NDC 13668-0531-94
Montelukast Sodium 4 mg/500mg GRANULE
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NDC
13668-0531-94
Generic Name
Montelukast Sodium
Brand Name
Montelukast Sodium
Strength
4 mg/500mg
Dosage Form
GRANULE
Route
ORAL
Package Size
—
Labeler
Torrent Pharmaceuticals Limited
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Montelukast sodium is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 12 months of age and older ( 1.1 ). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older ( 1.2 ). Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 6 months of age and older. Reserve us…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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