Last reviewed · How we verify
Pseudoephedrine/Paracetamol
This combination drug reduces nasal congestion via pseudoephedrine's sympathomimetic action and alleviates pain and fever via paracetamol's analgesic and antipyretic effects.
This combination drug reduces nasal congestion via pseudoephedrine's sympathomimetic action and alleviates pain and fever via paracetamol's analgesic and antipyretic effects. Used for Symptomatic relief of nasal congestion, headache, and fever associated with common cold and influenza.
At a glance
| Generic name | Pseudoephedrine/Paracetamol |
|---|---|
| Also known as | Sinutab |
| Sponsor | McNeil AB |
| Drug class | Decongestant/analgesic combination |
| Target | Alpha-1 adrenergic receptor (pseudoephedrine); COX inhibition (paracetamol) |
| Modality | Small molecule |
| Therapeutic area | Cold and Flu Symptom Relief |
| Phase | FDA-approved |
Mechanism of action
Pseudoephedrine is an alpha-1 adrenergic agonist that constricts blood vessels in the nasal mucosa, reducing swelling and congestion. Paracetamol (acetaminophen) inhibits prostaglandin synthesis in the central nervous system, reducing pain perception and lowering fever set point. Together, they provide symptomatic relief of cold and flu symptoms.
Approved indications
- Symptomatic relief of nasal congestion, headache, and fever associated with common cold and influenza
Common side effects
- Insomnia or nervousness
- Headache
- Dizziness
- Nausea
- Liver toxicity (paracetamol at high doses)
Key clinical trials
- Opioids Continue to Play a Primary Role in the Management of Perioperative Pain Due to Opioid-Free Anesthesia in Open Heart Surgery.
- Does Type of Anesthesia Influence Inflammation Change After Breast Surgery? (NA)
- Hemodynamics During Induction of General Anesthesia After Prophylactic Ephedrine, Phenylephrine or Norepinephrine. (PHASE4)
- Benefits of Opioid Free Anesthesia on Morphine Consumption in Gastric Bypass (NA)
- Dexmedetomine as Adjuvant for Spinal Anesthesia in Elective Cesarian Sections : a Pilot Study (PHASE3)
- Comparative Study Between Caudal Epidural Block and Bilateral Erector Spinae Plane Block in Lumbosacral Spine Surgeries. (NA)
- Clinical Trial Of The Effectiveness Of The Product Cloratadd D (Loratadine + Pseudoephedrine Sulfate) Produced By The Laboratory EMS S/A, Compared To The Drug Claritin D Produced By Schering-Plough S/A, In Patients With Allergic Rhinitis (PHASE3)
- Ketofol Versus Propofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients. (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pseudoephedrine/Paracetamol CI brief — competitive landscape report
- Pseudoephedrine/Paracetamol updates RSS · CI watch RSS
- McNeil AB portfolio CI