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Respiratory agent
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Antihistamine
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For the relief of nasal and non-nasal symptoms of seasonal Allergic Rhinitis and for the treatment of chronic idiopathic Urticaria in patients 6 years of age or older.
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(Adults and children>12 years) 10 mg once daily. (Children 6 to 11 years) 2 teaspoons (10 mg) once daily.
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Category B
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Nervousness, wheezing, fatigue, abdominal pain, drowsiness.
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Pregnancy Risk Categories defined:
A: Studies in pregnant women failed to show a risk to the fetus in the first
trimester - with no evidence of risk in the later trimesters.
B: Animals studies indicate no adverse effect to the fetus, but there are no adequate,
clinical studies in pregnant women.
C: Animal studies have shown an adverse effect on the fetus, but there are no adequate,
clinical studies in humans. Despite potential risks, the drug may be useful in pregnant
women.
D: There is evidence of risk to the human fetus, but the potential benefits of use in
pregnant women may be acceptable, despite potential risks.
X: Studies in animals or humans show fetal abnormalities, or adverse reaction reports
indicate evidence of fetal risk. Warning: the risks involved clearly outweigh any
potential benefit from using the drug in pregnant women, regardless of trimester.
NR: Not rated (i.e., no information available at this time as to the potential
risks or benefits).
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