montelukast 4 MG Chewable Tablet
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 ( 1.3 ). 1.1 Asthma Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. 1.2 Exercise-Induced Bronchoconstriction (EIB) Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. 1.3 allergic rhinitis Montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older.
Mylan Pharmaceuticals Inc.
ROUND PINK ML 4
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16 HOW SUPPLIED/STORAGE AND HANDLING Montelukast Sodium Tablets are available containing 10.4 mg montelukast sodium, USP which is equivalent to 10 mg of montelukast. The 10 mg tablets are blue, film-coated, round, unscored tablets debossed with ML over 1 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5201-93 bottles of 30 tablets Montelukast Sodium Chewable Tablets are available containing 4.2 mg and 5.2 mg montelukast sodium, USP which are equivalent to 4 mg and 5 mg of montelukast, respectively. The 4 mg chewable tablets are light pink, round, unscored tablets debossed with ML over 4 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5204-93 bottles of 30 tablets The 5 mg chewable tablets are dark pink, round, unscored tablets debossed with ML over 5 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5205-93 bottles of 30 tablets Montelukast Sodium Oral Granules are available containing 4.2 mg of montelukast sodium, USP equivalent to 4 mg of montelukast. Each carton contains 30 packets containing approximately 500 mg net weight of white to off-white powder in each packet. The packets are child-resistant, tearable foil. See packet and carton for product information. They are available as follows: NDC 0378-6040-93 1 carton (30 packets per carton) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and light. Store in original package. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.
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