What does the research show about oral decongestants?

Oral decongestants

Trials found pseudoephedrine eased cold and allergy congestion slightly more than placebo and cut ear barotrauma in adults when flying or diving. Oral phenylephrine at the 10 mg label dose did not differ from placebo in newer trials, and FDA advisers voted 16 to 0 that data do not support it. Pseudoephedrine raised blood pressure slightly.

Add to Bio HackChecked 2026-11-14

Status: Both are sold without a prescription in the US as nasal decongestants. Pseudoephedrine may be sold only from behind the counter or a locked cabinet, with monthly purchase limits, photo identification and a purchase record, under the Combat Methamphetamine Epidemic Act of 2005, and some states require a prescription. Oral phenylephrine is sold on open shelves under FDA's OTC monograph. In November 2024 FDA proposed removing oral phenylephrine as a nasal decongestant ingredient, and states products may be marketed until a final order.
Also called: pseudoephedrine, pseudoephedrine hydrochloride, Sudafed, Sudafed 12 Hour, Sudafed Sinus Congestion, Children's Sudafed, phenylephrine, oral phenylephrine, phenylephrine hydrochloride, Sudafed PE, PE products, nasal decongestant pills, behind-the-counter Sudafed
Taken for: stuffy nose, nasal congestion, sinus congestion and pressure, colds, hay fever, allergies, ear pain when flying, ear barotrauma when diving, exercise performance

Strong several reviews agree · Moderate one review or consistent trials · Limited one or a few small studies · Untested no study in people, listed with what it rests on

Shown to help4

ModerateShown to ease nasal congestion from colds slightly more than placebo in adults, a small pooled effect on low-quality evidence. One trial missed its main endpoint.
ModerateShown to cut ear barotrauma about 45% against placebo in adults who were flying or diving, in a meta-analysis of three older trials. A hyperbaric oxygen trial found no effect.
LimitedOne industry-funded trial in children aged 6 to 11 found pseudoephedrine 30 mg eased congestion more than placebo over the first 8 hours, with weaker results on day 2.
LimitedOne crossover trial in an allergen chamber found pseudoephedrine 60 mg eased congestion more than both placebo and phenylephrine 12 mg, which did not differ from placebo.

Reported risks7

LimitedTwo trials in children found more drowsiness on pseudoephedrine than placebo, 60% against 27% at takeoff in young children on flights.Very common
ModerateShown to raise systolic blood pressure about 1 mm Hg and heart rate about 3 beats a minute, with larger rises at higher doses and with immediate-release forms.How often is not known
ModerateMixed results: a meta-analysis linked first-trimester pseudoephedrine to 1.51 times the risk of gastroschisis, while a large cohort found no rise in major malformations.How often is not known
LimitedEMA concluded pseudoephedrine is associated with PRES and RCVS, rare conditions that reduce blood supply to the brain, from a few reported cases. None were fatal.How often is not known
LimitedThe labels say not to use either decongestant with a prescription MAOI, or for 2 weeks after stopping one.How often is not known
LimitedThe labels ask people with heart disease, high blood pressure, thyroid disease, diabetes or trouble urinating from an enlarged prostate to consult a doctor before use.How often is not known
LimitedFDA states pseudoephedrine can be used illegally to make methamphetamine, which is why US law keeps it behind the counter with purchase limits and records.How often is not known

What people take it for, and what was found

Shown to help4

Moderate

Nasal congestion from colds, pseudoephedrine

Shown to ease nasal congestion from colds slightly more than placebo in adults, a small pooled effect on low-quality evidence. One trial missed its main endpoint.

Compared with placebo [1][2][3]

The numbers and sources

Effect: After a single 60 mg dose, nasal airway resistance over 0 to 3 hours was lower than on placebo, and objective measures on day 3 also favored pseudoephedrine [1]. In a 3-day trial of 60 mg four times daily, objective measures showed small improvements, total nasal volume rose 5.5% against placebo, and the primary endpoint, day 1 nasal airway resistance, did not differ [2]. A Cochrane review of 15 trials found multiple doses of decongestants improved subjective congestion about 3 hours after the last dose (SMD 0.49, 95% CI 0.07 to 0.92), a small effect, and could not pool single-dose studies [3].
Population: 238 people with colds, mean age 20 [1]; 216 adults with colds [2]; 15 trials with 1,838 participants, 14 of them adult only, 9 using pseudoephedrine [3].
Sources: [1], [2], [3]
Caveats: The pooled multi-dose estimate came from two studies, one oral and one nasal spray, and was rated low quality [3]. No trial reported overall well-being [3].

