="Annals">{{cite journal|author=Hatton, R.C.|url=http://www.theannals.com/cgi/content/abstract/aph.1H679v1|title=Efficacy and Safety of Oral Phenylephrine: A Systematic Review and Meta-Analysis|journal=Annals of Pharmacotherapy|volume=41|pages=381–390|doi=10.1345/aph.1H679|pmid=17264159|date=2007|format=abstract|issue=3|display-authors=etal|url-status=dead|archiveurl=https://web.archive.org/web/20070227143703/http://www.theannals.com/cgi/content/abstract/aph.1H679v1|archivedate=2007-02-27|df=}}(published online Jan 2007)</ref><ref name="danzig09">{{Cite journal 
| last1 = Horak | first1 = F.
| last2 = Zieglmayer | first2 = P.
| last3 = Zieglmayer | first3 = R.
| last4 = Lemell | first4 = P.
| last5 = Yao | first5 = R.
| last6 = Staudinger | first6 = H.
| last7 = Danzig | first7 = M.
| title = A placebo-controlled study of the nasal decongestant effect of phenylephrine and pseudoephedrine in the Vienna Challenge Chamber 
| journal = Annals of Allergy, Asthma & Immunology 
| volume = 102 
| issue = 2 
| pages = 116–20 
| date = 11 November 2008
| publication-date = February 2009
| doi = 10.1016/S1081-1206(10)60240-2 | pmid=19230461
}}</ref><ref name="yao09">{{Cite journal 
| last1 = Day | first1 = J. H. 
| last2 = Briscoe | first2 = M. P. 
| last3 = Ratz | first3 = J. D. 
| last4 = Danzig | first4 = M. 
| last5 = Yao | first5 = R. 
| title = Efficacy of loratadine-montelukast on nasal congestion in patients with seasonal allergic rhinitis in an environmental exposure unit 
| journal = Annals of Allergy, Asthma & Immunology 
| volume = 102 
| issue = 4 
| pages = 328–38 
| year = 2009 
| doi = 10.1016/S1081-1206(10)60339-0 | pmid=19441605
}}</ref>{{update-inline |date=November 2025 |reason=This information is more than 15 years old. It has since been confirmed ineffective.}}

== Regulation on sale ==

In the [[United Kingdom]], "Sudafed Decongestant" containing 60&nbsp;mg of pseudoephedrine hydrochloride per tablet is available in packs of 12 tablets from pharmacies and is classified as a [[Over-the-counter drug#United Kingdom|Pharmacy Only Medication]] ("[P]"), so any sale follows a series of questions from the pharmacist to determine if it is safe. Historically, packs of 24 tablets were also available, but the maximum pack size for OTC sales was reduced to 12 tablets as a measure to counteract misuse. The version that contains phenylephrine is not restricted and may be purchased off the shelf from supermarkets and other stores. As of 2015, "Sudafed Sinus - Pressure & Pain tablets" only contain 30 mg.

In Australia, Sudafed with up to 60&nbsp;mg of pseudoephedrine is available subject to a pharmacist matching the purchaser's identity to the Project STOP database to determine if the purchase history is consistent with personal use. Under Project STOP, a maximum of one pseudoephedrine containing drugs can be sold over the counter per day. However, doctors still retain the ability to prescribe the drugs. In Queensland, all pharmacists dispensing pseudoephedrine-based substances must use the Project STOP database. 2015 Prescription now required.<ref>[http://projectstop.com.au/faq.html ] {{webarchive |url=https://web.archive.org/web/20110329010940/http://projectstop.com.au/faq.html |date=March 29, 2011 }}</ref> If identification is not provided, the pharmacist may, at his or her discretion, still provide the medication.

In Canada,<ref name="sudafedca">[http://www.sudafed.ca sudafed.ca], ''[[Johnson & Johnson]]'', Retrieved 23 April 2010</ref> Sudafed contains phenylephrine hydrochloride, pseudoephedrine hydrochloride in a 120&nbsp;mg "12 hour time release" capsule, or pseudoephedrine hydrochloride combined with other ingredients (e.g. Ibuprofen).{{update-inline |date=November 2025}}

In the United States, section 711 of the Combat Methamphetamine Epidemic Act of 2005 reclassifies phenylpropanolamine, pseudoephedrine and ephedrine as Schedule Listed Chemicals (SLC).<ref name="fda">{{cite web|author=Human Drug Information |url=http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm072423.htm |title=Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine |website=[[U.S. Food & Drug Administration]] |date= |access-date=2012-02-13}}</ref> SLCs were reduced by the Federal per-transaction sales limit from 9 grams to 3.6 grams. The amount recently{{timeframe |date=November 2025}} proposed by the Administration requires behind-the-counter storage or locked cabinet storage.

==References== 
{{reflist|30em}}

==External links==
*{{Official website|http://www.sudafed.com/ }}
*[http://www.sudafed.ca/ Official Canadian Website]
*[http://www.sudafed.co.uk/ Official UK Website]

{{Johnson & Johnson}}

[[Category:Decongestants]]