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Ibuprofen + Pseudoephedrine Hydrochloride
Ibuprofen + Pseudoephedrine Hydrochloride is a NSAID + decongestant combination Small molecule drug developed by Dr. Reddy's Laboratories Limited. It is currently FDA-approved for Relief of pain, fever, and nasal congestion associated with common cold and flu. Also known as: Advil® Cold and Sinus.
Ibuprofen reduces inflammation and pain by inhibiting cyclooxygenase enzymes, while pseudoephedrine constricts blood vessels in the nasal passages to relieve congestion.
Ibuprofen reduces inflammation and pain by inhibiting cyclooxygenase enzymes, while pseudoephedrine constricts blood vessels in the nasal passages to relieve congestion. Used for Relief of pain, fever, and nasal congestion associated with common cold and flu.
At a glance
| Generic name | Ibuprofen + Pseudoephedrine Hydrochloride |
|---|---|
| Also known as | Advil® Cold and Sinus |
| Sponsor | Dr. Reddy's Laboratories Limited |
| Drug class | NSAID + decongestant combination |
| Target | COX-1/COX-2 (ibuprofen); alpha-adrenergic receptors (pseudoephedrine) |
| Modality | Small molecule |
| Therapeutic area | Pain Management / Cold & Flu Symptom Relief |
| Phase | FDA-approved |
Mechanism of action
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that blocks COX-1 and COX-2 enzymes, thereby reducing prostaglandin synthesis and decreasing inflammation, pain, and fever. Pseudoephedrine is a sympathomimetic amine that acts as an alpha-adrenergic agonist, causing vasoconstriction in nasal blood vessels to reduce swelling and nasal congestion. This combination provides dual symptomatic relief for cold and flu symptoms.
Approved indications
- Relief of pain, fever, and nasal congestion associated with common cold and flu
Common side effects
- Gastrointestinal upset (nausea, dyspepsia)
- Headache
- Dizziness
- Nervousness or insomnia
- 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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ibuprofen + Pseudoephedrine Hydrochloride CI brief — competitive landscape report
- Ibuprofen + Pseudoephedrine Hydrochloride updates RSS · CI watch RSS
- Dr. Reddy's Laboratories Limited portfolio CI
Frequently asked questions about Ibuprofen + Pseudoephedrine Hydrochloride
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Related
- Drug class: All NSAID + decongestant combination drugs
- Target: All drugs targeting COX-1/COX-2 (ibuprofen); alpha-adrenergic receptors (pseudoephedrine)
- Manufacturer: Dr. Reddy's Laboratories Limited — full pipeline
- Therapeutic area: All drugs in Pain Management / Cold & Flu Symptom Relief
- Indication: Drugs for Relief of pain, fever, and nasal congestion associated with common cold and flu
- Also known as: Advil® Cold and Sinus
- Compare: Ibuprofen + Pseudoephedrine Hydrochloride vs similar drugs
- Pricing: Ibuprofen + Pseudoephedrine Hydrochloride cost, discount & access