LimitedStudied in children

Nasal congestion in children with colds, pseudoephedrine

One industry-funded trial in children aged 6 to 11 found pseudoephedrine 30 mg eased congestion more than placebo over the first 8 hours, with weaker results on day 2.

Compared with placebo [4]

The numbers and sources

Effect: The weighted change in nasal congestion severity over 1 to 8 hours after the first dose favored pseudoephedrine (least squares mean difference 1.2). Secondary congestion endpoints supported this on day 1 and were only numerically favorable on day 2 [4].
Population: 568 children aged 6 to 11 with colds, 286 on pseudoephedrine and 282 on placebo, dosed as needed for up to 7 days [4].
Sources: [4]
Caveats: One trial, sponsored by a manufacturer with an industry trade group [4]. The pseudoephedrine label says not to use it under age 6 [5].

Limited

Allergic nasal congestion, pseudoephedrine against phenylephrine

One crossover trial in an allergen chamber found pseudoephedrine 60 mg eased congestion more than both placebo and phenylephrine 12 mg, which did not differ from placebo.

Compared with placebo and phenylephrine 12 mg [6]

The numbers and sources

Effect: Over 6 hours of grass pollen exposure, the change in nasal congestion score on phenylephrine did not differ from placebo, while pseudoephedrine improved it against placebo and against phenylephrine. Rhinomanometry and peak nasal inspiratory flow agreed. Neither drug changed symptoms outside the nose [6].
Population: 39 adults with grass pollen allergy in a 3-way crossover trial in the Vienna Challenge Chamber [6].
Sources: [6]
Caveats: One small trial of single doses. The authors note carryover bias in the crossover may have affected results [6].

Moderate

Ear barotrauma when flying or diving, adults

Shown to cut ear barotrauma about 45% against placebo in adults who were flying or diving, in a meta-analysis of three older trials. A hyperbaric oxygen trial found no effect.

Compared with placebo [14][15]

The numbers and sources

Effect: Across 3 double-blind trials, pseudoephedrine lowered the risk of otic barotrauma against placebo (RR 0.55, 95% CI 0.48 to 0.66, I² 1%), with lower risks of ear pain (RR 0.51), blockage (RR 0.50) and hearing loss (RR 0.49) [14]. In patients starting hyperbaric oxygen treatment, ear pain, eardrum injury and rescue medication use did not differ between pseudoephedrine and placebo [15].
Population: 4 double-blind randomized trials with 490 adults, 1992 to 1998, 3 of them on pseudoephedrine [14]; adults at their first hyperbaric oxygen treatment [15].
Sources: [14], [15]
Caveats: The trials are small and date from the 1990s [14]. The hyperbaric trial abstract gives no numbers [15].

Not shown to help3

Moderate

Nasal congestion, oral phenylephrine

Not shown to ease congestion at the 10 mg label dose in adults in newer trials. FDA's advisers voted 16 to 0 that the data do not support it.

Compared with placebo [7][8][9][10]; pseudoephedrine 60 mg [6]

The numbers and sources

Effect: Pooling 8 unpublished studies, phenylephrine 10 mg did not lower nasal airway resistance more than placebo (difference 10.1%, 95% CI -3.8 to 23.9), while 25 mg lowered it 27.6%. Patient-reported decongestion was not consistently better at any dose [7]. A second meta-analysis of 7 older crossover studies found phenylephrine 10 mg lowered nasal airway resistance more than placebo at 30 to 90 minutes [8]. In allergic rhinitis, doses of 10, 20, 30 and 40 mg every 4 hours for 7 days did not differ from placebo [9], nor did a 30 mg modified-release tablet every 12 hours (mean change -0.394 against -0.412 on placebo) [10]. In September 2023, FDA's Nonprescription Drugs Advisory Committee voted 16 to 0 that current data do not support the monograph dose as a nasal decongestant, and cited its low oral bioavailability [11]. In November 2024 FDA proposed removing oral phenylephrine from the monograph, stating the proposal rests on efficacy concerns, not safety concerns [12]. FDA states products can be marketed until a final order [13].
Population: 8 unpublished trials with 138 people with congestion [7]; 113 adults with colds in 7 crossover studies [8]; 539 adults with seasonal allergic rhinitis [9]; 575 adults with fall pollen allergy [10]; FDA review of historical and newer data [11][12].
Sources: [7], [8], [9], [10], [11], [12], [13]
Caveats: The two meta-analyses disagree, and both rest on small older studies that were not published [7][8]. The 2015 trial was open-label [9]. The FDA action applies to oral phenylephrine only, not to phenylephrine nasal sprays [12].

