New Zealand - English - Medsafe (Medicines Safety Authority)

apotex nz ltd - montelukast sodium 10.4mg equivalent to montelukast 10 mg - tablet - 10 mg - active: montelukast sodium 10.4mg equivalent to montelukast 10 mg excipient: colloidal silicon dioxide croscarmellose sodium hyprolose hypromellose iron oxide red iron oxide yellow lactose magnesium stearate microcrystalline cellulose titanium dioxide - apo-montelukast is indicated in adult and paediatric patients 2 years of age and older for the prophylaxis and chronic treatment of asthma, including the prevention of day-time and night-time symptoms and the prevention of exercise-induced bronchospasm

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - montelukast sodium 10.4mg equivalent to montelukast 10 mg - film coated tablet - 10 mg - active: montelukast sodium 10.4mg equivalent to montelukast 10 mg excipient: colloidal silicon dioxide croscarmellose sodium magnesium stearate mannitol microcrystalline cellulose opadry blue y-22-10538 opadry clear ys-1-7006 sodium laurilsulfate - indicated in adults 15 years of age and older for the relief of day-time and night-time symptoms of seasonal allergic rhinitis and perennial allergic rhinitis.

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - montelukast sodium 10.4mg equivalent to montelukast 10 mg - film coated tablet - 10 mg - active: montelukast sodium 10.4mg equivalent to montelukast 10 mg excipient: croscarmellose sodium hyprolose   hypromellose iron oxide red iron oxide yellow macrogol 6000 magnesium stearate microcelac 100 purified water titanium dioxide - indicated in adult and paediatric patients 2 years of age and older for the prophylaxis and chronic treatment of asthma, including the prevention of day- and night-time symptoms and the prevention of exercise-induced bronchospasm.

New Zealand - English - Medsafe (Medicines Safety Authority)

multichem nz limited - montelukast sodium 10.4mg equivalent to montelukast 10 mg;   - film coated tablet - 10 mg - active: montelukast sodium 10.4mg equivalent to montelukast 10 mg   excipient: croscarmellose sodium ethanol   hyprolose lactose monohydrate magnesium stearate microcrystalline cellulose opadry tan 80w27179 purified water - indicated in adult patients 15 years of age and older for the prophylaxis and treatment of asthma, including the prevention of day- and night time symptoms and the prevention of exercise-induced bronchospasm.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - montelukast sodium 4.15mg equivalent to montelukast 4 mg - chewable tablet - 4 mg - active: montelukast sodium 4.15mg equivalent to montelukast 4 mg excipient: aspartame cherry flavour 501027 ap0551 colloidal silicon dioxide croscarmellose sodium stear-o-wet m mannitol microcrystalline cellulose - indicated in paediatric patients 2 to 5 years of age for the relief of daytime and night-time symptoms of seasonal allergic rhinitis and perennial allergic rhinitis.

United States - English - NLM (National Library of Medicine)

west ward pharmaceutical corp - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 10 mg - montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. hypersensitivity to any component of this product. pregnancy  category  b: there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, montelukast sodium should be used during pregnancy only if clearly needed. teratogenic  effect: no teratogenicity was observed in rats and rabbits at doses approximately 100 and 110 times, respectively, the maximum recommended daily oral dose in adults based on aucs [see  nonclinical toxicology (13.2)]. during worldwide marke

United States - English - NLM (National Library of Medicine)

rising health, llc - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 4 mg - montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. because the benefits of montelukast sodium may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see warnings and precautions (5.1)] , reserve use for patients who have an inadequate response or intolerance to alternative therapies. montelukast sodium is not indicated for the treatment of an acute asthma attack. montelukast sodium is contraindicated in patients with hypersensitivity to any of its components. risk summary available data from published prospective and retrospective cohort studies over decades wi

United States - English - NLM (National Library of Medicine)

aurobindo pharma limited - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 4 mg - montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. because the benefits of montelukast sodium may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see warnings and precautions (5.1)] , reserve use for patients who have an inadequate response or intolerance to alternative therapies. montelukast sodium is not indicated for the treatment of an acute asthma attack. montelukast sodium is contraindicated in patients with hypersensitivity to any of its components. risk summary    available data from published prospective and retrospective cohort studies over

United States - English - NLM (National Library of Medicine)

dr.reddy's laboratories limited - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 10 mg - montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. because the benefits of montelukast sodium may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see warnings and precautions ( 5.1)], reserve use for patients who have an inadequate response or intolerance to alternative therapies. montelukast sodium is not indicated for the treatment of an acute asthma attack. montelukast sodium is contraindicated in patients with hypersensitivity to any of its components. risk summary available data from published prospective and retrospective cohort studies over decades with

United States - English - NLM (National Library of Medicine)

torrent pharmaceuticals limited - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 4 mg - montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older.  because the benefits of montelukast sodium may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see warnings and precautions (5.1)] , reserve use for patients who have an inadequate response or intolerance to alternative therapies. montelukast sodium is not indicated for the treatment of an acute asthma attack. montelukast sodium is contraindicated in patients with hypersensitivity to any of its components. risk summary available  data  from  published  prospective  and  retrospective  cohort  studies  over