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Sudafed: Uses, Dosage & Safety Information

Sudafed

Sudafed

Sudafed

Pseudoephedrine hydrochloride
Sudafed is a brand of pseudoephedrine hydrochloride, a nasal decongestant for congestion from colds and allergies. It is sold without a prescription but only from behind the pharmacy counter, with photo ID and sales limits, and it must not be used with MAO inhibitors.
  • ActiveIngredient: Pseudoephedrine hydrochloride
  • DosageForm: Oral tablet, extended-release tablet, oral liquid
  • Dosage: 30 mg or 60 mg immediate-release; 120 mg or 240 mg extended-release
  • Indications: Temporary relief of nasal and sinus congestion from the common cold, hay fever or upper respiratory allergies.
  • Manufacturer: Originator: Johnson & Johnson. Generics from multiple manufacturers.
  • Storage: Store at 20-25 C (68-77 F). Protect from light and moisture.
  • Drug Status: Behind the Counter
Drug Status: Behind the Counter
Description

What is Sudafed?

Sold without a prescription, but from behind the counter
Pseudoephedrine products are kept behind the pharmacy counter under federal law: customers show photo ID and sign a logbook, and daily and 30-day sales limits apply.1

Sudafed is a brand of pseudoephedrine hydrochloride, a nasal decongestant sold under the FDA’s over-the-counter monograph; the 12 Hour tablet releases it over the day.4

The Combat Methamphetamine Epidemic Act of 2005 moved pseudoephedrine behind the counter because it can be used to make methamphetamine; the rules concern the sale, not the medicine’s safety.2

Pseudoephedrine narrows swollen blood vessels in the nose; it can also raise blood pressure and heart rate, which is why several conditions call for a doctor’s advice first.

General Instructions

How to Take Sudafed

How much

Adults and children 12 and over take 1 tablet every 12 hours, and no more than 2 tablets in 24 hours. It is not for children under 12.1

At the pharmacy counter

Bring photo identification; the pharmacist records the sale in a logbook, and federal limits cap how much pseudoephedrine can be sold to one person per day and per month. The limits are counted across all pseudoephedrine products, including combination cold medicines.

Check your other medicines

Do not use it with a prescription MAO inhibitor or within 2 weeks of stopping one; ask a pharmacist if you are unsure.1

Storage

Store at 20 to 25°C (68 to 77°F) in a dry place, protected from light.1

What not to do

Do not exceed the dose, and stop and ask a doctor if nervousness, dizziness or sleeplessness occurs or symptoms last more than 7 days.1

Side Effects

What Are the Side Effects of Sudafed?

The Drug Facts list the effects that mean stopping and asking a doctor.1

Reactions in the Labelling
FrequencyEffectNotes
Frequency not stated in labellingNervousnessStop and ask a doctor
Frequency not stated in labellingDizzinessStop and ask a doctor
Frequency not stated in labellingSleeplessnessStop and ask a doctor

Source: 1

Seek immediate medical attention if:
  • Chest pain, a racing heartbeat or severe headache
  • Fainting
  • Signs of an allergic reaction
Uses

What is Sudafed Used For?

Labelled Indications
IndicationNotes
Nasal congestion from colds, hay fever or other upper respiratory allergiesTemporary relief
Sinus congestion and pressureTemporary relief

Source: 1

Sudafed relieves congestion only; it does not treat an infection or allergy itself.1

Safety advice

Interactions Alcohol:

Use with caution
Alcohol does not interact directly, but both disturb sleep and pseudoephedrine already causes insomnia in many people. The combination compounds that.

Interactions Other Medications:

Consult your doctor
MAO inhibitors are an absolute contraindication, including for 14 days after stopping. Beta-blockers, other antihypertensives and any second decongestant require assessment. See Interactions.

Special Groups Pregnancy:

Consult your doctor
Use is generally avoided in the first trimester and requires advice at any stage, particularly with raised blood pressure, where the vasoconstrictor effect is the concern.

Special Groups Breastfeeding:

Use with caution
Pseudoephedrine passes into breast milk and can reduce milk supply. Discuss with a clinician before use while nursing.

Special Groups Elderly:

Use with caution
More sensitive to cardiovascular and central effects. Urinary retention in prostatic enlargement and confusion are the specific risks; renal clearance also declines with age.

Special Groups Children:

Consult your doctor
Not for children under 4 under any circumstances. From 4 to 11 years use reduced doses of the immediate-release form only, on advice.

Effects on Activities Driving:

Use with caution
Dizziness and nervousness occur in some people. Establish your response before driving.