LimitedStudied in children

Ear pain on flights, young children

One small trial in children aged 6 months to 6 years found pseudoephedrine before a flight did not lower ear pain, 12% against 13% on descent.

Compared with placebo [16]

The numbers and sources

Effect: Ear pain was reported on 14% of flights. It did not differ between pseudoephedrine and placebo on ascent (4% against 5%) or descent (12% against 13%) [16].
Population: 50 children aged 6 months to 6 years on 91 commercial flights, given pseudoephedrine 1 mg/kg or placebo 30 to 60 minutes before departure [16].
Sources: [16]
Caveats: One small trial [16].

Moderate

Exercise performance

Not shown to change exercise performance meaningfully in healthy adults. Effects were trivial apart from a small heart rate rise and a small gain at doses above 170 mg.

Compared with placebo [17]

The numbers and sources

Effect: Across randomized placebo-controlled crossover trials, effects on time trial performance, perceived exertion, blood glucose and blood lactate were trivial. Heart rate rose slightly (effect size 0.43, 95% CI -0.01 to 0.88). Effects were larger in well-trained and younger people, in bouts under 25 minutes, and at doses above 170 mg (time trial effect size -0.24, heart rate 0.85) [17].
Population: Healthy men and women in double-blind crossover trials [17].
Sources: [17]
Caveats: The subgroup findings come from few trials. The authors judged the benefit marginal and likely smaller than caffeine's [17].

Doses studied

The adult cold trials used pseudoephedrine 60 mg as a single dose or four times a day for 3 days [1][2], and the children's trial used 30 mg tablets as needed for up to 7 days [4]. The allergen chamber trial used single doses of pseudoephedrine 60 mg and phenylephrine 12 mg [6], and the children's flight trial used pseudoephedrine 1 mg/kg [16]. The Sudafed label directs 2 tablets of 30 mg every 4 to 6 hours for ages 12 and over, no more than 8 tablets in 24 hours [5]. The phenylephrine meta-analyses tested single doses of 10 and 25 mg [7][8]. The allergic rhinitis trials used 10 to 40 mg every 4 hours for 7 days [9] and a 30 mg modified-release tablet every 12 hours [10]. The Sudafed PE label directs one 10 mg tablet every 4 hours, no more than 6 in 24 hours [18]. The exercise trials in the meta-analysis included doses above 170 mg [17].

Risks

Reported risks6

LimitedStudied in childrenVery common

Drowsiness in children

Two trials in children found more drowsiness on pseudoephedrine than placebo, 60% against 27% at takeoff in young children on flights.

The numbers and sources

How common: Very common: more than 1 in 10 people.
Effect: In young children given pseudoephedrine before flights, drowsiness at takeoff was 60% against 27% on placebo, with no difference at landing or in excitability [16]. In children aged 6 to 11 with colds, somnolence was reported in 71.9% on pseudoephedrine and 63.9% on placebo, insomnia in 34.4% and 38.9%, and nervousness in 20.0% and 23.6% [4].
Population: 50 children aged 6 months to 6 years on 91 flights [16]; 568 children aged 6 to 11 [4].
Sources: [16], [4]
Caveats: The children's cold trial counted sleepiness ratings, so rates were high in both groups [4].

ModerateHow often is not known

Blood pressure and heart rate, pseudoephedrine

Shown to raise systolic blood pressure about 1 mm Hg and heart rate about 3 beats a minute, with larger rises at higher doses and with immediate-release forms.

