Australia - English - Department of Health (Therapeutic Goods Administration)

torrent australasia pty ltd - montelukast sodium, quantity: 4.16 mg (equivalent: montelukast, qty 4 mg) - tablet, chewable - excipient ingredients: mannitol; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; aspartame; iron oxide red; flavour - prophylaxis and treatment of chronic asthma in adults and children 2 years of age and older. symptomatic treatment of seasonal allergic rhinitis.

Australia - English - Department of Health (Therapeutic Goods Administration)

torrent australasia pty ltd - montelukast sodium, quantity: 5.2 mg (equivalent: montelukast, qty 5 mg) - tablet, chewable - excipient ingredients: magnesium stearate; microcrystalline cellulose; mannitol; aspartame; croscarmellose sodium; iron oxide red; flavour - prophylaxis and treatment of chronic asthma in adults and children 2 years of age and older. symptomatic treatment of seasonal allergic rhinitis.

Australia - English - Department of Health (Therapeutic Goods Administration)

torrent australasia pty ltd - montelukast sodium, quantity: 10.4 mg (equivalent: montelukast, qty 10 mg) - tablet - excipient ingredients: mannitol; aspartame; magnesium stearate; croscarmellose sodium; microcrystalline cellulose; iron oxide red; iron oxide yellow; flavour - prophylaxis and treatment of chronic asthma in adults and children 2 years of age and older. symptomatic treatment of seasonal allergic rhinitis.

Australia - English - Department of Health (Therapeutic Goods Administration)

torrent australasia pty ltd - montelukast sodium, quantity: 5.2 mg (equivalent: montelukast, qty 5 mg) - tablet, chewable - excipient ingredients: mannitol; magnesium stearate; croscarmellose sodium; aspartame; microcrystalline cellulose; iron oxide red; flavour - prophylaxis and treatment of chronic asthma in adults and children 2 years of age and older. symptomatic treatment of seasonal allergic rhinitis.

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

glenmark pharmaceuticals inc., usa - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 10 mg - montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and adolescent patients 15 years of age and older. montelukast sodium tablets are indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 15 years of age and older. montelukast sodium tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients 15 years of age and older. hypersensitivity to any component of this product. 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. 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 marketing experience,

Philippines - English - FDA (Food And Drug Administration)

cadila pharamceuticals limited - drug - montelukast (as sodium) - aerokids

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

mylan institutional inc. - 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 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. hypersensitivity to any component of this product. 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. 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 marketing experience, congenital limb defects ha

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

cardinal health - 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 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. hypersensitivity to any component of this product. 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. 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 marketing experience, congenital limb defects ha

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

mylan pharmaceuticals inc. - 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 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. hypersensitivity to any component of this product. 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. 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 marketing experience, congenital limb defects hav

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

remedyrepack inc. - 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 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. hypersensitivity to any component of this product. risk summary available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk of major birth defects [see data] . in animal reproduction studies, no adverse developmental effects were observed with oral administration of montelukast to pregnant rats and rabbits during organogenesis at doses approximately 100 and 110 times, respectively, the maximum recommended human daily oral dose (mrhdod)