Effects on Activities Operating Machinery:

Use with caution
The same applies as for driving; tremor and restlessness are the relevant effects.
Regulatory status and dispensing

Sudafed is sold without a prescription but only from behind the pharmacy counter, with photo ID, a logbook and federal sales limits.2

Warnings

Critical Warnings for Sudafed Use

MAO inhibitors

Contraindicated: Use while taking a prescription MAO inhibitor or within 2 weeks after stopping it.1

Children under 12

Contraindicated: Use in children under 12 years of age.1

Ask a doctor first

Heart disease, high blood pressure, thyroid disease, diabetes or trouble urinating because of an enlarged prostate.1

Stop use

Stop and ask a doctor if nervousness, dizziness or sleeplessness occur, or symptoms do not improve within 7 days or come with fever.1

See Interactions.

Dosage

Dosage

Sudafed Products
FormulationActive IngredientsClinical Note
Extended-release tablets, pseudoephedrine HCl 120 mgPseudoephedrine hydrochloride12-hour product
Kidney diseasePseudoephedrineNot addressed in the Drug Facts; ask a doctor
Liver diseasePseudoephedrineNot addressed in the Drug Facts; ask a doctor
Children under 12PseudoephedrineDo not use this product

Source: 14

Exceeding the dose
Taking more than directed can cause nervousness, dizziness, sleeplessness and a fast heartbeat; contact Poison Control or emergency services.1
Interactions

What Does Sudafed Interact With?

The Drug Facts list one interacting drug class; ask a pharmacist about others you take.

Interactions by Severity
Interacting SubstanceEffect and RiskSeverityDocumentation
Prescription MAO inhibitorsDangerous rise in blood pressureContraindicatedExcellent — labelled Do Not Use

Source: 1

FAQs
Federal law moved pseudoephedrine behind the counter because it can be used to make methamphetamine; customers show ID and sign a logbook.
One tablet every 12 hours, no more than 2 tablets in 24 hours, for adults and children 12 and over.
People with heart disease, high blood pressure, thyroid disease, diabetes or prostate-related urinary trouble.
Not with a prescription MAO inhibitor or within 2 weeks of stopping one; ask a pharmacist about other antidepressants.
No. Sudafed PE contains phenylephrine, a different decongestant sold on open shelves.
Evidence and Reported Data

Evidence Scope

Established: pseudoephedrine relieves nasal congestion and is sold behind the counter under federal law. Unknown: the frequency of side effects, which the Drug Facts do not give.1

What has been reported to the FDA

FAERS has received 45,997 reports naming pseudoephedrine since 2004. Data current to 30 July 2026.3

How to read this table

FAERS records what was reported, not what the medicine caused, and has no denominator – no count can become a rate.

Pseudoephedrine appears in a large number of multi-ingredient cold and allergy products, so many reports name it alongside several other active ingredients. Attribution to pseudoephedrine specifically is not possible from the report alone.

Who was this medicine studied in?

Sudafed is marketed under the over-the-counter monograph and has no Drug Trials Snapshot.5

Where to report and verify

Routing to Official Registries
What you needWhere to go
Report a side effectFDA MedWatch
Pregnancy-specific dataMotherToBaby
Full prescribing informationDailyMed
Verify a pharmacy websiteFDA BeSafeRx · LegitScript
References

References

  1. FDA OTC Drug Facts, Sudafed Sinus Congestion 12 Hour (pseudoephedrine HCl 120 mg) — Uses, Warnings, Directions, Other information
    Label effective 2025-09-15 · Accessed 2026-09-28
    Used for: uses, MAOI warning, ask-a-doctor conditions, dosing, storage.
    dailymed.nlm.nih.gov — DailyMed
  2. Combat Methamphetamine Epidemic Act of 2005 — US Drug Enforcement Administration, Diversion Control Division
    Accessed 2026-09-28
    Used for: behind-the-counter sale, photo ID and logbook, daily and 30-day sales limits.
    deadiversion.usdoj.gov
  3. openFDA — FDA Adverse Event Reporting System, drug event query for pseudoephedrine
    Data cut 2026-07-30 · Accessed 2026-09-28
    Used for: report totals, serious counts and most reported terms.
    open.fda.gov — openFDA
  4. FDA National Drug Code Directory — Sudafed listings
    Directory current · Accessed 2026-09-28
    Used for: current US marketing.
    accessdata.fda.gov — NDC Directory
  5. FDA — Drug Trials Snapshots programme scope
    Programme current · Accessed 2026-09-28
    Used for: confirmation that Snapshots cover novel drugs approved from 2015.
    fda.gov — Drug Trials Snapshots

Review cycle. Clinical review completed 28 September 2026. Next review due by 28 September 2027, or earlier if the labelling is revised.

Disclaimer

Disclaimer: The information on this site is provided for informational purposes only and is not medical advice. It does not replace professional medical consultation, diagnosis, or treatment. Do not self-medicate based on the information presented on this site. Always consult with a doctor or other qualified healthcare professional before making any decisions about your health.