The numbers and sources

How common: How often is not known: the sources give no rate.
Effect: Pseudoephedrine raised systolic blood pressure by 0.99 mm Hg (95% CI 0.08 to 1.90) and heart rate by 2.83 beats a minute (95% CI 2.0 to 3.6), with no effect on diastolic pressure. In people with controlled hypertension, systolic pressure rose 1.20 mm Hg. Higher doses, immediate-release forms and shorter use gave larger rises [19].
Population: 24 randomized placebo-controlled trials with 1,285 adults [19].
Sources: [19]
Caveats: Averages across trials. The label asks people with high blood pressure or heart disease to ask a doctor first [5].

LimitedHow often is not known

Brain blood vessel syndromes, pseudoephedrine

EMA concluded pseudoephedrine is associated with PRES and RCVS, rare conditions that reduce blood supply to the brain, from a few reported cases. None were fatal.

The numbers and sources

How common: How often is not known: the sources give no rate.
Effect: After a review of all available data including post-marketing reports, EMA concluded pseudoephedrine is associated with posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). There were no fatal cases and most resolved after stopping the medicine. EMA restricted use in people with severe or uncontrolled high blood pressure or severe kidney disease or failure. It listed sudden severe headache, nausea, vomiting, confusion, seizures and vision changes as symptoms [20].
Population: Reported cases reviewed by EMA [20].
Sources: [20]
Caveats: EMA gives no rate. EU product information already warned of cardiovascular and cerebrovascular ischemic risks [20].

LimitedHow often is not known

Interaction with MAOI antidepressants

The labels say not to use either decongestant with a prescription MAOI, or for 2 weeks after stopping one.

The numbers and sources

How common: How often is not known: the sources give no rate.
Effect: Both the pseudoephedrine and phenylephrine labels say not to use the product while taking a prescription monoamine oxidase inhibitor, used for depression, psychiatric or emotional conditions or Parkinson's disease, or for 2 weeks after stopping it [5][18].
Population: Labeling statements [5][18].
Sources: [5], [18]
Caveats: No rate of harm is given.

LimitedHow often is not known

Conditions the labels name

The labels ask people with heart disease, high blood pressure, thyroid disease, diabetes or trouble urinating from an enlarged prostate to consult a doctor before use.

The numbers and sources

How common: How often is not known: the sources give no rate.
Effect: The Sudafed and Sudafed PE labels list heart disease, high blood pressure, thyroid disease, diabetes and trouble urinating due to an enlarged prostate as reasons to ask a doctor first, and say not to exceed the dose [5][18]. EMA restricted pseudoephedrine in severe or uncontrolled high blood pressure and severe kidney disease [20].
Population: Labeling and regulatory statements [5][18][20].
Sources: [5], [18], [20]
Caveats: No rate is given.

LimitedHow often is not known

Misuse to make methamphetamine

FDA states pseudoephedrine can be used illegally to make methamphetamine, which is why US law keeps it behind the counter with purchase limits and records.

The numbers and sources

How common: How often is not known: the sources give no rate.
Effect: FDA describes the Combat Methamphetamine Epidemic Act of 2005, which limits sales to behind the counter or locked cabinets, limits monthly purchases, requires photo identification, and requires stores to keep buyer records for at least two years. It applies to all products containing pseudoephedrine, ephedrine or phenylpropanolamine, and is enforced by the Drug Enforcement Administration [23].
Population: Regulatory statement [23].
Sources: [23]
Caveats: A regulatory measure, not a harm to the person taking it.

Mixed results1

ModerateStudied in pregnancyHow often is not known

Pregnancy

Mixed results: a meta-analysis linked first-trimester pseudoephedrine to 1.51 times the risk of gastroschisis, while a large cohort found no rise in major malformations.

The numbers and sources

How common: How often is not known: the sources give no rate.
Effect: Pooling observational studies, first-trimester pseudoephedrine and phenylpropanolamine were associated with gastroschisis, a defect of the abdominal wall (RR 1.51, 95% CI 1.16 to 1.97, I² 33%), with associations significant only in some subgroups [21]. In a cohort of 251,543 pregnancies, 313 exposed in the first trimester to a 120 mg pseudoephedrine tablet had no rise in major malformations overall (aRR 0.90, 95% CI 0.56 to 1.45) or by organ system [22].
Population: 18 observational studies covering 751,954 pregnancies [21]; 251,543 pregnancies in southern Israel, 1999 to 2017 [22].
Sources: [21], [22]
Caveats: Observational. The cohort had few exposed pregnancies, so it could not test a rare defect such as gastroschisis on its own [22]. The labels ask pregnant or breast-feeding women to consult a health professional first [5][18].

