Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
SPRAY
**DOSAGE AND ADMINISTRATION: For adults and children six years of age and older:** Two or three sprays into each nostril twice daily, morning and evening. With the head upright, place the sprays nozzle into the nostril without completely occluding the nostril. During each administration, the patient should bend his head slightly forward and spray the dose into each nostril by squeezing the bottle rapidly and strongly.
NASAL
Medical Information
**INDICATIONS:** Clariclear® Nasal Spray is indicated for symptomatic relief of nasal and nasal pharyngeal congestion due to the common cold, sinusitis, hay fever or other upper respiratory allergies.
**CONTRAINDICATIONS:** Oxymetazoline-containing nasal sprays should not be used: - in patients with known hypersensitivity to oxymetazoline or other adrenergic agents, or to any component of the medicinal product; - in patients taking monoamine oxidase inhibitors (MAOIs) or in patients who have taken MAOIs in the previous two weeks; - in patients with narrow-angle glaucoma; - in patients after trans-sphenoidal hypophysectomy; - where there is inflammation of the skin and mucosa of the nasal vestibule and encrustation (rhinitis sicca); - in patients with acute cardiovascular disease or cardiac asthma; - in patients with severe high blood pressure.
R01AA05
oxymetazoline
Manufacturer Information
BAYER (SOUTH EAST ASIA) PTE LTD
Delpharm Montréal INC
Active Ingredients
Documents
Patient Information Leaflets
1.4.4_PIL_proposed.pdf
Approved: June 30, 2022