Fixed-dose combination
Desloratadine and Pseudoephedrine is a fixed-dose combination of a histamine-1 receptor antagonist and an alpha-adrenergic agonist indicated for relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, among other approved uses. MedsAcross supplies Desloratadine and Pseudoephedrine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
CLARINEX-D 12 HOUR is a combination product containing a histamine-1 (H1) receptor antagonist and an alpha adrenergic agonist indicated for: Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older.
Source: US FDA prescribing information
Desloratadine is a long acting tricyclic histamine antagonist with selective H 1 -receptor histamine antagonist activity. Receptor binding data indicate that at a concentration of 2 to 3 ng/mL (7 nanomolar), desloratadine shows significant interaction with the human histamine H 1 receptor. Desloratadine inhibited histamine release from human mast cells in vitro. Results of a radiolabeled tissue distribution study in rats and a radioligand H 1 -receptor-binding study in guinea pigs showed that desloratadine does not readily cross the blood brain barrier. The clinical significance of this finding is unknown. Pseudoephedrine sulfate is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa. Pseudoephedrine sulfate is recognized as an effective agent for the relief of nasal congestion due to allergic rhinitis.
Source: US FDA prescribing information
Administer CLARINEX-D 12 HOUR Extended Release Tablet by the oral route only. Do not break, chew, or crush the tablet. Swallow the tablet whole. For oral use only. Adults and adolescents 12 years of age and over: The recommended dose of CLARINEX-D 12 HOUR Extended Release Tablets is one tablet twice a day.
Source: US FDA prescribing information
CLARINEX-D 12 HOUR Extended Release Tablets are contraindicated in: Patients with hypersensitivity to any of its ingredients, or to loratadine Patients with narrow-angle glaucoma Patients with urinary retention Patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen days of stopping such treatment Patients with severe hypertension or severe coronary artery disease Hypersensitivity. Narrow-Angle Glaucoma. Urinary Retention. Patients Receiving MAO Inhibitors or within 14 days of stopping such treatment. Severe hypertension or severe coronary artery disease.
Source: US FDA prescribing information
Cardiovascular and central nervous system effects: Use with caution in patients with cardiovascular disorders. Coexisting conditions: Use with caution in patients with increased intraocular pressure, prostatic hypertrophy, diabetes mellitus, or hyperthyroidism.
Source: US FDA prescribing information
The following adverse reactions are discussed in greater detail in other sections of the label: Cardiovascular and Central Nervous System effects Increased intraocular pressure Urinary retention in patients with prostatic hypertrophy Hypersensitivity reactions Severe Skin Reactions The most common adverse reactions (reported in ≥2% of patients) were insomnia, headache, mouth dry, fatigue, somnolence, pharyngitis, dizziness, nausea, and anorexia.
Source: US FDA prescribing information
No specific interaction studies have been conducted with CLARINEX-D 12 HOUR Extended Release Tablets. Monoamine Oxidase (MAO) Inhibitors: Do not use. May potentiate the effect of pseudoephedrine on vascular system.
Source: US FDA prescribing information
Store at 25°C (77°F), excursions permitted to 15°–30°C (59°–86°F). Avoid exposure at or above 30°C (86°F). Protect from excessive moisture. Protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Desloratadine and Pseudoephedrine, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Clarinex-d 12 Hour 2.5 mg/120 mg extended-release tabletOral | Desloratadine and Pseudoephedrine | Organon | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Desloratadine and Pseudoephedrine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Desloratadine and Pseudoephedrine, including Clarinex-d 12 Hour.
Yes. The US FDA first approved Desloratadine and Pseudoephedrine on 3 March 2005, according to Drugs@FDA.
Yes. Desloratadine and Pseudoephedrine has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Desloratadine and Pseudoephedrine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Desloratadine and Pseudoephedrine is classified under ATC code R01BA52 (Desloratadine and Pseudoephedrine).
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