Checked, no increase found2

Moderate

Blood pressure, oral phenylephrine

Not linked to a consistent change in heart rate or blood pressure at doses of 25 mg or less, in a meta-analysis of placebo-controlled trials.

The numbers and sources

How common: How often is not known: the sources give no rate.
Effect: Phenylephrine showed no consistent effect on heart rate or blood pressure at doses of 25 mg or less [7]. FDA stated its proposal to remove oral phenylephrine is based on efficacy concerns, not safety concerns [12].
Population: Randomized placebo-controlled trials of single-ingredient oral phenylephrine [7].
Sources: [7], [12]
Caveats: Small trials. FDA's advisers cited cardiovascular safety concerns as one reason against testing higher doses for over-the-counter use [11].

Moderate

Side effects in short trials

Not linked to more adverse events than placebo in adults with colds over 1 to 10 days, 125 against 126 per 1,000 in a Cochrane review.

The numbers and sources

How common: How often is not known: the sources give no rate.
Effect: Across 7 multi-dose trials, adverse events occurred in 125 per 1,000 on decongestants and 126 per 1,000 on placebo (OR 0.98, 95% CI 0.68 to 1.40). Oral decongestants alone gave an OR of 0.95 (95% CI 0.65 to 1.39) [3]. The labels say to stop and ask a doctor if nervousness, dizziness or sleeplessness occur [5][18].
Population: Adults with colds in 7 trials, 6 of them oral [3].
Sources: [3], [5], [18]
Caveats: Low-quality evidence over short periods. Trials were too small for rare harms [3].

Claims tested and not found

That oral phenylephrine at the label dose relieves a stuffy nose. Newer trials of 10 to 40 mg every 4 hours and of a 30 mg modified-release tablet found no difference from placebo [9][10], and FDA's advisers voted 16 to 0 that the data do not support the monograph dose [11].
That pseudoephedrine prevents ear pain in young children who fly. In 91 flights, ear pain did not differ from placebo on ascent or descent [16].
That pseudoephedrine boosts exercise performance at usual doses. A meta-analysis of crossover trials found trivial effects on time trial performance [17].

