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1 INDICATIONS AND USAGE Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). ( 1.1 ) 1.1 Pulmonary Arterial Hypertension Tadalafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).
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CAPSULE BROWN Cipla 526
Cipla 526 CAPSULE BROWN
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
TADALAFIL tablets, USP are supplied as follows: brown colored, capsule shaped, biconvex film coated tablet with 'Cipla' debossed on one side and 526 on other side. Carton of 4 Tablets (1 x 4 Unit-dose) with child-resistant blister NDC 69097-526-16 Bottles of 60 with child-resistant closure NDC 69097-526-03 16.2 Storage Store at 25°C (77°F): excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature.] Keep out of reach of children.
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