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

dispensing solutions, inc. - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. pediatric use information in pediatric patients (age 6 months to 5 years) is approved for ucb inc.'s levocetirizine dihydrochloride drug product labeling. however, due to ucb inc.'s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. the use of levocetirizine dihydrochloride tablets is contraindicated in: patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, or to cetirizine. observed reactions range from urticaria to anaphylaxis [see adverse reactions ( 6.2) ]. patients with end-stage renal disease (clcr < 10 ml/min) and patients undergoing hemodialysis. children 6 months to 11 years of age with impaired renal function. pregnancy category b there are no adequate and well-controlled studies in preg

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

apotex corp. - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 0.5 mg in 1 ml - levocetirizine dihydrochloride oral solution is indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. levocetirizine dihydrochloride oral solution is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. the use of levocetirizine dihydrochloride oral solution is contraindicated in: patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride oral solution, or to cetirizine. observed reactions range from urticaria to anaphylaxis [see adverse reactions (6.2) ]. patients with end-stage renal disease (clcr < 10 ml/min) and patients undergoing hemodialysis children 6 months to 11 years of age with impaired renal function risk summary available data from published literature and postmarketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-associated risks o

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

proficient rx lp - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. the use of levocetirizine dihydrochloride tablets is contraindicated in: patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, or to cetirizine. observed reactions range from urticaria to anaphylaxis [see adverse reactions (6.2) ]. patients with end-stage renal disease (clcr < 10 ml/min) and patients undergoing hemodialysis. children 6 months to 11 years of age with impaired renal function. 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, levocetirizine dihydrochloride

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

remedyrepack inc. - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. the use of levocetirizine dihydrochloride tablets are contraindicated in: patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, or to cetirizine. observed reactions range from urticaria to anaphylaxis [ see adverse reactions ( 6.2) ]. patients with end-stage renal disease (cl cr <10 ml/min) and patients undergoing hemodialysis.  children 6 months to 11 years of age with impaired renal function risk summary available data from published literature and postmarketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. in animal reproduction studies, there was no evid

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

pd-rx pharmaceuticals, inc. - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. the use of levocetirizine dihydrochloride tablets is contraindicated in: patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, or to cetirizine. observed reactions range from urticaria to anaphylaxis [see adverse reactions (6.2) ]. patients with end-stage renal disease (cl cr < 10 ml/min) and patients undergoing hemodialysis. children 6 months to 11 years of age with impaired renal function. risk summary available data from published literature and postmarketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-associat

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

physicians total care, inc. - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - enter section text here levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. pediatric use information in pediatric patients (age 2 to 5 years) with seasonal allergic rhinitis is approved for ucb inc.'s levocetirizine dihydrochloride drug product. however, due to ucb inc.'s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 years of age and older. pediatric use information in pediatric patients (age 6 months to 5 years) with perennial allergic rhinitis is approved for ucb inc.'s levocetirizine dihydrochloride drug product. however, due to ucb inc.'s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. levocetirizine dihydrochlorid

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

yiling pharmaceutical, inc. - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - 1.2 chronic idiopathic urticaria levocetirizine dihydrochloride is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. the use of levocetirizine dihydrochloride tablet is contraindicated in: 4.1 patients with known hypersensitivity patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, or to cetirizine. observed reactions range from urticaria to anaphylaxis [see adverse reactions (6.2)]. 4.2 patients with end-stage renal disease patients with end-stage renal disease (clcr < 10 ml/min) and patients undergoing hemodialysis 4.3 pediatric patients with impaired renal function children 6 months to 11 years of age with impaired renal function 8.1 pregnancy risk summary available data from published literature and postmarketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-ass

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

avkare, inc. - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - 1.2 perennial allergic rhinitis levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 months of age and older. the use of levocetirizine dihydrochloride tablet is contraindicated in: 4.1 patients with known hypersensitivity patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, or to cetirizine. observed reactions range from urticaria to anaphylaxis [see adverse reactions (6.2)]. 4.2 patients with end-stage renal disease patients with end-stage renal disease (clcr < 10 ml/min) and patients undergoing hemodialysis 4.3 pediatric patients with impaired renal function children 6 months to 11 years of age with impaired renal function 8.1 pregnancy pregnancy category b there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictiv

Malta - English - Medicines Authority

fair-med healthcare gmbh planckstr. 13, 22765 hamburg, germany - levocetirizine dihydrochloride - film-coated tablet - levocetirizine dihydrochloride 5 mg - antihistamines for systemic use

Malta - English - Medicines Authority

teva pharma b.v. swensweg 5, 2031 ga haarlem, netherlands - levocetirizine dihydrochloride - film-coated tablet - levocetirizine dihydrochloride 5 mg - antihistamines for systemic use