Revatio Tablet, Film Coated
Product Images NDC 0069-4190

Product Visual Gallery

This gallery contains 28 technical images submitted to the FDA as part of the official labeling for Revatio (NDC 0069-4190). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Pfizer Laboratories Div Pfizer 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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Figure 1 (Revatio 01)

An instructional diagram showing one syringe and one vial, each with measurement markings, depicted for medication preparation or dosing.*

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Figure 2 (Revatio 02)

An instructional diagram showing steps to prepare a liquid medication bottle: pressing the cap down and turning it to open, shaking the bottle by moving it up and down while rotating it side to side, and timing 15 seconds on a stopwatch, indicating shaking or mixing time. No product labeling is visible.*

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Figure 3 (Revatio 03)

An illustration showing a graduated cylinder containing liquid, an open medicine bottle, and a syringe or dropper with a calibration scale, labeled as 'x1' to indicate a single unit. This diagram likely demonstrates how to measure or administer the liquid medication from the bottle using the syringe.*

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Figure 4 (Revatio 04)

An instructional diagram showing steps for handling a medication bottle. The first image illustrates pressing down and twisting the cap to open. The second image shows holding the bottle with one hand and moving it up and down and side to side to mix. The third image depicts a stopwatch indicating a 15-second wait time for mixing.*

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Figure 5 (Revatio 05)

Instructional illustration showing how to assemble and open a bottle with a dropper cap. The left side depicts placing a dropper insert into the bottle opening, while the right side shows a hand twisting the dropper cap to open the bottle.*

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Figure 6 (Revatio 06)

A Kaplan-Meier survival curve chart showing estimated cumulative mortality rate (%) over a 5-year period for three dosage groups: High Dose, Medium Dose, and Low Dose. The chart includes the number of subjects at risk at specified time points and depicts higher mortality rates with increased dosage.*

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Chemical Structure (Revatio 07)

Chemical structure diagram of the active ingredient in Revatio 20 mg/1, showing molecular connectivity and functional groups including sulfonamide, piperazine, and purine moieties.*

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Figure 7 (Revatio 08)

A comparative interaction chart showing the fold change and 90% confidence intervals of various drugs coadministered with sildenafil, focusing on changes in AUC and Cmax. The chart lists interacting drugs like Atorvastatin, Azithromycin, Bosentan, and others, with recommendations such as no dose adjustment or coadministration not recommended. The vertical solid line indicates the baseline effect of sildenafil alone (x=1).*

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Figure 8 (Revatio 09)

A chart showing fold change and 90% confidence intervals for various drugs interacting with sildenafil. The x-axis represents change relative to the interacting drug alone. The chart lists interacting drugs with pharmacokinetic parameters like AUC and Cmax, alongside dosing recommendations ranging mostly from 'No dose adjustment' to 'Coadministration not recommended' for ritonavir. Notes clarify drug doses and study context.*

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Figure 9 (Revatio 10)

A line chart depicting change from baseline (in meters) over weeks 4, 8, and 12 of a study. The chart compares placebo with sildenafil at 20 mg, 40 mg, and 80 mg taken three times daily (TID), showing mean values with error bars for each group across the study timeline.*

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Figure 10 (Revatio 11)

A forest plot comparing placebo and Sildenafil 20 mg TID on placebo-corrected change in 6-minute walk distance across various subgroups including baseline walk distance, etiology, pulmonary hypertension class, gender, age, mean pulmonary arterial pressure, and pulmonary vascular resistance index, displaying confidence intervals for each subgroup.*

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Figure 11 (Revatio 12)

A Kaplan-Meier survival curve comparing the percentage without a clinically worsening event over 112 days between two groups: Placebo and Sildenafil. The x-axis shows days from randomization, and the y-axis shows the percentage without the event, ranging from 0 to 100%. The Sildenafil group shows a higher percentage over time than the Placebo group.*

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Figure 12 (Revatio 13)

