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REVATIO® (sildenafil citrate) How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

REVATIO tablets are supplied as white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows:

REVATIO Tablets
Package Configuration Strength NDC Engraving on Tablet
Bottle of 90 Tablets 20 mg 0069-4190-68 RVT20

Recommended Storage for REVATIO Tablets: Store at controlled room temperature 20°C – 25°C (68°F – 77°F) ; excursions permitted to 15°C – 30°C (59°F –86°F) [see USP Controlled Room Temperature].

REVATIO injection is supplied as a clear, colorless, sterile, ready to use solution containing 10 mg sildenafil/12.5 mL presented in a single-use glass vial.

REVATIO Injection
Package Configuration Strength NDC
Vial individually packaged in a carton 10 mg /12.5 mL 0069-0338-01

Recommended Storage for REVATIO Injection: Store at controlled room temperature 20°C – 25°C (68°F – 77°F); excursions permitted to 15°C – 30°C (59°F – 86°F) [see USP Controlled Room Temperature].

REVATIO powder for oral suspension is supplied in amber glass bottles. Each bottle contains white to off-white powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil). Following constitution, the volume of the oral suspension is 112 mL (10 mg sildenafil/mL). A 2 mL oral dosing syringe (with 0.5 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided.

REVATIO Powder for Oral Suspension
Package Configuration Strength NDC
Powder for oral suspension - bottle 10 mg/mL (when reconstituted) 0069-0336-21

Recommended storage for REVATIO for oral suspension: Store below 30°C (86°F) in the original package in order to protect from moisture.

Constituted Oral Suspension

Store below 30°C (86°F) or in refrigerator at 2°C to 8°C (36° F – 46°F). Do not freeze. The shelf-life of the constituted oral suspension is 60 days. Any remaining oral suspension should be discarded 60 days after constitution.

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