tadalafil 5 MG Oral Tablet
1 INDICATIONS AND USAGE Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: • erectile dysfunction (ED) ( 1.1 ) • the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2 ) • ED and the signs and symptoms of BPH (ED/BPH) ( 1.3 ) If tadalafil is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4 ). 1.1 erectile dysfunction Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED). 1.2 benign prostatic hyperplasia Tadalafil tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 1.3 erectile dysfunction and benign prostatic hyperplasia Tadalafil tablets are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). 1.4 Limitation of Use If tadalafil is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil beyond 26 weeks is unknown [see Clinical Studies ( 14.3 )].
Dr.Reddys Laboratories Inc
OVAL YELLOW RDY 5
RDY 5 OVAL YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
TADALAFIL tablets, USP are supplied as follows: Four strengths of oval shaped tablets are available in different sizes and different shades of yellow, and supplied in the following package sizes: 2.5 mg tablets: oval shaped, biconvex, light yellow to yellow colored, film coated tablet, debossed with ‘RDY’ on one side and '2.5' on the other side. Bottles of 30’s NDC 43598-576-30 Unit dose package of 30 (3 x 10) NDC 43598-576-31 5 mg tablets: oval shaped, biconvex, light yellow to yellow colored, film coated tablet, debossed with, ‘RDY' on one side and '5' on the other side. Bottles of 30’s NDC 43598-575-30 Unit dose package of 30 (3 x 10) NDC 43598-575-31 10 mg tablets: oval shaped, biconvex, yellow colored, film coated tablet, debossed with on one side and plain on the other side. Bottles of 30’s NDC 43598-574-30 Unit dose package of 30 (3 x 10) NDC 43598-574-31 20 mg tablets: oval shaped, biconvex, yellow colored, film coated tablet, debossed with on one side and plain on the other side. Bottles of 30’s NDC 43598-573-30 Bottles of 60’s NDC 43598-573-60 Unit dose package of 30 (3 x 10) NDC 43598-573-31 16.2 Storage Store at 20°C to 25°C (68°F to 77°F); [See USP Controlled Room Temperature]. Keep out of reach of children.
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