Sources

Eccles R, Jawad MS, Jawad SS, Angello JT, Druce HM. Efficacy and safety of single and multiple doses of pseudoephedrine in the treatment of nasal congestion associated with common cold. American Journal of Rhinology. 2005. https://doi.org/10.1177/194589240501900105
Latte J, Taverner D. Clinical trial of 3 days of treatment with oral pseudoephedrine for the common cold in the southern hemisphere. American Journal of Rhinology. 2007. https://doi.org/10.2500/ajr.2007.21.3041
Deckx L, De Sutter AI, Guo L, Mir NA, van Driel ML. Nasal decongestants in monotherapy for the common cold. Cochrane Database of Systematic Reviews. 2016. https://doi.org/10.1002/14651858.cd009612.pub2
Gelotte CK, Albrecht HH, Hynson J, Gallagher V. A Multicenter, Randomized, Placebo-Controlled Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold. Journal of Clinical Pharmacology. 2019. https://doi.org/10.1002/jcph.1472
U.S. Food and Drug Administration. SUDAFED SINUS CONGESTION (pseudoephedrine hydrochloride) tablet, drug facts label. 2024. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c05d7e27-6821-468f-b27d-9c0b02a07b0f
Horak F, Zieglmayer P, Zieglmayer R, et al. A placebo-controlled study of the nasal decongestant effect of phenylephrine and pseudoephedrine in the Vienna Challenge Chamber. Annals of Allergy, Asthma & Immunology. 2009. https://doi.org/10.1016/s1081-1206(10)60240-2
Hatton RC, Winterstein AG, McKelvey RP, Shuster J, Hendeles L. Efficacy and safety of oral phenylephrine: systematic review and meta-analysis. Annals of Pharmacotherapy. 2007. https://doi.org/10.1345/aph.1h679
Kollar C, Schneider H, Waksman J, Krusinska E. 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. Clinical Therapeutics. 2007. https://doi.org/10.1016/j.clinthera.2007.05.021
Meltzer EO, Ratner PH, McGraw T. Oral Phenylephrine HCl for Nasal Congestion in Seasonal Allergic Rhinitis: A Randomized, Open-label, Placebo-controlled Study. Journal of Allergy and Clinical Immunology: In Practice. 2015. https://doi.org/10.1016/j.jaip.2015.05.007
Meltzer EO, Ratner PH, McGraw T. Phenylephrine hydrochloride modified-release tablets for nasal congestion: a randomized, placebo-controlled trial in allergic rhinitis patients. Annals of Allergy, Asthma & Immunology. 2016. https://doi.org/10.1016/j.anai.2015.10.022
U.S. Food and Drug Administration. September 11-12, 2023 Meeting of the Nonprescription Drugs Advisory Committee, minutes. 2023. https://www.fda.gov/media/172701/download
U.S. Food and Drug Administration. FDA Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant Active Ingredient After Extensive Review. Press announcement. 2024. https://www.fda.gov/news-events/press-announcements/fda-proposes-ending-use-oral-phenylephrine-otc-monograph-nasal-decongestant-active-ingredient-after
U.S. Food and Drug Administration. Key Information about Nonprescription, Over-the-Counter (OTC), Oral Phenylephrine. Accessed 2026. https://www.fda.gov/drugs/understanding-over-counter-medicines/key-information-about-nonprescription-over-counter-otc-oral-phenylephrine
AlGhamdi MA, Katib RI, Bawazir RO, et al. Efficacy of Pseudoephedrine and Oxymetazoline in Preventing Otic Barotrauma: A Systematic Review and Meta-Analysis. Otology & Neurotology. 2026. https://doi.org/10.1097/mao.0000000000004905
Moayedi S, Gizaw A, Sweet S, Sethuraman K, Witting M. Pseudoephedrine prophylaxis does not prevent middle ear barotrauma in hyperbaric oxygen therapy. Undersea & Hyperbaric Medicine. 2025. https://doi.org/10.22462/717
Buchanan BJ, Hoagland J, Fischer PR. Pseudoephedrine and air travel-associated ear pain in children. Archives of Pediatrics & Adolescent Medicine. 1999. https://doi.org/10.1001/archpedi.153.5.466
Gheorghiev MD, Hosseini F, Moran J, Cooper CE. Effects of pseudoephedrine on parameters affecting exercise performance: a meta-analysis. Sports Medicine - Open. 2018. https://doi.org/10.1186/s40798-018-0159-7
U.S. Food and Drug Administration. SUDAFED PE SINUS CONGESTION (phenylephrine hydrochloride) tablet, drug facts label. 2024. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2ca08917-1a75-4365-8520-c083e6a4225a
Salerno SM, Jackson JL, Berbano EP. Effect of oral pseudoephedrine on blood pressure and heart rate: a meta-analysis. Archives of Internal Medicine. 2005. https://doi.org/10.1001/archinte.165.15.1686
European Medicines Agency. EMA confirms measures to minimise the risk of serious side effects with medicines containing pseudoephedrine. 2024. https://www.ema.europa.eu/en/news/ema-confirms-measures-minimise-risk-serious-side-effects-medicines-containing-pseudoephedrine
Baldacci S, Santoro M, Mezzasalma L, Pierini A, Coi A. Medication use during pregnancy and the risk of gastroschisis: a systematic review and meta-analysis of observational studies. Orphanet Journal of Rare Diseases. 2024. https://doi.org/10.1186/s13023-023-02992-z
Dor S, Michael T, Levi Y, et al. Exposure to pseudoephedrine during pregnancy and major congenital malformations: Findings from a large population-based cohort of pregnancies. British Journal of Clinical Pharmacology. 2025. https://doi.org/10.1111/bcp.70001
U.S. Food and Drug Administration. Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine. https://www.fda.gov/drugs/information-drug-class/legal-requirements-sale-and-purchase-drug-products-containing-pseudoephedrine-ephedrine-and

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