Sildenafil (Page 7 of 7)

INSTRUCTION FOR USE

Sildenafil (Sil den’ a fil) for oral suspension

Read this Instructions for Use for Sildenafil for oral suspension before you start taking and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

Important information:

•Your pharmacist should tell you how to measure Sildenafil for oral suspension by using the oral syringe provided in the pack.
•Sildenafil for oral suspension should only be given using the oral syringe supplied with each pack.
•Sildenafil for oral suspension should not be mixed with any other medicine or flavoring.

Supplies you will need to take Sildenafil for oral suspension:

•Bottle of Sildenafil for oral suspension with syringe adaptor fitted in neck of bottle
•Oral syringe (as supplied by pharmacist). (See Figure A)

Figure A

1. Shake the bottle of Sildenafil for oral suspension for 10 seconds before each use. (See Figure B)

2. Remove the cap. Open the bottle by pushing downward on the cap and twisting it in the direction of the arrow (counter-clockwise). (See Figure B)

Figure B 3. Insert the tip of the oral syringe into the adaptor while the bottle is upright, on a flat surface. Fully push down (depress) the plunger of the syringe. (See Figure C)

Figure C

4. Turn the bottle upside down while holding the oral syringe in place. Slowly pull back the plunger of the oral syringe until the bottom of the plunger is even with the graduation markings on the syringe for the prescribed dose for you. Take your dose of Sildenafil for oral suspension exactly as prescribed by your doctor. If air bubbles can be seen, slowly push the oral suspension in the syringe back into the bottle. Repeat steps 3 and 4. (See Figure D)

Figure D

5. Turn the bottle back upright with the oral syringe still in place. Remove the oral syringe from the bottle by pulling straight up on the barrel of the oral dosing syringe. (See Figure E)

Figure E

6. Put the tip of the oral syringe into your mouth. Point the tip of the oral syringe towards the inside of the cheek. Slowly push down the plunger of the oral syringe. (See Figure F)

Figure F

7. Replace the cap on the bottle, leaving the bottle adaptor in place. Wash the oral syringe as instructed below.

8. The syringe should be washed after each dose. Pull the plunger out of the barrel and rinse both parts with water. (See Figure G)

Figure G

9. Dry all parts with a clean paper towel. Push the plunger back into the barrel. Store the syringe with Sildenafil for oral suspension in a clean safe place.

Administer Sildenafil for oral suspension using the oral syringe supplied with each pack. Refer to the patient instructions for use for more detailed instructions for use. Discard any unused suspension after the expiration date written on the bottle.

How should I store Sildenafil for oral suspension?

•Store Sildenafil for oral suspension reconstituted oral suspension below 30°C (86°F) or in a refrigerator between 2°C to 8°C (36°F to 46°F).
•Do not freeze Sildenafil for oral suspension.
•Throw away (discard) Sildenafil for oral suspension after 60 days.•Keep Sildenafil for oral suspension and all medicines away from children.

This Instruction for Use has been approved by the U.S. Food and Drug Administration.

Distributed By:

Virtus Pharmaceuticals, LLC

Langhorne, PA 19047

1-888-848-3593

Revised: 05/2021

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SILDENAFIL sildenafil for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69543-419 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILDENAFIL CITRATE (SILDENAFIL) SILDENAFIL 10 mg in 1 mL

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID SILICON DIOXIDE SODIUM BENZOATE SORBITOL SUCRALOSE TITANIUM DIOXIDE TRISODIUM CITRATE DIHYDRATE XANTHAN GUM

Product Characteristics Color WHITE (White to off-white) Score Shape Size Flavor GRAPE Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69543-419-72 1 BOTTLE in 1 CARTON contains a BOTTLE 1 112 mL in 1 BOTTLE This package is contained within the CARTON (69543-419-72)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA213814 08/02/2021

Labeler — Virtus Pharmaceuticals, LLC (079659493)

Registrant — Appco Pharma LLC (078510186)

Establishment
Name	Address	ID/FEI	Operations
Appco Pharma LLC		078510186	ANALYSIS (69543-419), MANUFACTURE (69543-419), PACK (69543-419)

Revised: 07/2021 Virtus Pharmaceuticals, LLC