Line graph showing mean change from baseline in meters over 12 weeks for Revatio (sildenafil) at doses of 1 mg, 5 mg, and 20 mg taken three times daily (TID). The x-axis represents the week of study (Week 4, 8, 12), and the y-axis indicates change from baseline in meters. Error bars represent the standard error for each dosage group at each time point.*

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Logo (Revatio 14)

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Revatio 14a

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Figure A (Revatio 15)

Illustration showing labeled parts of a Revatio oral suspension bottle and a dosing syringe. The bottle includes a cap, syringe adaptor, and the liquid suspension inside. The syringe includes a tip, barrel marked with 0.5 mL and 2 mL graduations, and a plunger. The illustration is intended for clear identification of components used for dosing.*

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Figure B (Revatio 16)

Instructional illustration showing three steps: shaking a bottle with a rotating motion, timing with a stopwatch for 5 seconds, and pressing down and turning the bottle cap. This appears to depict how to prepare or open the bottle of Revatio 20 mg/1.*

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Figure C (Revatio 17)

An instructional illustration showing hands holding a bottle and inserting a syringe into the top of the bottle. The syringe is marked with measurement lines, and an arrow indicates the downward movement of the syringe into the bottle.*

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Figure D (Revatio 18)

An instructional line drawing showing a person holding an IV bag and using a syringe or tubing to extract fluid. The fluid level is marked with graduations at 0.5 mL and 2 mL.*

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Figure E (Revatio 19)

An instructional illustration showing a syringe inserted into a vial, with an upward arrow indicating the direction to pull the syringe to withdraw the liquid medication. This diagram likely demonstrates the proper method for drawing Revatio 20 mg/1 medication from its vial.*

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Figure F (Revatio 20)

An instructional illustration showing administration of Revatio using a syringe-like applicator applied to the inside of the upper lip. The diagram includes markings on the applicator representing the 20 mg/1 dose.*

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Figure G (Revatio 21)

An instructional illustration showing a faucet with liquid flowing into a syringe marked with 0.5 mL, 1 mL, and 2 mL gradations, alongside another empty syringe. The image appears to demonstrate how to fill a syringe with liquid from the faucet.*

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Revatio 21a

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Principal Display Panel (20 mg Bottle Label)

Revatio 20 mg sildenafil tablets packaging label showing the Pfizer logo and branding. The label states a package quantity of 90 tablets and indicates Rx only. Storage instructions specify 68°-77°F with excursions allowed to 59°-86°F. Distributed by Pfizer Labs Division of Pfizer Inc, made in Ireland.*

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Principal Display Panel (10 mg/12.5 mL Vial Label)

Revatio 10 mg/12.5 mL (0.8 mg/mL) sterile single-use vial label showing sildenafil injection for intravenous use. The label includes storage instructions, dosage note, Pfizer Injectables logo, NDC 0069-0338-01, and distribution information by Pfizer Labs in Ireland.*

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Principal Display Panel (10 mg/12.5 mL Vial Carton)

Revatio 10 mg/12.5 mL (0.8 mg/mL) sterile single-use vial label for sildenafil injection. The label includes storage information, dosage note, distributor Pfizer Labs, and is marked for intravenous use. The packaging features the Pfizer Injectables logo and barcode, indicating the product is made in Ireland.*

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Principal Display Panel (10 mg/mL Bottle Label)

Revatio (sildenafil) oral suspension 10 mg/mL label showing storage instructions before and after reconstitution, dosage concentration, quantity after reconstitution (112 mL), and manufacturer Pfizer Laboratories Division of Pfizer Inc. Contains warnings regarding moisture protection and expiration after 60 days from reconstitution. Grape flavored, for oral use only.*

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Principal Display Panel (10 mg/mL Bottle Carton)

Packaging label for Revatio (sildenafil) oral suspension 10 mg/mL by Pfizer Laboratories. The label indicates a 112 mL bottle following reconstitution, grape flavor, and instructions to shake well before use. Storage conditions and reconstitution directions are included, along with manufacturer details and barcodes.*

* 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.