Sildenafil Powder, For Suspension
Product Images NDC 0591-4050

Product Visual Gallery

This gallery contains 21 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 0591-4050). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Actavis Pharma, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Fig1 (Image 1)

An instructional illustration showing a syringe being used to withdraw liquid from a bottle containing suspension. The syringe is marked with volume indicators, and the image depicts the preparation or measurement of a liquid oral suspension dose.*

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Fig9 (Image 10)

A line chart showing change from baseline in meters on the y-axis over weeks of study (4, 8, 12) on the x-axis. The chart compares placebo and three sildenafil dosage groups (20 mg, 40 mg, 80 mg TID). Error bars indicate variability at each time point.*

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Fig10 (Image 11)

A forest plot showing placebo-corrected change in 6-minute walk distance (meters) for Sildenafil 20 mg TID versus placebo, stratified by baseline walk distance, etiology, pulmonary hypertension class, gender, age, mean pulmonary artery pressure (PAP), and pulmonary vascular resistance index (PVRI). Data points with confidence intervals illustrate effects across multiple subgroups.*

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Fig11 (Image 12)

A line chart showing the percentage without a clinically worsening event over time from randomization, comparing sildenafil and placebo groups. The x-axis represents days from randomization, and the y-axis represents the percentage without a clinically worsening event. Two lines are displayed: one dashed line representing sildenafil and one solid line representing placebo.*

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Fig12 (Image 13)

A line plot showing the mean change from baseline (in meters) on the vertical axis over 12 weeks of study on the horizontal axis. It compares three Sildenafil doses: 1 mg TID, 5 mg TID, and 20 mg TID, with error bars representing standard error at weeks 4, 8, and 12.*

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Ifu-fig-a (Image 14)

An instructional diagram showing a bottle of sildenafil powder for oral suspension with labeled parts: cap, syringe adaptor, and bottle. Next to it is a labeled syringe with parts named tip, barrel, and plunger, including volume markings at 0.5 mL and 2 mL.*

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Ifu-fig-b (Image 15)

An instructional illustration showing proper preparation for a suspension medication. The sequence includes holding a bottle, shaking it with up-and-down and side-to-side motions, timing a 15-second interval with a stopwatch, and pushing down and twisting off the bottle cap to open.*

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Ifu-fig-c (Image 16)

An instructional illustration showing a hand holding a bottle while another hand inserts a syringe into the bottle's opening. An arrow indicates the motion of pushing the syringe downward to withdraw liquid from the bottle, likely demonstrating how to draw a dose of sildenafil 10 mg/mL oral suspension.*

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Ifu-fig-d (Image 17)

Illustration showing the preparation of an oral suspension by drawing liquid from an inverted bottle into a syringe. A hand holds the bottle upside down while another pulls back on the syringe plunger to withdraw the suspension.*

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Ifu-fig-e (Image 18)

An instructional illustration showing a bottle filled with liquid and a syringe inserted into it, with an arrow pointing upwards indicating removal of liquid from the bottle into the syringe.*

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Ifu-fig-f (Image 19)

An instructional line drawing showing a syringe-like device being inserted into an open mouth. The image appears to demonstrate the method of oral administration for a liquid medication, suggesting the delivery of a suspension by syringe into the mouth.*

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Fig2 (Image 2)

An instructional diagram showing how to prepare a suspension from a bottle of Sildenafil powder for oral use. It illustrates twisting off the cap, shaking the bottle up and down to mix the suspension, and using a stopwatch or timer to track time, likely for proper preparation or dosing intervals.*

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Ifu-fig-g (Image 20)

An instructional diagram depicting a faucet with running water used to fill an oral syringe labeled with volume markings of 0.5 mL and 2 mL. This illustration likely shows how to properly fill and measure liquid medication for oral administration.*

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Prf 4 Pdp (Image 21)

Packaging label for Sildenafil 10 mg/mL powder for oral suspension by Actavis Pharma, Inc. The label includes instructions for reconstitution to 112 mL following mixing, states the product is grape flavored, for oral use only, and includes storage and dosing recommendations. The manufacturer is identified as Pliva Hrvatska d.o.o., Zagreb, Croatia.*

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Fig3 (Image 3)

An instructional diagram showing a syringe drawing liquid from a bottle, with measurement marks on the syringe and a graduated cylinder indicating volume measurements. The image likely illustrates proper measurement or preparation of an oral suspension.*

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Fig4 (Image 4)

Illustration showing instructions for preparing an oral suspension bottle: first pressing down and turning the cap to open, then shaking the bottle with arrows indicating a twisting and up-and-down motion, and finally waiting an indicated time shown by a stopwatch.*

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Fig5 (Image 5)

Illustration showing instructions for a liquid medication bottle: first, pressing down the stopper into the bottle top; second, placing and twisting a child-resistant cap clockwise onto the bottle. The bottle contains a suspension for oral use.*

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Fig6 (Image 6)

A cumulative mortality rate line graph over five years showing three distinct dose groups labeled High Dose, Medium Dose, and Low Dose. The x-axis represents time in years, and the y-axis shows estimated cumulative mortality rate as a percentage. The graph includes the number of patients at risk for each group at various time points.*

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Formula (Image 7)

Chemical structure diagram of Sildenafil, showing its molecular composition, functional groups, and arrangement along with its molecular formula (C22H30N6O4S·C6H8O7) and molecular weight (666.7).*

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Fig7 (Image 8)

A horizontal dot plot chart depicting the fold change and 90% confidence intervals for AUC and Cmax of interacting drugs relative to sildenafil alone. The chart includes drugs like Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir with corresponding dosing recommendations, largely indicating no dose adjustment except for Ritonavir where coadministration is not recommended.*

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Fig8 (Image 9)

A chart showing fold changes and 90% confidence intervals for various interacting drugs on sildenafil pharmacokinetics. The vertical line represents no change (x=1) in pharmacokinetic parameters such as INR, AUC, Cmax, and bleeding time, with recommendations on dose adjustments ranging from no dose adjustment to coadministration not recommended.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.