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cardinal health - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol 1.25 mg in 0.5 ml

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

ritedose pharmaceuticals, llc - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol 0.63 mg in 3 ml - levalbuterol hcl inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol hcl inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol hcl or racemic albuterol. levalbuterol hcl inhalation solution 0.63 mg2, 1.25 mg2 3 ml unit-dose vials read complete instructions carefully before using.           figure 1           figure 2           figure 3           figure 4 note: levalbuterol hcl inhalation solution should be used in a nebulizer only under the direction of a physician. more frequent administration or higher doses are not recommended without first discussing with your doctor. this solution should not be injected or administered orally. protect from light and excessive heat. store in the protective foil pouch at 20-25°c (68-77°f) [see usp controlled room temperature]. keep unopened vials in the foil pouch. once the foi

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

remedyrepack inc. - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol 1.25 mg in 3 ml - levalbuterol hcl inhalation solution, usp is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol hcl inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol hcl or racemic albuterol.

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

proficient rx lp - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol 0.63 mg in 3 ml - levalbuterol inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see warnings and precautions (5.6) ]. teratogenic effects pregnancy category c there are no adequate and well-controlled studies of levalbuterol inhalation solution in pregnant women. because animal reproduction studies are not always predictive of human response, levalbuterol inhalation solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. during worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in newborns of women treated with racemic albutero

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

amneal pharmaceuticals of new york llc - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol 0.31 mg in 3 ml - levalbuterol inhalation solution, usp is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol inhalation solution, usp is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see warnings and precautions (5.6) ]. teratogenic effects: pregnancy category c. there are no adequate and well-controlled studies of levalbuterol inhalation solution, usp in pregnant women. because animal reproduction studies are not always predictive of human response, levalbuterol inhalation solution, usp should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. during worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in newborns

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

remedyrepack inc. - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - xopenex (levalbuterol hcl) inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. xopenex inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see warnings and precautions ( 5.6) ]. teratogenic effects: pregnancy category c. there are no adequate and well-controlled studies of xopenex inhalation solution in pregnant women. because animal reproduction studies are not always predictive of human response, xopenex inhalation solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. during worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in newborns of women treated with racemic albut

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

mylan pharmaceuticals inc. - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol inhalation solution, usp is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol inhalation solution, usp is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see warnings and precautions (5.6) ]. there are no adequate and well-controlled studies of levalbuterol inhalation solution, usp in pregnant women. there are clinical considerations with the use of levalbuterol inhalation solution, usp in pregnant women [see clinical considerations] . following oral administration of levalbuterol hcl to pregnant rabbits, there was no evidence of teratogenicity at doses up to 25 mg/kg/day [approximately 108 times the maximum recommended human daily inhalation dose (mrhdid) of levalbuterol hcl for adults on a mg/m2 basis]; however,

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

sun pharmaceutical industries, inc. - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see warnings and precautions (5.6) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medication, including levalbuterol inhalation solution, during pregnancy. to enroll in mothertobaby pregnancy studies’ asthma & pregnancy study or for more information about the registry, call 1-877-311-8972 or visit www.mothertobaby.org/ongoing-study/asthma. risk summary there are no adequate and well-controlled studies of levalbuterol inhalation solution in pregnant women. there are clinical considerations with

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

nucare pharmaceuticals,inc. - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol inhalation solution, usp is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol inhalation solution, usp is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see warnings and precautions (5.6) ]. teratogenic effects: pregnancy category c. there are no adequate and well-controlled studies of levalbuterol inhalation solution, usp in pregnant women. because animal reproduction studies are not always predictive of human response, levalbuterol inhalation solution, usp should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. during worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reporte

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

northstar rxllc - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see warnings and precautions (5.6) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medication, including levalbuterol inhalation solution, during pregnancy. to enroll in mothertobaby pregnancy studies’ asthma & pregnancy study or for more information about the registry, call 1-877-311-8972 or visit www.mothertobaby.org/ongoing-study/asthma. risk summary there are no adequate and well-controlled studies of levalbuterol inhalation solution in pregnant women. there are clinical considerations with