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ibuprofen; pseudoephedrine HCl
Ibuprofen reduces pain and inflammation by inhibiting cyclooxygenase enzymes, while pseudoephedrine constricts blood vessels in the nasal passages to relieve congestion.
Ibuprofen reduces pain and inflammation by inhibiting cyclooxygenase enzymes, while pseudoephedrine constricts blood vessels in the nasal passages to relieve congestion. Used for Pain and fever relief associated with the common cold, flu, and upper respiratory infections with nasal congestion, Temporary relief of sinus pressure and congestion.
At a glance
| Generic name | ibuprofen; pseudoephedrine HCl |
|---|---|
| Sponsor | Johnson & Johnson Consumer and Personal Products Worldwide |
| Drug class | NSAID + sympathomimetic decongestant combination |
| Target | COX-1/COX-2 (ibuprofen); alpha-adrenergic receptors (pseudoephedrine) |
| Modality | Small molecule |
| Therapeutic area | Pain Management / Cold & Allergy |
| Phase | FDA-approved |
Mechanism of action
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that blocks COX-1 and COX-2 enzymes, reducing prostaglandin synthesis and thereby decreasing pain, fever, and inflammation. Pseudoephedrine is a sympathomimetic decongestant that acts as an alpha-adrenergic agonist, causing vasoconstriction in nasal blood vessels to reduce swelling and congestion. This combination product addresses both pain/inflammation and nasal congestion symptoms.
Approved indications
- Pain and fever relief associated with the common cold, flu, and upper respiratory infections with nasal congestion
- Temporary relief of sinus pressure and congestion
Common side effects
- Nausea
- Dyspepsia / stomach upset
- Nervousness / insomnia
- Headache
- Dizziness
- Tachycardia
Key clinical trials
- Bioequivalence of a Fixed Dose Combination Tablet Containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl Compared to Two Film Coated Fixed Dose Combination Tablets RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) Administered in Healthy Subjects (PHASE1)
- Bioequivalence of a Fixed Dose Combination Tablet Containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl Compared to RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a Fixed Dose Combination Tablet Administered in Healthy Volunteers. (PHASE1)
- Single-Dose Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride Tablets (PHASE1)
- Treatment of Orthostatic Hypotension in Autonomic Failure (PHASE1)
- A Study to Determine if Ibuprofen in Combination With Pseudoephedrine HCl is More Effective Than Each Drug Alone in the Treatment of Nighttime Bedwetting (PHASE2)
- Bioequivalence Study of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets Under Fed Conditions (PHASE1)
- Bioequivalency Study of Ibuprofen 200 mg and Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's Under Fasting Conditions (PHASE1)
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 |
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