Pseudoephedrine
SUDAFED
What it isIndirect sympathomimetic that releases norepinephrine; temporary relief of nasal congestion.
Why this oneUnlike oral phenylephrine, it reliably decongests, which preserves its role despite behind-the-counter restrictions.
What limits itHypertension, insomnia, and urinary retention can end use; purchases are restricted because it is a methamphetamine precursor.
FDA-approved for
- nasal congestion (1958)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Nasal congestion (OTC decongestant) | Adults & children ≥12 yr | 2 tablets q4–6h | 2 tablets q4–6h | 8 tablets/24h |
| Nasal congestion (OTC decongestant) | Children 6–11 yr | 1 tablet q4–6h | 1 tablet q4–6h | 4 tablets/24h |
Renal Undefined
Hepatic Undefined
Doses are spaced every 4 to 6 hours; do not exceed 8 tablets in 24 hours (adults/≥12 yr) or 4 tablets in 24 hours (ages 6–11).
Instructions
- Children <6 yr: do not use.
Contraindications
- MAOIs (concurrently or within 14 days)
Cautions
- Ask a doctor before use if you have: heart disease, diabetes, thyroid disease, high blood pressure, or difficulty in urination due to prostate enlargement
- Do not exceed recommended dosage
- Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur, or if symptoms do not improve within 7 days or occur with fever
Adverse reactions
- Nervousness
- Dizziness
- Sleeplessness
Pregnancy OTC carton: if pregnant or breast-feeding, ask a health professional before use
Lactation OTC carton: if pregnant or breast-feeding, ask a health professional before use
NO BOXED WARNINGS
Principal riskHypertension and insomnia; purchase is restricted
Classes and tags
Clinical profile
Mechanism of action: Pseudoephedrine ballicule
