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

taro pharmaceuticals u.s.a., inc. - 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 is contraindicated in: patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride, 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 of miscarriage, birth defects,

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

lannett company, inc. - 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 is contraindicated in: patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride, 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 of miscarriage, birth defects

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

padagis israel pharmaceuticals ltd - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 0.5 mg in 1 ml - levocetirizine dihydrochloride is indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. 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 is contraindicated in: patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride, 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 post-marketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, birth defects, or adverse maternal or

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)

micro labs limited - 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 years of age and older. 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

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

ucb australia pty ltd t/a ucb pharma division of ucb australia - levocetirizine dihydrochloride, quantity: 5 mg/ml - oral liquid - excipient ingredients: purified water; propylene glycol; glycerol; acetic acid; saccharin sodium; methyl hydroxybenzoate; propyl hydroxybenzoate; sodium acetate - xyzal oral drops are indicated for the symptomatic treatment of allergic rhinitis (including persistent rhinitis) and chronic idiopathic urticaria in adults and children aged 2 years and over.

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

perrigo new york inc - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - levocetirizine dihydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 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 is indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 months 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 dihydrochloride is indicated for the treatment of the uncomplicated

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

ucb pharma sa-nv - levocetirizine dihydrochloride 5 mg/ml - oral drops, solution - 5 mg/ml - levocetirizine (di)hydrochloride 5 mg/ml - levocetirizine

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 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 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-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence

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 seasonal allergic rhinitis in adults and children 6 years of age and older. 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. 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 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